Health risks posed by silicone implants in general with special attention to breast implants : final study.
Date: 2018-03-12
Institutions: Directorate-General for Parliamentary Research Services
Subjects: aesthetic surgery, health risk, medical device

HEALTH RISKS POSED BY SILICONE 
IMPLANTS IN GENERAL 
 WITH SPECIAL ATTENTION 
 TO BREAST IMPLANTS 

Final Study 

Working document for the STOA Panel 

Luxembourg, June 2000  

              PE 168.396/Fin.St./rev. 

QA-48-02-618-EN-N

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Cataloguing data: 

Silicone breast implants 

Title: 

HEALTH RISKS POSED BY SILICONE IMPLANTS IN GENERAL 
WITH SPECIAL ATTENTION TO BREAST IMPLANTS. 

Workplan Ref.:  

EP/IV/A/STOA/99/20/02 

Publisher: 

Author: 

European Parliament 
Directorate General for Research 
Directorate A 
The STOA Programme 

Prof. José MARTÍN-MORENO, Director, 
Dr. L. Gorgojo 
Dr. J. Gonzalez 
Ms. W. Wisbaum  
Escuela Nacional de la Sanidad, Madrid 

Editor: 

Graham Chambers 
Head of STOA Team 

Date: 

June 2000 

PE number: 

PE 168.396/Fin.St./rev 

This document is a working Document for the 'STOA Panel'. It is not an official publication of 
STOA. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
Final report for STOA 

Silicone breast implants 

This document does not necessarily represent the views of the European Parliament 

Final Report (Study) 
“Health risks posed by silicone implants in general, 
with a special attention to breast implants” 

by Dr. J Martin-Moreno, Dr. L Gorgojo, Dr. J Gonzalez and Ms. W Wisbaum 

11 May 2000 

Table of contents 

Acknowledgements 

Abstract 

1. Final Options Brief 

2. Final Executive Summary 

3. Final Study 

3.1. Options 

3.1.1. Background information for relevant European options 

3.1.1.1. Options for implant devices. Foreseeable market forces and social dynamics for 
silicone implants diffusion and control 

3.1.1.2. Summary of  European and international efforts and investments in this field 

3.1.1.3. Review of European legislation 

3.1.1.3.1. Directives related to implants/medical devices 
3.1.1.3.2. Directives related to consumer protection 
3.1.1.3.3. Other relevant legislative references 

3.1.1.4. Consultation with EU Member States, current situation of implants distribution 
and use, government position, legislative and health policies adopted  

3.1.1.5. Review of other relevant references related to international legislation 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

3.1.1.6. EU instruments related to harmonisation of legislation, and medical device 
control 

3.1.2. Operational, potential options, including alternative approaches for new European 
Directives 

3.2. Arguments and evidence 
3.2.1. Background information, including arguments for and against the health risks of silicone 
implants 

3.2.1.1. General and specific health risks posed by silicone implants, their effects on the 
body, the brain and the nerves; possible influences on the genetic make up 
3.2.1.2. Life span effects of silicone implants after 4, 8 and 12 years 
3.2.1.3. Post-operational effects and follow-up 
3.2.1.4. Conclusions 

3.2.2. Overview of relevant primary research and reviews. Period 1990-1999 

3.2.2.1. Research currently taking place in the EU 
3.2.2.2. Current research in other parts of the world 
3.2.2.3. Conclusions 

3.2.3. Primary information obtained 

3.2.3.1. Surgeons 
3.2.3.2. Women’s group: European Council on Women’s Health 
3.2.3.3. Scientific Societies 
3.2.3.4. Patients 
3.2.3.5. Manufacturers 
3.2.3.6. Researchers 
3.2.3.7. European Union Countries 
3.2.3.8. Other Countries 
3.2.3.9. Self-help groups 

3.2.4. Analysis of potential legal precautions to be envisaged 

3.2.4.1.Alternative levels of precaution potentially recommended taking into account the 
current knowledge about health issues. 
3.2.4.2. Implications of new legislature.  

3.3. Technical File 

3.3.1. Basic terminology and concepts  
3.3.1.1. Silicon/Silica 
3.3.1.2. Silicone and polydimethylsiloxane (PDMS) 

3.3.2. General exposure to silicones. The use of silicone in medical devices 

3.3.3. Breast implants. Shells and fillings. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

3.3.3.1. Alternative implants accordingly to the filling material 
3.3.3.1.1  Silicone gel filled implants 
3.3.3.1.2.  Saline filled implants 
3.3.3.1.3.   Other implants 

3.3.4 . Technical summary about silicone implants and their potential effects 

3.3.4.1.  Potential benefits 
3.3.4.2.  Potential risks 
3.3.4.3.  Risks & benefits: The challenging decisionò 

4. Cited bibliography 

 
 
 
 
 
 
 
 
 
 
 
 
  
 
Final report for STOA 

Silicone breast implants 

ANNEX 

Charts with overall response rates 

Tables 1-5 

Table 1: Serious health effects in studies in relation to SBIs 
Table 2: Summary of surgeons´ responses 
Table 3: Summary of patients´ responses 
Table 4: Summary of manufacturers´ responses 
Table 5: Summary of governments´ responses 

Annexes A, B, C:  original materials (sent in boxes under separate cover) 

Annex D: References 

Annex D1 (file “ BIBLIOGRAPHY): 

Other available references (sent under separate 
cover) 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Acknowledgements: 

Silicone breast implants 

We would like to express special gratitude to the STOA/European Parliament for giving us this 
opportunity; to the Competent Authorities on Medical Devices in European Union countries for the latest 
country-specific information; to self-help groups from UK/Scotland, The Netherlands, Germany, Belgium, 
Switzerland, and Iceland, and individual women with silicone breast implants, for all of the materials and 
information, and for sharing personal stories; to manufacturers, for all the documents, time and 
information; to individual researchers/experts on silicone breast implants, who have provided us with 
their insight and with some of the latest scientific evidence on the subject; to contacted surgeons and 
individual patients, for completing our questionnaires; to Scientific Societies, for answering our questions 
and providing us information; to the National Library of Health Sciences of Spain (specifically to Ms. 
Mercedes Alastruey and Ms. Cristina Gavin), and special mention to specific individuals who provided us 
with invaluable additional information and insight, including Dr. Jon Samet (Johns Hopkins University), 
Dr. Peter Boyle (European Institute of Oncology), Dr. Roger Herdman (Institute of Medicine, US), Dr. 
Louise Brinton (National Cancer Institute, US), Dr. Marita Eisenmann-Klein (European Committee on 
Quality Assurance and Medical Devices in Plastic Surgery), Dr. Samie Allen (Center for Devices and 
Radiologic Health, US), Dr. Ulrich Hinderer (International Plastic, Reconstructive and Aesthetic 
Foundation(IPRAF), Spain), Dr. Julio Villalba (University Hospital of Granada, Spain), Ms. Charo Giner 
(Department of Epidemiology and Biostatistics, National School of Public Health of Spain), Dr. Julie 
Kent (University of West of England) and Ms. Peggy McGuire (European Institute of Women´s Health), 
to whom we are especially grateful. Finally, we are very appreciative to the Spanish authorities on medical 
devices, including Dr. Carmen Abad and Dr. Teresa Millan (both of the Directorate General for 
Pharmaceuticals and Medical Devices), and Dr. Rosa Cepeda (National Centre for Pharmaco-biology). 
This is not an all-inclusive list, and we would like to thank all of you not mentioned here who have 
contributed to this study. All of these people have helped shed light on this complex area and make this 
report what it is. It should be noted, however, that only the study team is responsible for any weaknesses, 
limitations or problems with this report. 

 
 
 
 
 
 
 
 
Final report for STOA 

Abstract 

Silicone breast implants 

The main objective of this project is to present well-informed and relevant alternative policy options to the 
European Parliament on silicone (breast) implants, based on a comprehensive, unbiased analysis of the 
scientific literature on the subject and of interested actors. With the aim of reflecting all views on this 
issue (negative and positive), we have interviewed patients, and have contacted and received information 
from self-help groups, women’s groups, reconstructive surgeons, silicone breast implant manufacturers, 
countries, and scientific societies. 
Silicone implants were used for years before there was regulation or surveillance of their use. A great deal 
of focus has been given to silicone breast implants since the early 90s, leading to many different 
epidemiological studies that have driven to highly consistent results showing no evidence of a serious risk 
for major diseases. But because the studies started so recently, most have not been able to look at long-
term effects, have mainly focused on certain systemic diseases (cancer and connective tissue diseases—the 
main two causes of concern—) and have not always controlled for the different types of implants.  This 
must be considered in light of the fact that a significant body of women claim to be experiencing 
symptoms which they think are associated with their implants. Moreover, local complications are obvious 
matters of concern. In light of this complex reality, a range of three potential operational policy options 
could be considered: 
Option 1: status quo: no ban, keep application of current legal framework: Pros: good legislative basis in 
place, inconclusive evidence of serious risks, maintain stability; Cons: evidence points to need for proper 
European harmonisation; self-help groups and others have called for an immediate ban. 
Option 2: ban on silicone breast implants due to lack of complete information regarding risks and 
petitions by some groups. Pros: most conservative option based on lack of complete understanding; 
desired option by some groups. Cons: large demands by women for these implants and available 
alternatives could even be worse; studies point to inconclusive evidence of risks of serious health 
concerns, and underline local complications (also present in alternatives) as main health concern; potential 
for economic damage to industry; non-consistent with the standard precautionary principles. 
Option 3: no complete ban, but the adoption and implementation of critical specific measures to improve 
information for patients, tracking and surveillance, quality control and assurance and key research. Pros: 
studies indicate that local complications (also present in alternatives) are largest cause for concern. Cons: 
need to make a real investment for co-ordinated efforts and research to happen; self-help groups and 
others have called for an immediate ban.  

 
 
 
 
 
 
 
 
Final report for STOA 

1. Final Options Brief 

Silicone breast implants 

The main objective of this project is to present well-informed, relevant, and realistic alternative policy 
options to the European Parliament on silicone (breast) implants. The identification of these options has 
been based on a comprehensive, thorough, unbiased analysis of the scientific literature on the subject and 
of interested actors and parties, aiming to help in the European Parliament process so that more informed 
legislative and policy decisions on silicone can be made. 

Silicone implants are particularly complex due to the fact that they were used for years before there was 
regulation, study, or surveillance of their use and there are many different varieties and kinds of implants. 
Thus, and in spite of the relatively long period of empirical use, most epidemiological studies are fairly 
recent, beginning in the early 1990s. A great deal of attention and focus has been given to silicone breast 
implants since the early 90s, leading to many different studies and analyses that have driven to highly 
consistent results showing no evidence of a serious risk for major diseases. But it is also true that, because 
the studies started so recently, most have not been able to look at long-term effects, have mainly focused 
on cancer and well-known connective tissue diseases, were usually based on small sample sizes, and have 
not always controlled for the different types of implants. Thus, despite the fact that numerous studies have 
corroborated one another, pointing to inconclusive evidence of an association between silicone breast 
implants and cancer and connective diseases—the main two causes of concern—there are also some study 
limitations. This must be considered in light of the fact that a significant body of women claim to be 
experiencing symptoms which they think are associated with their implants. We have heard from women 
from self-help groups from the UK/Scotland, The Netherlands, Germany, Belgium, Switzerland, and 
Iceland (Silicone Support UK (SS/UK); Action Against Silicone Gel (AASG/UK); Silicone Information 
Network (SIN/UK); Stichting Steunpunt voor Vrouwen met (vragen over en/of problemen door) 
Siliconene borstprothesen (St. SVS/NL); German Support Group for Victims of Silicone Implants (GHG, 
DE); Selbsthilfegruppe Silikongeschadigter Frauen e. V. (SHG, BE), Silicone Support Switzerland 
(SS/Switzerland); Silicone Survivor Group, Iceland (SSG/Iceland), respectively). Without judging the 
epidemiological and clinical plausibility of the causality claimed in those complaints, we have been able to 
see that there are some clear areas for improving the guidelines and protocol for silicone breast 
implantation. 

In this context, we would like to stress that, in working on this project and, more specifically, in focusing 
on the project’s core—the development of alternative policy options—we encountered very strong 
viewpoints, and often conflicting information was received in our quest to be as clear, objective, thorough 
and unbiased as we possibly can. There are extremely strong interests at stake on either side of this issue, 
both of which may have valid, legitimate claims. Thus, our aim is to capture the complexity of the issue 
but try to get to its essence in a way in which the European Parliament can make the most appropriate 
decision in its regard.  

Option 1: status quo: no ban, keep application of current legal framework (namely, Directive 93/42/EEC, 
a general guiding directive which sets the basis without entering in further detail). 

Pros: good legislative basis in place, inconclusive evidence of serious risks, maintain stability. 

Cons: evidence points to need for proper European harmonisation aiming for increased and improved 
measures for further and better protecting women and women’s health in EC; self-help groups and others 
have called for an immediate ban 

Option 2: ban on silicone breast implants due to lack of complete information regarding risks and to 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

petitions by some groups. 

Silicone breast implants 

Pros: most conservative option—currently exercised, for example, by the US, Canada and France—due to 
lack of complete understanding and knowledge of risks because of short follow-up period of women and 
other complicating factors, such as variety of implants used, etc.; desired option by some groups/people 
(e.g., self-help groups of women suffering from adverse effects of silicone implants). 

Cons: large demands by women for these implants, especially considering some of problems with main 
alternative, saline implants—such as a higher risk of rupture, poorer appearance, etc. The available 
alternatives to silicone implants could even be worse and more studies are needed before promoting these 
alternatives. Also, studies on silicone-gel filled implants corroborate one another, pointing to inconclusive 
evidence of risks of serious health concerns, and pointing to local complications as main health concern, 
also present in alternative implants. Finally, from a social perspective related to health, there would also 
be the potential for economic damage to industry (e.g., job loss). 

Option 3: no complete ban, but the adoption and implementation of critical specific measures to increase 
and improve information for patients, tracking and surveillance, quality control and assurance and key 
research (see seven proposed measures below). 

Pros: studies do not point to an association between silicone implants and serious health risks, such as 
cancer and connective tissue diseases. Indicate that local complications—also just as prevalent or more so 
with other breast implants, such as saline—are the largest cause for concern. Information from self-help 
groups, surgeons and the literature points to a real need for improved measures, particularly regarding the 
provision of correct information to patients as to risks. Cons: need to make a real investment for co-
ordinated efforts and research investment to happen; self-help groups and others have called for an 
immediate ban.  

In view of the evidence, option 3, which proposes additional measures for maximising the benefits of 
breast implants and limiting the risks in the EU context, perhaps appears to be the most balanced 
approach. The further measures proposed are described as follows (and are elaborated on more in the full 
Options section of this report, section 3.1.):  

1.  To facilitate consensus on a breast implant consent form, including information related to alternatives, 

benefits and risks.  

2.  To guarantee marketing control over breast implants in order to avoid any kind of incorrect and 

misleading information.  

3.  To improve certification, technical standards and regulation. 
4.  To promote the elaboration of clinical guidelines, standards of care and the development of quality 

assurance systems. 

5.  To facilitate consensus, promotion and support of effective surveillance systems to report adverse 

effects and long-term effects.  

6.  To consider silicone breast implants a research priority and make funds available in the EU research 

programmes, specifically focusing on some of the shortcomings of research to date.  
7.  To foster tolerance and self-esteem and other conceptual alternatives to breast implants, in 

collaboration with active groups in this field. 

 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

2. Executive Summary 

Silicone breast implants 

The main objective of this project is to present well-informed, relevant, and realistic alternative policy 
options to the European Parliament on silicone (breast) implants. The identification of these options has 
been based on a comprehensive, thorough, unbiased analysis of the scientific literature on the subject and 
of interested actors and parties, aiming to help in the European Parliament process so that more informed 
legislative and policy decisions on silicone can be made. 

Silicone implants in general 
Silicone is used in implants located throughout almost every part of the body (for heart valves and other 
cardiovascular prostheses; for catheters in many parts of the body; in dentistry; in the gastrointestinal tract; 
in ophthalmology; in the ear, nose, throat, and respiratory tract; in the urogenital tract, including penile 
prostheses;  as a facilitator for nerve regeneration; as a prosthesis or ingredient in prostheses for many 
parts of the skeletal system; as a tissue expander; and as a cosmetic agent for treatment of scars and 
wrinkles). In this study, however, we will mainly focus on silicone implants in the breast. 

There is a large variety of breast implants on the market. Most of these implants have a silicone shell, 
although there are different kinds of fillings used in these implants (silicone-gel filled, saline, soybean oil, 
hydrogel). In addition, silicone-gel filled implants have experienced a number of changes since their 
introduction, and have undergone essentially three stages: a first generation, with a thick silicone shell and 
smooth consistency; a second one, with a thin silicone shell and smooth consistency, and a third 
generation, with a thick silicone shell and textured consistency. In this study, it should be noted that, from 
now on, whenever we refer to “silicone implants” we mean “silicone-gel filled implants,” the main focus 
of research on breast implants. 

Historical background 
Silicone breast implants were widely used in the United States (US) and Europe before there was any 
requirement for pre-market assessment of toxicity and complications. For many years, there were no 
requirements to document the composition of implants or the specific type of implant placed in a 
particular individual. Furthermore, there was no systematic, comprehensive, post-marketing surveillance 
of the long-term positive and negative consequences of silicone breast implants. Thus, until concerns 
about the health risks of silicone were raised in the 1980s, mainly in the US, and all breast implants were 
placed in a class III category (requiring strict standards for safety and effectiveness) by the US Food and 
Drugs Administration (FDA), the literature on silicone breast implants up until the early 1990s has not 
been very useful in assessing risk. 

In the course of the 1980s, increasing health concerns arose regarding breast implants, mainly focusing on 
silicone implants, due to suspicions that the gel leaks out to surrounding tissue, potentially causing cancer 
or connective diseases. In April 1991, in response to a number of adverse reaction reports that raised 
safety concerns about these implants, the FDA published a regulation that required manufacturers to 
submit pre-market approval applications with data showing the safety of the implants by July 9, 1991. The 
data submitted at that stage did not fully prove the devices safe, so the agency ordered the devices off the 
market in April 1992.  

The health concerns which surfaced in the US during the 1980s and 1990s extended to Europe, even 
though it is difficult to gauge the number of women with implants, and it appears to be much lower than 
in the US. In any event, in Europe, various studies were commissioned and conducted on the safety of 
silicone breast implants. In this context, the issues of safety and regulation of breast implants were 
discussed on several occasions between the Commission and Member States.  

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

Current context 
In the US, since 1992, silicone breast implants are only available for women with special medical needs 
who need breast reconstruction and who are willing to become part of a clinical trial approved by FDA. In 
early 1998, the FDA allowed the two existing manufacturers of silicone breast implants in the US (Mentor 
and McGhan) to conduct studies on women with silicone gel-filled implants who will be followed for 5 
years. Saline-filled implants have been allowed to remain on the market for all uses, although beginning in 
January 1993, the FDA requires manufacturers to submit regular data on safety and effectiveness and 
conduct clinical trials. It was believed that saline implants have a lower risk than gel-filled implants 
because leakage would only release salt water into the body. 

In Europe, different working groups were set up right after concerns were raised in the US. In general, 
these groups found no reason to ban silicone breast implants, although careful follow-up and studies were 
recommended within countries. In France, this issue was kept under discussion. Currently, all EU 
countries with the exception of France have no restrictions regarding availability of silicone breast 
implants and accept conformity with the Essential Requirements of the European Directive (93/42/EEC) 
as a basis for their marketing. This Directive requires manufacturers to conform with safety principles and 
eliminate risks as much as possible, to take adequate protection measures in relation to risks, and to inform 
users of existing risks. In addition, the device itself cannot put into jeopardy the clinical condition or the 
safety of patients or users, and any associated risks must be acceptable when weighed against the benefits. 
The required standards for ¨CE¨ marking of conformity are mainly related to technological standards, 
materials testing and biocompatibility assessment.  

In France, tighter restrictions apply, as silicone breast implants have been banned since 1992, and all 
implants other than saline have been prohibited since 1995. Surgeons must apply for and be granted 
exceptions in cases of special patient medical needs (e.g., reconstruction after mastectomy). In addition, 
surgeons are responsible for providing appropriate information to patients, and patients can hold their 
doctor liable for not fulfilling this right. 

Findings to date 

Silicone implants are particularly complex due to the fact that they were used for years before there was 
regulation, study, or surveillance of their use and because there are many different varieties and kinds of 
implants. Thus, and in spite of the relatively long period of use, most epidemiological studies are fairly 
recent, beginning in the early 1990s. A great deal of attention and focus has been given to silicone breast 
implants since the early 90s, leading to many different studies and analyses that have driven to highly 
consistent results showing no evidence of a serious risk for major diseases. But it is also true that, because 
the studies started so recently, most have not been able to look at long-term effects, have mainly focused 
on cancer and well-known connective tissue diseases, were usually based on small sample sizes, and have 
not always controlled for the different types of implants. This must be considered in light of the fact that a 
significant body of women, supported by some clinicians, claim to be experiencing symptoms which they 
think are associated with their implants.  

A summary of the literature on health risks follows: 

Systemic Effects 

Cancer 
There appear to be sufficiently consistent and convincing studies to support the conclusion of no 
association between breast cancer and implants, although research is currently being conducted to rule out 
the long-term risk. At the same time, the short average follow-up time of completed studies (and the still 
limited evidence in this field) does not allow us to conclude whether silicone breast implants are or are not 

 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

associated with other malignant neoplasms (other solid tumours, sarcoma, lymphoma, or myeloma), and 
the ongoing and future studies will hopefully shed light on these/ point. In the meantime, the available 
evidence does not support an association of silicone breast implants with other non breast cancers. 

Neurological disease 
Neurological symptoms or disease have been reported in some case series of women with breast implants. 
These findings are not consistent with other experimental and observational studies. Overall, it could be 
stated that the most properly designed and conducted epidemiological studies show no evidence that 
silicone implants cause neurological signs, symptoms or disease.  

Well-defined connective tissue diseases (related to autoimmune disorders) 
Recently published studies have indicated that women with silicone breast implants do not have a greatly 
increased risk of some well-defined autoimmune diseases (potentially fatal connective diseases), such as 
schleroderma, lupus erythematosus, rheumatoid arthritis, Sjogren´s syndrome, dermatomyositis or 
polymyositis, and health disorders such as fibromyalgia and ¨chronic fatigue syndrome.¨ 

Other systemic effects 
According to the information provided by self-help groups, some clinicians, and some additional sources, 
a substantial body of women with silicone implants have experienced these disorders, as well as a variety 
of symptoms that could be related to the immune system. These symptoms include pain and swelling of 
joints; tightness, redness or swelling of the skin; swollen glands or lymph nodes; unusual or unexplained 
fatigue; swelling of the hands and feet; excessive hair loss; memory problems; headaches; and muscle 
weakness or burning. In some cases, women have reported a reduction in symptoms after the implants 
were removed; in other cases, there was no change in symptoms after explantation. It is unclear at this 
time whether the signs and symptoms experienced by these women are related to their implants. 

In sum, the epidemiological literature has indicated that the evidence for an atypical disease or novel 
syndrome is insufficient and that there is no robust, convincing support for these disorders. However, the 
existence of a specific syndrome or syndromes in women with silicone breast implants cannot be 
completely proven or dismissed at this point in time, and deserves further analysis. 

¨Vertical¨ Effects (mother to child) 

Risks to infants 
At this time, there does not appear to be evidence of harmful effects to infants breastfed by women with 
silicone breast implants, although further study is needed in this area to shed further light on this area.  

Local Effects 

Local complications 
Studies points to local complications, including perioperative complications from the surgical procedure 
itself, as the largest potential health risk from silicone breast implants. The relatively high frequency of 
these complications is noticeable. While these are normally not life-threatening, they may result in 
discomfort, inconvenience, explantation, disfigurement, pain and other morbidities, and when further 
corrective procedures are necessary, an additional potential risk (e.g., additional surgery). Breast implants 
have a limited lifetime, which is not well-established. In any event, the probability of having a reoperation 
is high and it increases over time. 

In the US, a major class action litigation, brought on behalf of women with silicone breast implants, was 

Concerns by certain women’s groups 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

settled with a substantial award to the plaintiffs. Most importantly, assessment of the case points to the 
lack of appropriate warnings and information on potential risks by manufacturers.  

In Europe, in March 1999, two petitions were tabled by self-help groups of women who claim to have 
suffered adverse effects from implants calling for the European Parliament’s immediate ban on silicone 
implants. The EP is asking for formal replies and evidence to be submitted to the Petitions Committee, 
and has asked for counsel from the Committee on Women's Rights, the Committee on Public Health and 
Consumer Protection and the Committee on Research.  

Many women with silicone breast implants feel that they were not given sufficient information on the 
health risks to consent to have these implants. In the US, signing an informed consent form which 
explains all known and possible risks is now part of the required procedure for all women undergoing 
breast implant surgery. In Europe, all countries have general legislation or rules establishing the right of 
patients to be clearly informed of risks and benefits, although a common, fully accepted and standardised 
form does not yet exist. 

Potential benefits of breast implants and available alternatives 
There is a clear demand for breast implants by women, both from a cosmetic (augmentation) and 
reconstructive (reconstruction following mastectomy) standpoint. As a result, breast implants need to be 
considered also in light of their benefits. Reasons such as interest in improving self-confidence through 
the apparent improvement of self-image, a subjective sense of attractiveness and social relationships are 
the main apparent reasons for demanding cosmetic surgery. In addition, silicone breast implants must be 
compared with available alternatives. 

With the aim of reflecting all views on this issue (negative and positive), we have interviewed patients, 
and have contacted and received information from self-help groups, women’s groups, reconstructive 
surgeons, silicone breast implant manufacturers, countries, and scientific societies. We have incorporated 
this information and these positions into the report as best as we could, and have sent the Parliament 
original primary information in order to assess these materials firsthand. 

We would like to stress that, in working on this project, we encountered very strong viewpoints, and often 
conflicting information was received in our quest to be as clear, objective, thorough and unbiased as we 
possibly can. There are extremely strong interests at stake on either side of this issue, both of which may 
have valid, legitimate claims. Thus, our aim is to capture the complexity of the issue but try to get to its 
essence in a way in which the European Parliament can make the most appropriate decision in its regard. 

Operational, potential options  

Option 1: status quo: no ban, keep application of current legal framework (namely, Directive 93/42/EEC, 
a general guiding directive which sets the basis without entering in further detail). 

Pros: good legislative basis in place, inconclusive evidence of serious risks, maintain stability. 

Cons: evidence points to need for proper European harmonisation aiming for increased and improved 
measures for further and better protecting women and women’s health in EC; self-help groups and others 
have called for an immediate ban. 

Option 2: ban on silicone breast implants due to lack of complete information regarding risks and to 
petitions by some groups. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

Pros: most conservative option—currently exercised, for example, by the US, Canada and France—due to 
lack of complete understanding and knowledge of risks because of short follow-up period of women and 
other complicating factors, such as variety of implants used, etc.; desired option by some groups/people 
(e.g., self-help groups of women suffering from adverse effects of silicone implants). 

Cons: large demand by women for these implants, especially considering some of problems with main 
alternative, saline implants—such as a higher risk of rupture, poorer appearance, etc. The available 
alternatives to silicone implants could even be worse and more studies are needed before promoting these 
alternatives. Also, studies on silicone-gel filled implants corroborate one another, pointing to inconclusive 
evidence of risks of serious health concerns, and pointing to local complications as main health concern, 
also present in alternative implants. Finally, from a social perspective related to health, there would also 
be the potential for economic damage to industry (e.g., job loss). 

Option 3: no complete ban, but the adoption and implementation of critical specific measures to increase 
and improve information for patients, tracking and surveillance, quality control and assurance and key 
research (see seven proposed measures below). 

Pros: studies do not point to an association between silicone implants and serious health risks, such as 
cancer and connective tissue diseases. Indicate that local complications—also just as prevalent or more so 
with other breast implants, such as saline—are the largest cause for concern. Information from self-help 
groups, surgeons and the literature points to a real need for improved measures, particularly regarding the 
provision of correct information to patients as to risks.  

Cons: need to make a real investment for co-ordinated efforts and research investment to happen; self-help 
groups and others have called for an immediate ban.  

In view of the evidence, option 3, which proposes additional measures for maximising the benefits of 
breast implants and limiting the risks in the EU context, perhaps appears to be the most balanced 
approach. The further measures proposed are described as follows (and are elaborated on more in the full 
Options section of this report, section 3.1.):  

1. 

 To facilitate consensus on a breast implant consent form, including information related to 
alternatives, benefits and risks.  

2.  To guarantee marketing control over breast implants in order to avoid any kind of incorrect 

and misleading information.  

3.  To improve certification, technical standards and regulation. 
4.  To promote the elaboration of clinical guidelines, standards of care and the development of 

quality assurance systems. 

5.  To facilitate consensus, promotion and support of effective surveillance systems to report 

adverse effects and long-term effects.  

6.  To consider silicone breast implants a research priority and make funds available in the EU 

research programmes, specifically focusing on some of the shortcomings of research to date.  

7.  To foster tolerance and self-esteem and other conceptual alternatives to breast implants, in 

collaboration with active groups in this field. 

In summary, the option consisting of no complete ban, but the adoption and implementation of critical 
specific measures to increase and improve information for patients, tracking and surveillance, clinical 
guidelines, quality control and assurance and key research could be reasonably consistent with the 
philosophy underlying the criteria of the European precautionary principles and perhaps is the most 
balanced alternative after weighing the existing evidence. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

3. Final Study 

Silicone breast implants 

3.1. Options 
3.1.1. Background information for relevant European options 

3.1.1.1. Options for implant devices. Foreseeable market forces and social dynamics for silicone implants 
diffusion and control 

Background and principles 

The development of innovative technologies and the growing need for harmonising the European political 
context have drawn increased attention to the regulatory environment of new medical devices. New 
technologies may offer potential benefits in terms of health gain or the relief of suffering, but there may 
also be some risks to health, social or economic costs, or ethical issues of concern. It would seem sensible 
to state that safeguards must exist in order to prevent the adoption of potentially harmful technologies, 
while permitting innovation and accessibility to new effective medical devices aimed at satisfying the 
demands and needs of the European population. 

Types of implants 

There is an enormous diversity of breast implants on the market. Hundreds of different types have been 
marketed and used. Variations affect the shell, filling materials, number of lumens (cavities), size, shape, 
type of intervention, and other characteristics. A great number of changes in silicone breast implants have 
been made since they were introduced in 1962. These changes represent additional difficulties when 
assessing the health effects of breast implants. In addition, modifications were introduced with little or no 
pre-testing for biological or clinical effects. Varying control of the diffusion of silicone fluid through gel 
implant shells, shell strength, and therefore durability of both gel- and saline-filled implants, as well as 
polyurethane coating, were among the changes which affected the clinical performance of silicone breast 
implants in ways that, in many instances, were not predicted. Modifications have been made aimed to 
improve implants, as plastic surgeons and manufacturers have learned of problems with existing implant 
models. Barrier shells, texturing, better valves in saline implants, and stronger shells that are more 
resistant to rupture or deflation have been some of these changes. For example, polyurethane coating of 
breast implants, lipid (new soybean oil-filled) or polymer breast implants, expandable prosthesis and other 
implant types have been developed with this objective.  

In fact, since the beginning of commercial manufacturing of silicone breast implants in the 1960s, there 
have been three generations of implants filled with silicone gel. The first generation implants were made 
with a thick silicone-gel and thick shell (smooth surface). These implants present a low rupture rates, and 
a high rate of gel bleed and capsular contracture. The second generation, used from mid-1970s to the late 
1980s, were made with a thin silicone shell (smooth), and presented a high rate of gel bleed and rupture. 
The third generation, manufactured since the mid-1980s, have a thick silicone shell (textured) and 
presumably present a lower rate of gel bleed, rupture and capsular contracture, but a larger, closer follow-
up is needed before a definite statement on this can be made.  

There are other kinds of breast implants. As mentioned, for example, there are polyurethane-coated 
implants, which have a coating intended to reduce the risk of contracture. Concerns with this material, 
which surfaced through realisation that it could cause cancer in animals when broken down, led to a recent 
study in women. Findings from this study indicate that there are no increased risks of cancer in women 
from polyurethane. Increased risks of cancer in nursing infants have not been completely ruled out, 
although the lack of increased risk found in women is reassuring. 

While the majority of breast implants contain a silicone shell, there are also different kinds of fillings used 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

in these implants (silicone-gel filled, saline, soybean oil, hydrogel). Both silicone-gel (the main focus of 
this study) and saline have been mentioned earlier, but a trilucent implant also exists (made with purified 
soybean oil). In the US, women were enrolled in a clinical study to assess this implant’s safety, and 
currently, FDA is analysing results. In the UK, this implant was banned in 1999 due to some reported 
problems and a lack of information regarding its long-term effects. Finally, hydrogel implants exist on the 
market. 

Some pros and cons of different types of breast implants can be found below: 
Silicone: Pros: long experience on use, relatively low rupture rate, better appearance and feel, usually 
stays in capsule if ruptures; Cons: concerns and potentially negative perception of silicone and its safety, 
some clinicians and groups of women claiming adverse symptoms associated with silicone. 

Saline: Pros: physiological, no swelling or shrinking, rupture taken up by body itself; Cons: higher 
rupture/deflation rate than silicone, increased likelihood of shell folding, prone to weakening—look much 
worse, associated with noise (can actually sometimes hear saline solution).  

Trilucent/purified soybean oil: Pros: soybean oil, perceived safer, Cons: reports of some swelling, pain, 
short experience of use and not enough information on safety, pending data. 

Hydrogel: Pros: more consistent than saline, natural materials, so “perceived” to be safe; Cons: not 
isotonic; takes up water and can swell up to point of rupture, safety not established/some toxicity not ruled 
out, no long-term studies. 

Autogenous tissue: mainly used in breast reconstruction. Such reconstruction are often combined with 
implants. Dermis flaps or dermis-fat-fascia grafts, musculocutaneous flat from the abdomen or from other 
sites, and microsurgical free flats have been used. Pros: safe, generally good results: Cons: use cautiously, 
problems depending the origin of tissue. 

Manufacturers of breast implants 

Manufacturers of breast implants are mainly US multinational companies, but there is also a clear 
European component in this business. Silicone and saline implants are produced by big companies such as 
McGhan and Mentor Corporation. Hutchinson International and Poly Implants Prostheses also produce 
saline filled implants. Many manufactures import breast implants to the EU countries. Other companies 
which are or have been manufacturers of breast implants in the EU include: Polytech/Silimed and 
Novamed located in Germany; Nagor and Jutchinson in the UK; Poly Implant Protheses, Laboratories 
Eurosilicone, Sebbin, and Arion located in France; and Biomedica Sviluppo and Impax Diffusion in Italy. 
EUCOMED is an “umbrella” organisation representing the main companies of this sector and their 
interests in Europe. 

Demand for implants 

As for the social dynamics for silicone implants, it is important to stress the large demand for breast 
implants, both for cosmetic and reconstructive purposes, in the industrialised world. According to 
references in the US from 1997, approximately 70% of breast implants were performed for augmentation 
and 30% for reconstruction. Demand for breast implants has been present since the 1960s, and has 
continued growing. Recently, demand for implants has been growing for men (i.e., sex change surgery) as 
well as for women. 

Relevant and definite benefits in terms of health and quality of life seem to be substantial for many 
women and men demanding cosmetic breast surgery. Although reasons for obtaining breast implants are 
not very well studied, interest in improving self-confidence through the apparent improvement of self-

 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

image, a subjective sense of attractiveness and social relationships are the main apparent reasons for 
demanding cosmetic surgery. Breast implants appear to be an effective procedure for satisfying these 
demands.  

Satisfaction 

The majority of reports on satisfaction present very good results, but two things should be kept in mind. 
First, satisfaction is a very subjective dimension. It is also true that many published reports of satisfaction 
have obvious limitations. They are frequently carried out without a solid design and often by plastic 
surgeons, which could lead to incomplete or even biased reports. In addition, they usually report on an 
unspecified or very short postoperative interval. Other possible biases or distortions of patients’ responses 
are the small number or non representative women who are interviewed, the voluntary nature of the 
surveys and the use of overall satisfaction in general terms as a main outcome. Women have shown 
considerable tolerance for contracture, either by not seeking medical attention for serious contracture 
(class III or IV) or by pronouncing themselves satisfied with their implants when surveyed. A 1990 study 
reported that 85% of women appeared satisfied with their implants even though 35% had experienced 
severe contracture (Gylbert LO, et al., 1990). Studies present a range of general satisfaction from 80% to 
95%. A survey carried out by plastic surgeons in the U.S. reported that 84% of women with implants for 
augmentation and 91% for reconstruction were satisfied to very satisfied at least one to ten years from 
operation (Park AJ,et al., 1996).  

On the other hand, national U.S. data on satisfaction and adverse effects (from 1984 through 1995) shows 
notification of 94,120 adverse events, the majority of which were local and perioperative complications 
(contracture and rupture). The number of adverse experiences peaked in 1992-1994 and decreased 
markedly in 1995. 

For the sake of gathering primary data for this report, as requested at the Scoping Meeting (held at the 
European Parliament for the sake of specifying the objectives of this project), we have interviewed breast 
implant patients to gauge their views and degree of satisfaction with their implants. We succeeded in 
identifying women who were willing to talk with us and be interviewed. We would like to underline both 
that the sampling approach is not, of course, methodologically generalizable (due to the fact that women 
were selected by word of mouth) and the numbers are small, but, in spite of this, we believe that this 
anecdotal information is interesting to consider and points to high levels of satisfaction (see Annex A for 
the patient questionnaire and compilation of results). We were also able to directly experience the 
complexity and difficulty of this appraisal exercise, due to the inherent personal nature of implants and 
individuals’ sense of privacy. At the same time, a selection bias may occur when only certain women are 
willing to provide their views on satisfaction. That is why we have directly witnessed some limitations of 
the direct interviews commonly used as indicators of satisfaction. 

It seems logical to state that the existence of potential risks associated with the intervention must be 
weighed against the potential benefits perceived by women. Women’s appreciation of good results have 
sustained the demand for breast implants.  

Along with these demands, however, there have been increasing concerns and have been definite 
problems, made particularly acute through attention to this issue in the US over the course of the last 
decade. This concerns have spilled over to Europe. This is explained in the next section, 3.1.1.2. 

3.1.1.2. Summary of European and international efforts and investments in this field 

It is difficult to understand the background around European efforts in this field without understanding the 
corresponding background in the US. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

The US experience 

In the US, the Medical Device Amendments were enacted in 1976, giving FDA the authority to regulate 
medical devices such as breast implants, which had already been on the market since the 1960s.  

FDA has three regulatory categories for medical devices. Class I and class II are for devices whose safety 
and effectiveness are well-established. Class I devices are simple devices whose risks can be controlled by 
the manufacturing process; class II devices require additional measures, called special controls, to control 
risks. Special controls may include performance standards, post-market surveillance studies, user 
education or other measures. If there is a lack of information about what makes a device safe and 
effective, it is put into class III, the highest level of pre-market review is required. Class III devices 
include innovative, medical breakthrough and new technology devices, as well as devices with poorly 
established or questionable safety and effectiveness. 

A short review of regulation by the Food and Drug Administration (FDA) explains why current breast 
implantation is primarily with saline-filled implants, and describes the effects of government actions on 
gel-filled, polyurethane-coated, and other implants and on the companies that manufactured them. 

In 1976, the FDA General and Plastic Surgery Devices Panel (referred to as the Panel) recommended that 
breast implants be placed in class II, requiring general controls and performance standards. On January 
19, 1982, because of some reports of adverse events in the medical literature, the FDA announced a 
proposal to place breast implants in class III, with the most stringent controls for safety and effectiveness.  

In 1988, the FDA classified all breast implants into class III. After a prescribed waiting period of 30 
months, the FDA could require the submission of pre-market approval applications (PMAs) in which 
manufacturers present data showing the safety and effectiveness of these devices. In April 1991, in 
response to a growing number of adverse reaction reports that raised safety concerns about the silicone 
gel-filled implants, the FDA published a regulation that required manufacturers to submit pre-market 
approval applications with data showing the safety and effectiveness of the implants by July 9, 1991. The 
data submitted did not fully prove the devices safe, as required by law, so the agency order the devices off 
the market in April 1992 and restricted their use to clinical trials studies for reconstruction after 
mastectomy, correction of congenital deformities, or replacement for ruptured silicone gel-filled implants 
for augmentation. FDA denied applications for using silicone breast implants for augmentation but 
planned that the manufacturers would later conduct clinical trials that would include a limited number of 
augmentation patients (the stage 3 or core studies).  

On June 5, 1998, FDA approved McGhan’s medical IDE study for silicone gel-filled breast implants for 
augmentation, reconstruction, and revision for a set number of patients at a limited number of sites. 
Mentor Corporation’s adjunct study was also approved by FDA. Silicone gel filled breast implants and 
alternative breast implants also may be available to women who participate in Investigational Device 
Exemptions (IDE) studies.  

Regarding saline breast implants, although still on the market in the US, on December 23, 1994, FDA 
announced that companies marketing these implants are required to enrol patients in clinical trials and 
conduct laboratory and clinical studies to determine the safety and effectiveness of these implants. Since 
this time, manufacturers have had to submit data to the FDA under a pre-market approval application 
(PMA). Currently, FDA is evaluating data submitted by manufacturers on these implants and the law 
requires that, based on the data, FDA will have to approve the applications in order for companies to 
continue selling saline implants. A meeting on saline PMAs was held from 1-3 March 2000, and the FDA 
Advisory Committee recommended approval of Mentor and McGhan saline implants, although the FDA 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

has not yet made a decision in this regard (we have been informed that it will be made before the end of 
May). 

A major class action litigation brought on behalf of women with silicone breast implants was settled with 
a substantial award to the plantiffs. Assessment of the case, most importantly, points to the lack of 
appropriate warnings and information on potential and real risks by manufacturers. This case spurred the 
court’s request to a panel of experts for a report on specific issues concerning health consequences of 
silicone breast implants. Thus, a report by the National Science Panel (NSP) (four experts on toxicology, 
immunology, epidemiology and rheumatology) was presented in 1998 to the Honourable S.C. Pointer, 
Judge for the Federal Breast Implant Multi-District Litigation. This report reviewed the scientific literature 
related to silicone breast implants and connective tissue diseases and immunological dysfunction. 

In 1999, the Institute of Medicine (IOM) of the National Academy of Sciences completed a 
comprehensive evaluation of the evidence associating silicone breast implants with human health 
conditions, commissioned by the US Department of Health and Human Services. They objective of the 
study was to conduct an independent, unbiased review of all past and ongoing scientific research 
regarding the safety of silicone breast implants. With this aim, a committee of experts in relevant scientific 
and clinical areas evaluated past and ongoing studies of the relationship, if any, between implants and 
systemic disease; assessed the biologic and immunologic effects of silicone and other chemical 
components of breast implant; and assessed the impact of breast implants, if any, on the offspring of 
women with implants or the accuracy of mammograms.  

Both the NSP and IOM studies found no evidence of an association between silicone breast implants and 
increased risks of cancer or connective tissue diseases, the main two original causes of concern. Results of 
these (and other) studies are discussed in depth in 3.2. Arguments and Evidence. 

According to the IOM study, an estimate of between 1.5 million to 1.8 million U.S. women have breast 
implants. About 70% of these implants were performed for augmentation, (i.e. enlarging or changing the 
appearance of the breast), and 30% for reconstruction, (i.e., restoring the form of the breast after 
mastectomy for cancer, fibrocystic disease, or other medical needs). In 1998 alone, data provided by the 
American Society of Plastic Surgeons show a total of 132,378 interventions for breast augmentation (97% 
saline-filled and 3% gel-filled, 61% in women under 35 years old) and 69,683 interventions for breast 
reconstruction (75% saline-filled and 15% gel-filled, 94% in women over 35 years old). At the same time, 
43,681 breast explantations (implant removals) were made, mainly (93%) due to physical symptoms 
related to these implants, such as capsular contracture. Breast cosmetic and reconstructive surgery 
represents more than 10% of total plastic surgery interventions. From 1992 to 1998, a large increase in 
these interventions was observed: breast augmentation (306%), breast reconstruction (135%), breast 
explantation (76%). In addition to this, more than 10 million persons in the United States have some type 
of implant, such as finger joints or pacemakers, and many of these implants are made, at least in part, from 
silicone.  

The FDA is currently conducting a study to assess the rupture rate of silicone gel-filled breast implants. 
This study will include more than 1200 women, and medical records will be sought if their breast implants 
have not stayed intact. A sub-group of women who still have their implants will receive an MRI to 
determine if the implants are intact. This study began in early 1998, and is currently underway.  

As a result of the growing concern in the US during the 1980s, focus was drawn to possible health risks 
posed by breast implants in Europe. A variety of study groups and research initiatives were developed to 
address these concerns. A comprehensive review of these toxicology studies of silicone and other studies 

The European experience 

 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

does not provide a basis for an association between silicone implants and major health risks. However, the 
large need for additional surgical corrective procedures and frequent local and perioperative complications 
are important causes for concern. Risks accumulate over the lifetime of the implant, but quantitative data 
on this for modern implants are lacking and are deficient historically. Due to health risks, particularly 
concerning the nature and the relatively high frequency of local complications and additional operations, 
the need for proper informed consent (with complete, adequate information) has become an essential 
element of the process for women undergoing breast implantation. It also needs to be kept in mind that, in 
spite of inconclusive evidence of a clear health risk associated with silicone breast implants, a substantial 
body of women with these implants who are experiencing similar inexplicable symptoms have formed 
self-help groups across Europe. We have received information and materials from self-help groups in the 
UK/Scotland, the Netherlands, Germany, Belgium, Switzerland and Iceland. Two of these groups have 
requested an immediate ban of these devices (see European Parliament, News Report 22-03-99 and Annex 
B for original materials and information from self-help groups). This position also deserves proper 
consideration, and, together with the intrinsic complexity of completely ruling out any hazard associated 
with these implants, explain why this issue is still a concern. 

It is extremely difficult to know the exact number of implants in women in the EU, and we have to rely on 
available data in only some countries, such as the UK, which has developed a breast implant registry. For 
example, during 1996-1997, breast implants registered (12.829) in the UK correspond to silicone gel 
(80%), saline (2%) lipid or polymer (12%) and other (6%). Most of the women had breast implants for 
augmentation or other cosmetic reasons (70-80%). In many countries, however, the absence of a registry 
and a compulsory system for notification makes it very difficult to know the frequency of local 
complications. These are just some limitations we have to recognise when examining the background of 
this issue.  

At the same time, however, progress has been made by scientific societies and others with regard clinical 
guidelines, quality standards, and other key elements, such as informed consent, for providing better 
options to women seeking breast implants. 

Various research and review efforts have been carried out in Europe, such as the report published in 
France by ANDEM (1996), and the comprehensive overview carried out by the Independent Review 
Group in the UK (1998). Other observational research initiatives, including a population-based follow-up 
study in Denmark (1998) and a retrospective cohort study in Sweden (1998) have also been conducted. 

Regarding efforts to clarify issues of safety and appropriate certification of breast implants in Europe, this 
issue has been given careful attention and has led to different interchanges and discussions between the 
Commission and Member States. This process has driven different options currently adopted by Member 
States in Europe, with the exception of France, which does not share the existing Essential Requirements 
of the European Directive. Council Directive 93/42/EEC of 14 June 1993 is the current cornerstone in this 
field (see 3.1.1.4.). 

In the UK, the Medical Devices Agency (MDA) set up an Independent Expert Advisory Group and 
published a review analysis in 1992, updated in 1994. A National Breast Implant Registry was established 
in 1993. Further details are given in 3.1.1.4. 

In Spain, a working group of independent experts reviewed the existing evidence and arrived at the 
conclusion of proposing implant and explant registries. We have been informed that within the next 
months, the first analyses of data arising from these registries will be available. 

As for technological investments and efforts, new developments in breast implant technology may change 

 
 
 
 
 
 
 
 
 
 
  
 
 
 
Final report for STOA 

Silicone breast implants 

the horizon, but they need to be considered and assessed with caution. Cohesive silicone gel represents an 
innovation. A new hydrogel formulation of polyvinylpirrolidone (PVP) device for breast implants has 
been tested and used in Europe. Also, new saline-filled implants that are pre-filled rather than being filled 
at the time of surgery with sterile saltwater solution could eliminate valve leakage and improve sterility. In 
short, these innovations may provide increased options for women seeking breast enlargement or 
reconstruction, but they need further review and attention.  

3.1.1.3. Review of European legislation 
3.1.1.3.1. Directives related to implants/medical devices 
Breast implants are regulated by Council Directive 93/42/EEC of 14 June 1993 concerning medical 
devices.  

As a general rule in Europe, all medical devices are required to carry the "CE" marking denoting a 
European conformity standard. The "CE" mark permits the product to be marketed in the EC, although it 
does not guarantee its complete safety. It is important to keep in mind the difficulty of ensuring the 
complete absence of risk in all circumstances. According to the European “CE” marking Directive, the 
devices must meet the essential requirements set out in the Annex I of the Directive, taking into account 
the intended purpose of the device. The device cannot put into undue danger the clinical condition or the 
safety of patients, or the safety or health of users or, where applicable, other persons. In addition, any risks 
which may be associated with their use must constitute acceptable risks when weighed against the benefits 
to the patient. The manufacturers must conform to safety principles and eliminate or reduce risks as much 
as possible, take adequate protection measures in relation to risks, and inform users of the existing risks. 
During the lifetime of the device as indicated by the manufacturer, its characteristics and performance 
must not be adversely affected to such a degree that the clinical conditions and safety of the patients are 
jeopardised. 

Regarding design and chemical, physical and biological properties of the device, particular attention must 
be paid to the choice of materials used (toxicity) and the compatibility between the materials used and 
biological tissues, cells and body fluids. 

The required standards for "CE" marking of conformity are mainly related to technological standards, 
materials testing and biocompatibility assessment. Long-term effects of the implants, including adverse 
effects, must be assessed through a post- marketing surveillance system, the competence and responsibility 
of each Member State, which is usually organised as a voluntary system of reporting incidents, unwanted 
side effects, failures, etc.  

Conformity with the Essential Requirements for safety and performance may be demonstrated by 
compliance with authorised standards. Relevant European standards for breast implants include generic 
standards for risk analysis (EN 1441), non-active implant standards (EN ISO 14630), sterilisation, 
biological safety and other specific requirements for mammary implants (EN 12180, recently approved). 
The different safety-related features of breast implants, including biocompatibility, mechanical properties, 
migration of the filling and shell material, compatibility between shell and filling material, ageing, 
stability and labelling are currently under examination within the European committee for standardisation 
(CEN) and within a special working party of certification bodies in charge of these products on the basis 
of Directive 93/42/EEC.  

There is systematic classification of the different medical devices. Specifically, breast implants are 
considered non-active implantable medical devices. Thus, as all other implantable devices and long-term 
surgically invasive devices, breast implants have been classified according to risk and have been placed 
into Class IIb. This class constitutes a high risk potential. Inspection by a notified body is required 

 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

regarding the design and manufacturing of the devices. 

Silicone breast implants 

In the case of devices falling within Class IIb, the manufacturers shall, in order to affix the CE marking, 
either: 

a) follow the procedure relating to the EC declaration of conformity (full quality assurance). 

Manufactures must ensure application of the quality system approved for the design, manufacture 
and final inspection of the products concerned, and are subject to audit and community 
surveillance. 

b) follow the procedure relating to the EC type-examination, coupled with the procedure relating to the 
EC verification or to the EC declaration of conformity (production quality assurance) or to the EC 
declaration of conformity (product quality assurance). 

The Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and 
administrative provisions of the Member States concerning liability for defective products also affects 
liability of the producers of silicone implants. 

3.1.1.3.2. Directives related to consumer protection 
The necessity to guarantee the safety and to protect the health of consumers is a priority of the European 
Union and of the Member States.  

Community action as regards consumers' protection is based on article 129A of the Treaty of the European 
Union which establishes that the European Union will contribute to a high level of the consumers' 
protection by means of:  

-Measures adopted according to article 100 A. 
-Support and complementary actions to those developed by the Member States in order to protect 
the health, safety and economic interests of consumers, and to guarantee the population 
appropriate information. 

The number of directives in this sector is very high. Most of those related with health refer to the safety 
and control of foods (substances with hormonal effects, additives, labelling, special feeding) and general 
safety of consumption products.  

The production, marketing, classification , labelling, promotion, and procedures of authorisation of 
medications and medical devices have also been subject to European directives.  

3.1.1.3.3. Other relevant legislative references 

The Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to 
active implantable medical devices (90/385/EEC) is the only additional legislative reference related to 
implants, but—in fact—it is not of direct applicability to breast implants as it only refers to “active 
medical devices” (those devices which function from a source of electrical energy or any source of power 
other than that directly generated by the human body or gravity). 

3.1.1.4. Consultation with EU Member States, current situation of implants distribution and use, 
government position, legislative and health policies adopted  

All EU Member States (except France) have no restrictions on the use of silicone-gel breast implants. 
Thus, there is no specific legislation on silicone implants and most of these countries have not considered 
or planned any, apart from conformity with and the application of Medical Device Directive (93/42/EEC). 
All these countries have general legislation or rules establishing the responsibility for providing 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

information and the right of patients to be clearly informed of risks and benefits before undertaking any 
kind of surgery. Some countries have implemented specific regulations on information regarding breast 
implants, through guidelines directed to patients and surgeons. In addition, National Scientific and 
Professionals Societies related to breast and cosmetic surgery and also the European Committee on 
Quality Assurance and Medical Devices in Plastic Surgery (EQUAM) have proposed specific informed 
consent forms and provide information on risks and benefits to the patients. 

In the European context, the issues of safety and of certification of breast implants were discussed on 
several occasions between the Commission and Member States. Excluding France, all EU countries accept 
demonstration of conformity with the Essential Requirements of the European Directive (93/42/EEC) as a 
basis for the marketing of silicone breast implants. In the United Kingdom and France, recent scientific 
literature on risks related to silicone gel-filled breast implants was reviewed in 1996 and 1994 by 
independent scientific experts, and different options have been adopted by these Member States. These 
cases are explained below. 

In the UK, the Medical Devices Directorate of the Department of Health reviewed the evidence for links 
between silicone gel breast implants and connective tissue diseases in 1991. Later, the new Medical 
Devices Agency (MDA) set up an Independent Expert Advisory Group and published a review analysis in 
1992, updated in 1994. A National Breast Implant Registry was established in 1993. Since then, the MDA 
has produced several reports concerning silicone and trilucent (soybean-oil) breast implants. In 1998, an 
Independent Review Group (IRG) published a new report at the request of the Minister of Health, 
reviewing all the evidence related to the possible health risks associated with silicone breast implants and 
issues concerning pre-operative patient information. In March 1999, the MDA and the Department of 
Health decided to withdraw trilucent and oil-breast implants as a precautionary measure, after receiving 
reports of local complications (swelling associated with implant rupture) in a small number of women. 
Silicone-gel filled breast implants are available without any restriction. 

In France, since 1992, silicone breast implants have been restricted. In 1995, all breast implants except 
saline-filled implants were banned. Surgeons must apply for exemptions in the case of specific medical 
needs (reconstruction after mastectomy and other) for silicone implants. The ban has been renewed every 
year. The ANDEM report (1996) was basically consistent with the conclusions and recommendations 
made later by IOM (USA) and the UK Independent Review Group, considering the surgical and implant 
contracture or rupture risks as the main health problems. However, and due to precautionary measures, 
ANDEM asked for restrictive criteria (toxicology and clinical) to authorise the marketing of breast 
implants under the European existing Directive (93/42/EEC). In 1996, The French Ministry of Health 
issued a decree in which breast implants were considered at high risk of rupture and subsequent serious 
adverse effects. Silicone gel breast implants need to be tested to confirm their conformity with strict 
standards and safety requirements. The European Commission set up a Project Group to develop uniform 
guidance for the conformity assessment of breast implants according to the Directive. The technical 
specifications to confirm their conformity with Essential Requirement for Safety and Performance were 
reported back to the EC, and a new French report establishing technical recommendations for marketing 
was also appended. The process is still ongoing at this time.  

In Spain, a working group, including experts in medical devices, oncology, rheumatology, plastic surgery, 
immunology and other related fields, concluded that there was no reason for a moratorium on silicone 
implants from existing evidence. Registries for implants and explants have been developed and periodic 
health controls are conducted. 

In addition to having reviewed secondary sources of legislative information about the position of EU 
Member States on this issue, we have also sent formal letters to the responsible authority on health 

 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

products in each EU country, not only to request information on the latest potential regulation, but also on 
Member States’ views about the need for developing a common European position on silicone implants 
(see Annex A for letter and responses). 

3.1.1.5. Review of other relevant references related to international legislation 

A review of legislation in the US has been comprehensively covered in section 3.1.1.2. 

In Canada, a moratorium on the marketing and use of silicone -gel filled breast implants was passed in 
1992. Saline-filled breast implants are available. The Canadian Department of National Health and 
Welfare also set up an Independent Advisory Committee to review the health problems posed by gel-filled 
breast implants. In 1992, this Committee reported the insufficient evidence of autoimmune disease 
associated with silicone breast implants and recognised the absence of more accurate data on local 
complications and the need for additional research. The Canadian Society of Plastic Surgeons made recent 
recommendations to provide information on breast augmentation to patients well in advance, and to 
thoroughly discuss the risks (surgery, contracture, rupture, limited lifespan) and benefits associated with 
this procedure. A doctrine of informed consent is well established in Canada and has been reinforced with 
the case of Hollis versus Dow Corning decided by the Supreme Court of Canada. 

In Australia, silicone implants are available by special application from the Therapeutic Goods 
Administration (TGA) in Canberra, the regulatory authority, although saline filled implants are available 
without any such authority. The country does not have any approval for other types of implants, such as 
soybean oil. A detailed Breast Enlargement Guide for Women has been produced by the Australian 
Society of Plastic Surgeons. 

(See Annex for sample letter sent to Scientific societies across the world and responses). 

3.1.1.6. EU instruments related to harmonisation of legislation, and medical device control 

In general, there is a good EU legislative basis for future developments in this field. It is important, as it 
covers many of the regulations adopted by Member States and has been a reference point for the 
approximation of national laws and regulations. Under current legislation, many new measures could be 
developed. The main EU directives, and those more specifically related with medical devices, are below: 

•  Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision of 

information in the field of technical standards and regulations. 

•  Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and 
administrative provisions of the Member States concerning liability for defective products. 

•  Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States 

relating to electromagnetic compatibility. 

•  Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member 

States relating to active implantable medical devices. 

•  Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, which is the current 

cornerstone in this area. 

3.1.2. Operational, potential options, including alternative approaches for new European Directives 

In working on this project and, more specifically, focusing on the project´s core: development of 
alternative policy options, we would like to stress the difficulties encountered by our team through the 

 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
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Silicone breast implants 

very strong viewpoints and often conflicting information we received in our quest to be as clear, objective, 
thorough and unbiased as we possibly can. There are extremely strong interests at stake on both sides of 
this issue which may have valid, legitimate claims. We aim to capture the complexity of the issue but get 
to its essence in a way in which the European Parliament can make the most appropriate decision possible 
in its regard. 

Option 1: status quo: no ban, keep application of current legal framework (namely, Directive 93/42/EEC, 
a general guiding directive which sets the basis without entering in further detail). 

Pros: good legislative basis in place, inconclusive evidence of serious risks, maintain stability. 

Cons: evidence points to need for proper European harmonisation aiming for increased and improved 
measures for further and better protecting women and women’s health in EC; self-help groups and others 
have called for an immediate ban 

Option 2: ban on silicone breast implants due to lack of complete information regarding risks and to 
petitions by some groups. 

Pros: most conservative option—currently exercised, for example, by the US, Canada and France—due to 
lack of complete understanding and knowledge of risks because of short follow-up period of women and 
other complicating factors, such as variety of implants used, etc.; desired option by some groups/people 
(e.g., self-help groups of women suffering from adverse effects of silicone implants). 

Cons: large demands by women for these implants, especially considering some of problems with main 
alternative, saline implants—such as a higher risk of rupture, poorer appearance, etc. The available 
alternatives to silicone implants could even be worse and more studies are needed before promoting these 
alternatives. Also, studies on silicone-gel filled implants corroborate one another, pointing to inconclusive 
evidence of risks of serious health concerns, and pointing to local complications as main health concern, 
also present in alternative implants. Finally, from a social perspective related to health, there would also 
be the potential for economic damage to industry (e.g., job loss). 

Option 3: no complete ban, but the adoption and implementation of critical specific measures to increase 
and improve information for patients, tracking and surveillance, quality control and assurance and key 
research (see seven proposed measures below). 

Pros: studies do not point to an association between silicone implants and serious health risks, such as 
cancer and connective tissue diseases. Indicate that local complications—also just as prevalent or more so 
with other breast implants, such as saline—are the largest cause for concern. Information from self-help 
groups, surgeons and the literature points to a real need for improved measures, particularly regarding the 
provision of correct information to patients as to real and potential risks. 

Cons: need to make a real investment for co-ordinated efforts and research investment to happen; self-help 
groups and others have called for an immediate ban.  

Health and other benefits of cosmetic treatments are not easily estimated or measured, and are not usually 
considered when risks and effectiveness of these interventions are assessed. However, the demand for 
breast implants and other cosmetic interventions is increasing, and women’s reasons for obtaining breast 
implants are not very well studied. The existence of risks associated with the intervention must be 
weighed against the benefits perceived by women. Regulation affects the breast implants market in 
Europe, and it should be aimed at guaranteeing reasonable safety and assuring that any undesirable side-

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Silicone breast implants 

effect constitutes an acceptable risk when weighed against the intended purpose.  

In view of the evidence, option 3, which proposes additional measures for maximising the benefits of 
breast implants and limiting the risks in the EU context, perhaps appears to be the most balanced 
approach. The further measures proposed are described as follows:  

1. To facilitate consensus on a breast implant consent form, including information related 
to alternatives, benefits and risks. The lack of appropriate information on risks and benefits has 
been underlined as a major problem surrounding the issue of silicone breast implants on all fronts 
(e.g. this has been cited by the scientific literature, such as the IOM report, by self-help groups, by 
surgeons, etc.). 

A standardised consent form should be developed, including risks inherent in surgery, local 
complications, the realistic lifetime of implants and need for replacement, the incidence of post-
operative and long-term complications, other potential health hazards, etc. Many good models of 
informed consent on this issue exist which could be used as a basis for a standardised informed 
consent form for Europe. In addition, it should be stressed in the form that women need to have 
time to reconsider surgery after reading it. 

2. To guarantee marketing control over breast implants in order to avoid any kind of 
incorrect and misleading information.  
A great deal of misinformation exists around silicone breast implants in both favourable and 
unfavourable directions. This measure focuses on facilitating access to reliable information about 
risks and benefits of breast implants, and on imposing tighter controls on misleading information. 

3. To improve certification, technical standards and regulation. 
Council Directive 93/42/EEC should be applied, along with adoption and ratification of strict 
technical standards for marketing breast implants in the EU. A harmonised standard is a technical 
specification (European standard or harmonisation document) adopted, on a mandate from the 
Commission by the competent bodies (European Committee for Standardisation -CEN, Cenelec) 
in accordance with the general guidelines on co-operation between the Commission and the 
bodies(Council Directive 83/189/EEC). Relevant European standards for breast implants include 
generic standards for risk analysis (EN 1441), non-active implant standard (EN ISO 14630), 
sterilisation, biological safety and other specific standards for breast implants (EN 12180, recently 
approved ). The different safety–related features of breast implants, including biocompatibility, 
mechanical properties, migration of the filling and shell material, compatibility between shell and 
filling material, ageing, stability and labelling have been examined within the European 
committee for standardisation (CEN) and within a special working party of certification bodies in 
charge of these products on the basis of Directive 93/42/EEC. These should be carefully examined 
and reviewed by the legitimate European officers with the potential assistance of qualified experts. 

4. To promote the elaboration of clinical guidelines, standards of care and the development 
of quality assurance systems. 
Some problems have stemmed from the lack of explicitly standardised quality standards and 
clinical guidelines. Specific training and specialised competence should be demonstrated by 
surgeons to carry out plastic reconstructive and aesthetic surgery in the EU. Harmonisation of 
standards for units and facilities allowed to offer these implant prosthesis is a goal to be achieved. 
This measure would seek to improve and harmonise quality standards and procedures throughout 
Europe. It includes fostering a regulatory framework for promoting transparent professional 
behaviour of high ethical standards, and liability when appropriate. Appropriate consideration of 

 
 
 
 
 
 
 
 
 
 
 
 
 
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Silicone breast implants 

indications and properly carried out surgical procedures are essential steps. The relevant scientific 
societies could play an active role in this area. 

5. To facilitate consensus, promotion and support of effective surveillance systems to report 
adverse effects and long-term effects.  
In the absence of breast implant registries in most countries in Europe, little descriptive data is 
currently available on women who have received implants, types of implants, procedures, 
problems, etc.  

A systematic and prospective registry of European woman with breast implants could help track 
adverse health effects and provide information on the diffusion and characteristics of this market. 
Registries are often used for multiple purposes. Thus, discussions should take place around 
development of a standard prospective registry in place by country which would then be compiled 
at the central level for Europe. 

6. To consider silicone breast implants a research priority and make funds available in the 
EU research programmes, specifically focusing on some of the shortcomings of research to 
date.  
Priority research should concentrate on: 
• long-term outcomes –illness and health, systemic health effects at sites distant from the implant 
(not just autoimmune disorders and cancer), and possible effects on the health of children of 
women with implants;  

• reliable techniques for measuring silicone concentrations in body fluids and tissues, and tissue 

responses to the presence of silicone; 

• local complications, including local effects at the site of the implant. 

Studies should have large sample sizes, control for variations in implants, and include stratified 
analyses (of reconstruction and augmentation patients). 

7. To foster tolerance and self-esteem and other conceptual alternatives to breast implants, in 
collaboration with active groups in this field.  
In light of the potential risk of any surgical procedure, it is important to foster self-esteem and self-
tolerance (proper respect to an individual’s own appearance) and sensitise European women about 
the benefits and risks of, particularly, cosmetic breast implants. At the same time, focus should be 
placed on seeking good alternatives to satisfy demands for implants. A proposal such as the one put 
forward by the European Institute of Women’s Health (see Annex A) seems particularly sensible. 

3.2. Arguments and evidence 

3.2.1. Background information, including arguments for and against the health risks of silicone implants 
3.2.1.1. General and specific health risks posed by silicone implants, their effects on the body, the 
brain and the nerves; possible influences on the genetic make up 

One of the difficulties studying breast implants and associated risks has to do with the fact that silicone 
implants have essentially experienced three different stages: a first generation (1960s to mid-1970s: thick 
silicone shell, and smooth); which presented a high rate of gel bleed and capsular contracture; a second 
generation (mid 1970s to late 1980s: thin silicone shell, and smooth), which showed a high rate of gel 
bleed and rupture; and a third generation (mid-1980s to present: thick silicone shell and textured), which 
point to lower rates of gel bleed, rupture and capsular contracture. In addition, the tremendous variety of 
implants on the market, including hundreds of different types, complicates their study. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Silicone breast implants 

Health effects related to silicone breast implants have been recently reviewed extensively. Several studies 
have been published in the last few years, mainly focused on questions posed by litigation cases. Some 
methodological shortcomings have underlined the need for new research on the safety issue. For example, 
the available studies focus on a few well-defined autoimmune diseases or cancer rather than provide a 
comprehensive evaluation of diseases, symptoms or complications. The sample sizes used are not large 
enough to precisely detect a risk increase of such rare diseases considered. In addition, the studies include 
women with implants for varying periods of time, of which some are very short. Implants for 
reconstruction in women who have had breast cancer have not been sufficiently evaluated (under-
represented in studies). Due to the intrinsic heterogeneity of the problem, it is understandable that even a 
close-to-perfect study design would only answer part of the story. Optimal studies would separately 
analyse patients with saline and silicone implants, consider different generations of silicone gel implants, 
focus on long-term implant use, differentiate between patients with implants for augmentation and 
reconstruction, evaluate any risk of serious illness as an outcome, compare with a appropriate control 
group and have a sufficient sample size.  

The available studies on the main possible health effects associated to breast implants have been analysed 
and reviewed. Overall, most published epidemiological studies found no significant health problems 
associated with silicone breast implants. 

Systemic Effects 

Cancer  
Experimental carcinogenicity and human malignant neoplasms of the breast and other cancer sites 
have been analysed and reviewed with negative findings. 

Summarising first the experimental evidence, it seems clear that subcutaneous implantation of 
silicone compounds in rodents may produce local tumours at the implantation site. To learn more 
about the practical implications of these findings, toxicology studies have examined carcinogenic, 
mutagenic and teratologic effects (Bryson G, Bischoff F.;1967). The effects of doses of many 
orders of magnitude higher than could been achieved in women with silicone breast implants have 
been analysed. Toxic effects that have been found occur at extremely high exposure levels. Thus, 
this phenomenon is not believed to occur in humans. Even though some cases of cancer occurring 
in the breasts of women injected with silicone for breast augmentation have been reported, these 
cases not constitute useful evidence of any carcinogenic effect of silicone in humans. 
Epidemiological studies have not found elevated relative risks for breast cancer in women with 
implants. In fact, analyses of large groups of women participating in cohort and case-control 
studies have shown that there is no association or even a slightly reduced incidence of breast 
cancer in women with breast implants (Berkel H, et al. 1992; Birdsell D.C:,et al 1993; Brinton L, 
et al. 1996; Bryant H, and Brasher, 1995; Deapen et al. 1997;.Friis S, et al. 1997; Kern KA, et al. 
1997; McLaughlin JK, et al 1998; Park AJ, et al. 1998).  

In addition, a 1998 report by the Independent Review Group (IRG), Committee on 
Carcinogenicity in the UK, concluded that there was no evidence of any risks of cancer within 
human hosts. The available evidence does not support an association of silicone breast implants 
with other non breast cancers (Herdman R., 2000a). 

The IOM report concluded that there is no increase in primary or recurrent breast cancer in 
implanted women. However, as women have not been followed over long periods of time, it is 
still early to completely rule out increased risks of cancer from silicone breast implants. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Silicone breast implants 

Trying to summarise the current evidence, there appear to be sufficient, consistent and convincing 
studies to support the conclusion of no association between breast cancer and implants, although 
more research is needed to rule out long-term risk of cancer. There is still limited evidence that 
silicone breast implants are not associated with non-breast cancers (other solid tumours, sarcoma, 
lymphoma, or myeloma), and the ongoing and future studies will hopefully shed light on this 
point. The available evidence does not support an association of silicone breast implants with 
other non breast cancers. 

Mammography and breast cancer 
A side problem with silicone implants is potential interference with mammography readings, 
possibly delaying breast cancer detection by "hiding" a suspicious lesion. Breast implants interfere 
with diagnostic and screening imaging examinations of the breast by compressing and distorting 
breast tissue, requiring special views, and by interposing (particularly with gel-filled implants) a 
radiopaque mass that obscures some breast tissue. Also, it may be difficult to distinguish calcium 
deposits formed in the scar tissue from a tumour when interpreting the mammogram (12 relevant 
studies summarised by IOM). Subpectoral implants do not interfere with mammography to the 
same extent as subglandular implants. The technician conducting a mammogram needs to be 
informed if a woman has implants, so special techniques can be used to obtain the best 
mammogram and to avoid rupturing the implant, which is a potential risk. It is important to 
mention that from a very recent study (Deapen et al., 2000), the evidence for no meaningful effect 
of silicone breast implants on diagnostic delay of, or greater eventual mortality from, breast cancer 
is stronger, but mammography should be performed routinely and using the Eklund views (Roger 
Herdman, personal communication, April 2000).  

There are not studies yet available on differential mortality from breast cancer attributed to 
differences in detection and diagnostic delays in women with or without breast implants. 

Neurological disease 
Some authors have also reported neurological effects and symptoms in women with breast 
implants (Ostermeyer-Shoaib B,and Patten BM.,1996). These studies are mainly case series and 
reports and their findings do not seem to be consistent with other experimental and observational 
studies.  

Summarising the available evidence, in 1997 the Practice Committee of the American Academy 
of Neurology reviewed the available scientific literature and unpublished data (Ferguson JH, 
1997), concluding that the existing studies came from the weakest category of evidence and did 
not support any association or causal relationship between silicone gel breast implant and 
neurological disorders.  

Two large and recent epidemiological studies, one from Denmark (Winther JF, et al., 1998) and 
the other from Sweden (Nyrén O, et al. 1998), based on their national hospital discharge registry 
databases, failed to show evidence of increased diseases such as multiple sclerosis, neuritis, Lou 
Gehrig’s disease, or Meniere’s disease (a disorder of the inner ear) in women with implants. There 
was no statistically significant difference in the occurrence of neurological disorders between the 
study group and the control group (age-matched women who have undergone breast reduction 
surgery). 

Furthermore, toxicological and animal studies do not support the idea of silicone gel deposits as a 
cause of neurological disease. Evidence suggests that such diseases are no more common in 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Silicone breast implants 

women with breast implants than in women without them. 

The IOM report concluded that the evidence for a general neurological disease or syndrome 
caused by, or associated with, silicone breast implants is insufficient or flawed. The IOM also 
recognised that, if an implant ruptures, migrates or compresses nerves, it can cause pain and other 
localised neurological problems.  

In conclusion, and even though neurological symptoms or diseases have been reported in some 
case series of women with breast implants, the most properly designed and conducted 
epidemiological studies show no evidence that silicone breast implants cause neurological signs, 
symptoms, or disease. Further study is needed in this area before entirely ruling out increased risk. 

Well-defined connective tissue diseases (related to autoimmune disorders) 
In addition to results on cancer, recently published studies have shown that women with silicone 
gel-filled breast implants do not have a greatly increased risk of the other major concern of 
silicone implants, some well-defined autoimmune diseases (potentially fatal connective diseases), 
such as scleroderma, lupus erythematosus, rheumatoid arthritis, Sjögren’s syndrome, 
dermatomyositis or polymyositis, and health disorders such as fibromyalgia and “chronic fatigue 
syndrome.”  

A review of 17 epidemiological studies (10 cohort, and 4 case-control and 2 cross-section studies 
reviewed by IOM) on connective tissue disease and the results of three meta-analyses (Perkins LL, 
et al. 1995; Hochberg MC and Pelmutter DL 1996; Edworthy SM, et al. 1998) were remarkable 
for their consistency in finding no elevated risk or odds for an association of implants with 
disease. One of the larger studies included, the long-term cohort Nurses' Health Study involving 
87,505 women, showed no link between implants and defined connective tissue disease or 
rheumatic conditions (Sanchez-Guerrero J, et al., 1995).  

The IOM committee concluded that there is no evidence that silicone breast implants contribute to 
an increase in autoimmune and connective- tissue diseases.  

The IRG, examining case control and cohort studies conducted between 1970 and 1998, reviews, 
and meta-analyses focusing on the incidence of established connective tissue diseases, concluded 
that there is no epidemiological evidence of any link between silicone gel breast implants and any 
established connective tissue disease. According to the IRG, if there is a risk of connective tissue 
disease, it seems to be too small to be quantified.  

The overall biological response to silicone is consistent with conventional forms of response to 
foreign materials, rather than an unusual toxic reaction. 

The US National Science Panel’s (NSP) specific main objective was to review and critique the 
scientific literature pertaining to the possibility of a causal association between silicone breast 
implants and connective tissue diseases, related signs and symptoms and immune system 
dysfunction. The report concluded that no association was evident between breast implants and 
any of the individual connective tissue diseases, all definite diseases combined or other 
autoimmune/rheumatic conditions. One meta-analysis included only studies that distinguished 
silicone gel-filled breast implants from any other type. Results were consistent with those from 
other meta-analyses where breast implants were more broadly defined. There was no association 
found between silicone gel-filled implants and any of the definite connective tissue diseases or the 
other autoimmune/rheumatic conditions. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Silicone breast implants 

A very recently published, comprehensive and consistent meta-analysis of the relation between 
silicone breast implants and the risks of connective -tissue diseases (Janowsky EC, et al, 2000) 
reviewed nine cohort studies, nine case-control studies and two cross-sectional studies. The study 
has been taken in part from the NSP report. This study incorporates eight studies not included in 
the three earlier meta-analyses. The authors adjusted for confounding factors, and conducted a 
separate analysis restricted to silicone gel-filled breast implants. There was no evidence that breast 
implants were associated with a significant increase in the summary adjusted relative risk of 
individual or combined connective-tissue diseases, or with other autoimmune or rheumatic 
conditions. No evidence was found of significantly increased risk in the unadjusted analyses or in 
the analyses restricted to silicone gel-filled implants. 

Atypical connective tissue or novel systemic disease 
A substantial number of women experiencing severe systemic illnesses are convinced that they are 
caused by their silicone breast implants. In most cases, the silicone breast implants do not appear 
to be causally related to these illnesses since they seem to occur at about the same frequency in 
women without implants.  

Some studies have signalled the existence of an undefinable, atypical disease (Patten BM and 
Ostermeyer-Shoaib B.,1995; Ericsson AD.,1998; Brawer AE.,1996), but these are mainly case 
reports with no control group and rely on very small sample sizes. Some studies have pointed to a 
lessening or disappearance of symptoms after extraction (Kaiser W, et al., 1990) and another 
study found a significantly lower duration of implants in asymptomatic compared to symptomatic 
women (Zandman-Goddard G, et al, 1999). It should also be noted that there are some clinicians 
who have treated ill women with silicone breast implants and who claim the existence of a 
silicone-specific disease, sometimes referred to as siliconosis of silicone breast implant adjuvant 
syndrome (Shanklin DR and Smalley, 1998) (for additional informationand documents provided 
by self help group, see also Annex B1 ). The issue is complicated by the fact that the proposed 
syndromes often involve ill-defined subjective symptoms (49 signs and symptoms listed by 
Tugwell P, in NSP 1998). Most importantly, and although from a scientifically orthodox 
standpoint these are these mainly anecdotal studies and reports, they underline the importance of 
further studies in this area.  

On the other hand, the IOM report concluded that there is no rigorous, convincing scientific 
support or significant evidence of a "novel" systemic disease as some researchers have claimed, 
caused by the presence of silicone implants. Evidence for an atypical disease has been considered 
insufficient or flawed (case series, few describing a reproducible syndrome),and other controlled 
studies provided stronger, contrary evidence.  

The NSP report describes the problems in analysing these studies (non-specific signs and 
symptoms, self-report not verified, timing in relation to the implant not known, small number of 
women studied, complaints reported are very common in the general population), and states that 
no distinctive features relating to silicone breast implants could be identified.  

The IRG report also points out the difficulties of identifying a specific syndrome associated with 
silicone gel breast implants with available data. There have been very few studies comparing an 
unselected group of women with implants with a matched population group to examine the 
frequency of such symptoms. IRG concluded that good evidence for the existence of atypical 
connective tissue disease or undefined conditions such as "silicone poisoning" is lacking. It is 
possible that other conditions such as low grade chronic infection may account for some of the 

 
 
 
 
 
 
 
 
 
 
 
 
 
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non-specific illnesses noted in some women with silicone gel breast implants (fatigue and 
musculoskeletal pains) and further research on this would be required.  

At the same time, however, the studies available do not rule out the possibility that a subset of 
women with implants may have a small increased risk of these conditions, or that some women 
might develop other immune-related symptoms that don't fit into "classic" disease descriptions.  

In sum, the epidemiological literature has indicated that the evidence for an atypical disease or 
novel syndrome is insufficient and that there is no robust, convincing support for these disorders. 
However, the existence of a specific syndrome or syndromes in women with silicone breast 
implants cannot be completely proven or dismissed at this point in time, and deserves further 
analysis. 

“Vertical” Effects (mother to child) 

Risks to infants  
The silicon concentration in milk in general has been a matter of concern for some specialists in 
the field. A major concern about implants has been the possible ill effects of the silicone, a 
compound of silicon (see 3.3.Technical file), on infants who are breastfed. However, much higher 
levels of silicon have been measured in cows' milk and commercially available infant formula 
than are found in the milk of nursing mothers with breast implants for augmentation. The 
exposure to silicone in many forms is very extensive (diet, environment), so the exposure of 
children born to women with an implant is no greater than that to which they are exposed from 
other sources. There is no evidence of elevated silicone levels in breast milk or any other 
substance that would be harmful to infants, nor are there any differences in the milk and blood 
silicon levels between nursing mothers with implants and those without. There is no evidence of 
disease or congenital flaws resulting from silicone or any other harmful factor in breast implants 
crossing the placenta to the unborn child.  

There is limited evidence that periareolar incision for prosthesis implantation could interfere with 
natural lactation. 

The IOM report concluded that the evidence for an association of maternal silicone breast 
implants and children’s health effects is insufficient or flawed.  

The IRG report reviewed the papers on this issue (the majority are individual non comparative 
case studies), and concluded that the published literature does not substantiate the claims that 
there are significant, clinically apparent, effects in children of women who have had implants. 

In summary, studies have concluded that there does not appear to be evidence of harmful effects 
to infants breast-fed by women with silicone breast implants (connective tissue or autoimmune 
disease .  

3.2.1.2. Life span effects of silicone implants after 4, 8 and 12 years 

Local Effects 

Local complications 
A large potential health hazard (which recent studies now point to as the main health concern of 
silicone breast implants) has to do with the local complications that are clearly related to breast 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Silicone breast implants 

implants, such as rupture and migration of the silicone gel, capsular contracture (shrinking of scar 
tissue around the implant, which can cause painful hardening of the breast or distort its 
appearance), and infection. Some of the risks posed by silicone implants are attributed to the 
leakage of silicone gel through ruptured shells of silicone implants. Local complications have 
been considered as the primary safety concerns with silicone breast implants (Herdman R., 2000 
b). Regarding rupture alone, for example, published studies show that it is experienced by 
between 5% and 51% of women with silicone breast implants, which represents a very large range 
(Reviewed by IOM).  

The relatively high frequency of local complications that are unique to women with silicone breast 
implants is quite significant. Although they are not normally life-threatening, these local 
complications may result in discomfort, inconvenience, explantation, disfigurement, pain, and 
other morbidities, and when further corrective procedures are necessary, an additional potential 
risk (e.g. additional surgery) and expense. Although breast surgery has a low risk of death, many 
complications occur when implants are removed, revised or replaced. 

The occurrence of local and perioperative complications presented in reports is extremely 
variable. Differences observed are due to individual biological variability, differences in women's 
characteristics (age, comorbidities, indication for implant), types of implants, type of study 
(design, reporting or clinical and basic research), surgery techniques and skills of surgeons. 

The ANDEM report concluded that local complications are very frequent and they constitute the 
main health concern. The frequency of fibrous capsular contracture is considered as ranging from 
41% to 56% at four years for smooth surface implants and at about 10% for textured. The 
frequency of rupture ranges from 2% to 14% at 10 years, and it increases overtime. Low bleeding 
occurs at 10 years in 17% of cases. The incidence of local complications is not known for the new 
generation of breast implants. 

The IRG report also gives special attention to local effects (capsular contracture, infection, gel 
bleed, rupture), and recognises that the precise incidence of these complications is not well known 
and scientific data are incomplete. The IRG recommends prioritising research around this issue. 

The IOM report presented three major general conclusions regarding local and perioperative 
complications: first, they are so frequent that must be considered the primary safety issue with 
silicone breast implants (includes overall reoperations, ruptures, deflations, contractures, 
infections, hematomas, and pain); second, risks accumulate over the lifetime of the implant, but 
quantitative data on this point is lacking for modern implants and are deficient historically (lack of 
data from representative samples of the population, lack of information on implant characteristics 
that affect complications and lack of precise and reliable detection of complications); third, 
information concerning the nature and relatively high frequency of local complications and 
reoperations is an essential element of adequate informed consent for women undergoing breast 
implantation. We believe that these are sensible and practical considerations. Additionally, the 
importance of explicitly standardised clinical and surgical guidelines should be emphasised. 

Need for reoperation and replacement  
It has been found that women undergoing reconstructive surgery have greater complication rates 
than those undergoing cosmetic surgery. The operation for immediate reconstruction is more 
serious, because it involves a significant surgical procedure (mastectomy or removal of the breast) 
in addition to the implant. Some studies have suggested that from 30% to 40% of these patients 
with reconstructive surgery may expect complications. That percentage may rise when an 

 
 
 
 
 
 
 
 
 
 
 
 
 
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Silicone breast implants 

expander is used to help generate tissue growth in the breast area, and complications are probably 
more frequent when the breast has previously undergone radiation therapy. The possibility of 
more frequent and serious side effects of immediate reconstruction must be weighed against the 
psychological benefits.  

Women undergoing augmentation have fewer complications. Still, the frequencies are high. A 
large prospective study by McGhan Medical Corporation of 2,855 women with modern saline 
implants showed 18% of augmented women and 36% of those with reconstruction had 
complications within a year of receiving their implants, in one of four categories: infection, severe 
contracture, deflation, and implant removal. A 1997 Mayo Clinic Study reported in the New 
England Journal of Medicine found that 24% of women who receive a breast implant will have a 
complication requiring an additional surgical procedure within 5 years of initial implantation. 

It has also been found that women with silicone implants appear to have a greater chance of 
capsular contracture than women who have saline implants (Gylbert LO, et al., 1990). 

Breast implants have a limited lifetime, which is not yet very well established. The odds of having 
at least one replacement implant are high, and some women have had many more. The IOM 
committee found that a large number of women with implants could expect to have an additional 
procedure within the first 5 years after the original implant. A study of women receiving 
reconstruction over an average of 6 years showed 16% of those with saline implants required 
replacements because of deflations and another 8% due to misplacement or severe contracture 
(Gylbert LO, et al 1990). Another study reported an l8% implant loss in women reconstructed 
with gel implants or submuscular expanders. A smaller study of women with implant 
complications showed that, on average over 12 years, there were about three implant procedures 
performed per woman. The risks of having a replacement operation continue to accumulate over 
time. This deserves further consideration in ongoing and future studies. 

Rupture 
When the rupture of a silicone gel implant occurs, the gel can sometimes escape or leak into other 
tissues, (extracapsular). Often, the gel is contained in the space between the fibrous capsule and 
the implant, and the rupture goes unnoticed (intracapsular). Surgery for extracapsular rupture 
consists of removal of the implant (explantation) as well as the capsule surrounding the implant 
(capsulectomy). These operations will require anesthesia, incisions, and stitches. The surgical 
procedure may include a new implant as well.  

The frequency of rupture is reported in most studies based on findings at explantation (standard 
for diagnosis), detection by mammographic technologies and surveys of results in cohorts of 
patients. On case series reported from surgeons, the detection of ruptures depends on patient 
complaint, routine screening mammography or physical examination, none of which is absolutely 
reliable. The lower rupture rates reported by manufacturers based on returns, complaints, legal 
proceedings and other sources probably are affected by underreporting and low sensitivity. 

Many different studies have reported extremely variable rupture rates of gel implants, ranging 
from 0,3% to 96%. There is a relationship between implant age and rupture. As an example, some 
results on rupture reported are 62,5% ruptured for 10 years (Malata CM et al., 1994), 71,2%  
ruptured at 14 years , and 95,4% ruptured at 20 years (Robinson OC, et al., 1995).  

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

In fact, the extreme variability of these percentages is due to the type and model of the implants, 
their length of implantation, the types of groups of women studied and many other factors. It is 
necessary to consider that ruptures are not always detected, that composition of implants has 
changed over the years, and that it is difficult to detect later ruptures (due to short time periods of 
follow-up). 

According with implant vintage, first generation implants (1963-1972) have very few ruptures, 
second-generation implants (1972-mid 1980s) experience a 95% rupture rate at 12 years, and 
third-generation implants (late 1980s to date) had only 3,5% ruptures by 1992 (Peters WJ, et al., 
1996). We do not currently have enough information about long-term effects of the third 
generation implants, so it is not possible to precisely predict current rupture frequencies. Available 
information suggests that rupture may be more common in current gel-filled implants than in 
current saline-filled implants and expanders (IOM), although new studies are needed to resolve 
this issue. 

Based on recent observations, some authors have estimated that probably less than 10% of modern 
gel implants will have ruptured by five years and that ruptures will continue to accumulate and 
prevalence will increase in ensuing years. The safety implications of rupture include the risks of 
additional surgery and anaesthesia (explantation or replacement). 

A fact that needs to be kept in mind is the effect of bias in estimating the rupture rates of gel-filled 
implants, based mainly on explant series (overestimation or rupture frequency), instead of 
measuring rupture in more representative women using sensitive diagnostic tools. Dismissed 
variation and inclusion of implants no longer in use in most explant series do not provide a good 
basis for an estimate of modern or future rupture frequencies. Rupture rates of modern implants 
will not be known until long-term, prospective observational studies of sufficient large and 
random cohorts of women are completed, using reliable detection methods (Magnetic Resonance 
Image, MRI). 

Deflation.  
Deflation is basically a problem of saline-filled, not silicone gel-filled, implants  
Early saline implant models had frequent deflations; later ones have shown less chance of this 
happening, with a 5% to 10% frequency after 10 years (IOM).  

The IOM committee concluded that deflation of modern first-year saline implants might range 
from 1% to 3% and that this percentage would rise steadily with time. The IOM report strongly 
recommends more studies to answer questions about today's implant rupture and deflation rates. 

Capsular Contracture 
The production of an enclosing capsule of fibrous scar tissue around the implant is an important 
component of the foreign body reaction. A severe capsular contracture can cause painful and 
disfiguring squeezing as well as distortion of both the implant and overlying tissue. The ensuing 
complications can be serious, including additional medical procedures to break down the capsule, 
or to remove it, or even to replace the implant itself. Additional surgery has its own risks, 
including infection, possible ruptures, and the hazards of anaesthesia. Some of these medical 
procedures, particularly “closed capsulotomy,” where strong pressure is applied to the outside of 
the breast to help break up the fibrous capsule, are performed repeatedly on the same women. 
Problems with capsular contracture made up 28% of secondary procedures carried out on women 
with breast augmentation and 14% of those with reconstruction.  

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

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The severity of contracture is often measured using the Baker Classification (most common 
standard), which has four categories: 
Class I. The augmented breast is as soft as an unaugmented one.  
Class II. The breast is less soft and the implant can be palpated (felt) but is not visible.  
Class III. The breast is more firm and the implant can be palpated easily and can be seen (or a 
distortion can be seen).  
Class IV. The breast is firm, hard, tender, painful, and cold. Distortion is marked.  
Most surgeons consider the first two classes satisfactory but not the last two.  

The reported prevalence of contracture depends on several factors, such as varying degrees of 
detection, placement of implants, texture and other characteristics of the implant, steroid use, 
selection bias, length of follow-up. Reports used different units (patients, breasts), Baker classes 
or other, refer contractures into class II-IV or II-IV. 

Women have shown considerable tolerance for contracture, either by not seeking medical 
attention for class III or IV contractures or by pronouncing themselves satisfied with their 
implants when surveyed. A 1990 study reported that 85% of women appeared satisfied with their 
implants even though 35% had experienced severe contracture (Gylbert LO, 1990). A 1997 report 
on 186 implants showed Class III and IV contractures continuing to occur (100% at 25 years) 
(Strom SS, et al., 1997). Treatments for contracture other than closed capsulotomy include “open 
capsulotomy,” in which an incision is made into the body to break up the capsule, and a 
“capsulectomy,” or surgical removal of the capsule itself. This operation may also involve 
removal and replacement of the implant as well as loss of breast tissue. Repeated capsulotomy, 
open or closed, has progressively less chance of success.  

Although there are only limited studies, the available evidence suggests that saline-filled implants 
have a reduced rate of contracture compared to implants filled with silicone (IOM). Fewer cases 
of severe contracture are also reported in studies of textured surface implants compared to those 
with smooth surfaces, in women for cosmetic purposes rather than reconstructive, in women 
undergoing immediate reconstruction compared with women having later reconstruction and in 
implants placed behind the chest muscles compared with submammary implants. This lower 
incidence of severe contracture with submuscular implant placement is considered very important.  

3.2.1.3. Post-operational effects and follow-up 

General surgical risks associated with any operation are possible. These include complications 
from general anaesthesia, with symptoms and signs such as pain, nausea, vomiting, fever, 
infection, hematoma, haemorrhage, thrombosis. Skin necrosis is also possible. The chance of skin 
necrosis may be increased by radiation treatments, cortisone-like drugs, or an implant too large for 
the available space. 

A very brief description of some of the most pertinent of these complications can be found below. 

Pain associated with implantation is very common and constitutes one of the significant reasons 
for implant removal and replacement (present in 15%-20% of requests). Some authors have 
reported complaints of pain in a majority of women after implant surgery, and this pain may be 
long-term. Patients also reported more pain with implants after mastectomies compared with 9 
mastectomies alone and with implants placed under the chest muscles instead of under the skin 
and breast glands. One study (Wallace MS, et al., 1996) reported substantial local pain after 
reconstruction (up to 50%) and up to 38% after augmentation. Pain was also more common after 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

submuscular (50%) than submammary implants (21%), and with saline implants (33%) than gel 
ones (22%). About 20% to 29% of patients with pain required pain control medication. The 
implant capsule, especially when the implant is under the chest muscles, may cause painful nerve 
compression requiring additional treatment. Pain with late onset usually represents contracture 
pain, but it can also be indicative of bacterial infections or rupture. 

Infection Skin flora that reside in the lactiferous ducts of the normal breast, often can be cultured 
from implants, and can cause infections. There is suggestive evidence that the presence of bacteria 
correlates with contracture. It is not proven that infection is a cause of contracture. A few 
investigators have reported finding an association between the presence of bacteria around 
implants and systemic symptoms or breast pain, although this evidence is limited. Significant 
contractures are reported considerably more frequently than clinically observable hematomas. 

Chronic infection may occur with any surgical implant, and then, the implant may have to be 
removed and replaced. Some authors support that subclinical infections may also contribute to 
such symptoms as fatigue, muscle or joint pain, weakness, intermittent fever, and diarrhoea.  

Hematoma. Hematoma or seroma is variable reported in case series and other observational 
studies. Hematoma is considered as just a minor or small contributor to contracture. It was the 
indication for reoperation in 3,5% of the women in the Mayo Clinic series (Gabriel SE, et al., 
1997) The frequency of hematoma reported within days after implantation for augmentation and 
reconstruction with both silicone gel or saline implants varies between 0,5% and 5%. In a small 
number of cases, reoperations have been necessary to correct the problem. Rarely, hematomas 
occur many years after the implant operation in association with contracture. The main safety 
implications of hematoma involve added interventions, associated infection, and potential 
association with contracture.  

3.2.1.4. Conclusions 
The two main original causes of concern (cancer and well defined autoimmune or connective-tissue 
diseases) have been the subject of considerable scientific attention and discussion over the last 10 years. 
Despite the methodological and other shortcomings of the available studies, we can generally assume that 
no relevant increased risk exists which can be attributed to these two conditions, as they appear at the 
same frequency in the population with implants as they do in the population without implants. There 
appear to be sufficient, consistent and convincing studies to support the conclusion of no association 
between breast cancer and implants, although studies are being conducted to rule out long-term risk and 
other types of cancer. There is no evidence that silicone breast implants contribute to an increase in 
autoimmune and connective- tissue diseases, although the studies available do not rule out the possibility 
that a subset of women with implants may have a small increased risk of these conditions, or that some 
women might develop other immune-related symptoms that don't fit into "classic" disease descriptions. 
Nevertheless, the epidemiological literature has indicated that the evidence for an atypical disease or novel 
syndrome is insufficient and that there is no robust, convincing support for these disorders. However, the 
existence of a specific syndrome or syndromes in women with silicone breast implants cannot be 
completely proven or dismissed at this point in time, and deserves further analysis. 

The evidence provided from epidemiological studies that silicone breast implants cause neurological 
signs, symptoms, or disease is insufficient. There does not appear to be evidence of harmful effects to 
infants breast-fed by women with silicone breast implants (connective tissue or autoimmune disease).  

The potential interference of breast implants with mammography readings by compressing and distorting 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

breast tissue requires special techniques to obtain the best mammogram and to avoid rupturing the 
implant. 

Surgical, local and perioperative complications are so frequent that we agree with previous reports 
considering them as the main safety issue with silicone breast implants and any other type of breast 
implant. Overall reoperations, ruptures, deflations, contractures, infections, hematomas, and pain are very 
common and the main cause of women's complaints. Breast implants have a limited lifetime, which is not 
very well established. In any event, the odds of having at least one replacement implant are high. We do 
not currently have enough information about long-term effects of the third generation implants, making it 
difficult to predict frequencies of 3rd generation rupture, reoperations, and contractures. Quantitative data 
on this point is lacking for modern implants and have been deficient historically. Thus, the precise 
incidence of local and perioperative complications should be considered a research priority and an 
essential element of adequate informed consent for women undergoing breast implantation. 

See Table 1 on serious health effects considered in studies in relation to silicone breast implants. 

3.2.2. Overview of relevant primary research and reviews. Period 1990-1999 
3.2.2.1. Research currently taking place in the EU 
Various research and review efforts have been carried out in Europe, such as the report published in 
France by ANDEM (1996), and the comprehensive overview carried out by the Independent Review 
Group in the UK (1998). Other observational research initiatives have also been conducted.  

Two large and recent epidemiological studies, one from Denmark , based on national hospital discharge 
registry databases, and the other from Sweden, based on three large cohorts (Friis et al., 1997; Nyren et 
al., 1998, respectively). The Danish Cancer Society study included 1135 women with breast implants for 
cosmetic purposes, 1435 for breast reconstruction and another two groups of non implanted women. The 
study failed to show evidence of increased systemic diseases such as definite connective-tissue disease, 
multiple sclerosis, neuritis, Lou Gehrig's disease, or Meniere's disease (a disorder of the inner ear) in 
women with implants. 

In Sweden, three large cohorts were studied (Nyrén et al. 1998). Women with cosmetic breast implants 
(3502), women with implants for reconstruction (3931) and women who had undergone breast reduction 
surgery (3351) were followed for ten years through cross-linkage within hospital discharge registers. The 
author concluded that no significant increase in risk of connective tissue disease nor neurological diseases 
was apparent comparing these cohorts of woman and the general population. 

Other relevant epidemiological studies have been recently conducted in EU countries, including the cohort 
studies by Park et al. in Scotland (1998) and by Giltay et al. in The Netherlands (1994). Both studies did 
not show any relevant association between breast implants and connective-tissue diseases. 

Regarding efforts to clarify issues of safety and appropriate certification of breast implants in Europe, this 
issue has been given careful attention and has led to different interchanges and discussions between the 
Commission and Member States. This process has driven different options currently adopted by Member 
States in Europe, with the exception of France, which does not share the existing Essential Requirements 
of the European Directive (see 3.1.1.4.). 

In the UK, the Medical Devices Agency (MDA) set up an Independent Expert Advisory Group and 
published a review analysis in 1992, updated in 1994. A National Breast Implant Registry was established 
in 1993. Further details are given in 3.1.1.4. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

In Spain, a working group of independent experts reviewed the existing evidence and arrived at the 
conclusion of proposing implant and explant (implant removal) registries. We have been informed that 
within the next few months, the first analyses of data arising from these registries will be available. 

A project of systematic review by an expert panel on silicone breast implants is being undertaken by the 
Council of the Netherlands Gezondheidsraad (GR), a member of the International Network of Agencies of 
Health Technology Assessment. 

We have no information about new relevant research being developed on this issue with EU funds.  

As for technological investments and efforts, new developments in breast implant technology may change 
the horizon. Cohesive silicone gel represents an innovation. A new hydrogel formulation of 
polyvinylpirrolidone (PVP) device for breast implants has been tested and used in Europe. Also, new 
saline-filled implants that are pre-filled rather than being filled at the time of surgery with sterile saltwater 
solution could eliminate valve leakage and improve sterility. In short, these innovations may provide 
increased options for women seeking breast enlargement or reconstruction, but they need further review 
and attention.  

3.2.2.2. Current research in other parts of the world 

Breast implants have been available since the 1960s. In 1976, the US FDA placed breast implants under 
class II devices whose safety and effectiveness were considered as well established, only requiring 
performance standards or surveillance studies. In 1982, due to reported problems, breast implants were 
proposed to be moved into class III, under the strictest controls, requiring studies demonstrating safety and 
effectiveness, and all implants were placed into this category in 1988. In April 1991, in response to a 
growing number of adverse reaction reports that raised safety concerns about the silicone gel-filled 
implants, the FDA published a regulation that required manufacturers to submit pre-market approval 
applications with data showing the safety and effectiveness of the implants by July 9, 1991. The data 
submitted did not prove the devices safe, as required by law, so the agency ordered the devices off the 
market in April 1992 and restricted their use to clinical trials.  

A report by a National Science Panel (NSP) (four experts on toxicology, immunology, epidemiology and 
rheumatology) was presented in 1998 to the Honorable S.C. Pointer, Judge for the Federal Breast Implant 
Multi-District Litigation. This report reviewed the scientific literature related to silicone breast implants 
and connective tissue diseases and inmunologic dysfuntion. 

In 1997, the Institute of Medicine (IOM) of the National Academy of Sciences agreed to carry out a 
comprehensive evaluation of the evidence for the association of silicone breast implants with human 
health conditions, asked by the U.S. Congress. The final report was presented in 1999. The IOM made a 
clear distinction between local complications and systemic health concerns. The IOM determined that 
there was insufficient evidence to establish that breast implants cause systemic health effects such as 
autoimmune disease. The IOM concluded that there is no definitive evidence linking breast implants to 
cancer, immunological diseases, neurological problems or other systemic diseases. However, the IOM also 
concluded that local complications are the primary safety issue with silicone breast implants. 

In the US, silicone gel-filled implants are only available through an adjunct study (focussed on collecting 
data while allowing for continued access to the device for reconstruction and revision patients) or a 
investigational device exemption (IDE) study (focussed on collecting both safety and effectiveness data to 
support premarket approval). An IDE study also may include augmentation patients.  

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

Mentor Corporation’s and McGhan Medical’s adjunct studies, were approved by FDA in 1992 and 1998, 
respectively, both limited to reconstruction patients. In June 1998, FDA approved McGhan Medical’s IDE 
study for augmentation, reconstruction and revision patients. Clinical data of all these studies are being 
collected and submitted to FDA on an annual basis. To date, no manufacturer has yet provided data to 
support the safety and effectiveness of their breast implant, so no premarket approval (PMA) or product 
development protocol (PDP) application has been approved for silicone gel-filled implants. 

FDA recently required manufacturers of saline-filled breast implants to submit safety and effectiveness 
data, and several manufacturers submitted PMA applications for their saline implants in 1999. A meeting 
was held in March 2000 to review the PMA applications and the FDA Advisory Panel recommended their 
approval, but the FDA has not yet made a decision, which is expected before end-May 2000.  

Current studies in the US and Canada 

Currently, the largest study to date is being conducted on the long-term effects of breast implants, 
involving 13,500 women who had implant surgery before 1998. Dr. Louise Brinton, Chief of the 
Environmental Epidemiology Branch at the National Cancer Institute of the National Institutes of Health, 
is Principal Investigator. The scientists will study whether breast implants are linked to risks of breast 
cancer, other cancers or connective tissue disorders. The results of the study on breast cancer will be 
available during 2000; the findings on other cancers and connective tissue disorders will be released 
during 2001. This study aims to address many of the limitations of other studies, particularly because of its 
large sample size and its focus on the long-term effects of breast implants. 

Another study is currently under way in the US to look at rupture rates. This study should be closely 
followed. 

In 1992, Canada’s Minister of Health requested all implant manufacturers to withdraw all silicone gel 
breast implants from the Canadian market and released the Baines report, indicating that existing scientific 
information was inconclusive and more data was required on safety implants. In 1996, Health Canada 
announced a plan to fund an Ontario and Quebec Breast Implant Study focused on risk of cancer, and 
would involve 40.000 women who received implants. The Conseil d’evaluation des technologies de la 
santé du Québec has now developing a research project titled: Effectiveness of alternative imagery 
techniques in the diagnosis of leakage of silicone breast implants. 

3.2.2.3. Conclusions 

A relevant effort and investment has been made in several developed countries (mainly in U.S. and 
Europe) over the last ten years considering the health effects posed by silicone gel-filled breast implants. 
Governmental agencies and independent groups have extensively reviewed or have carried out 
epidemiological studies or meta-analyses on this topic.  

Current studies are developing on long-term effects of breast implants (mainly on cancer or connective -
tissue diseases) in the US. Manufacturers are also involved in the U.S. on adjunct studies or on 
investigational device exemption (IDE) studies focussed on collecting both safety and effectiveness data 
to support premarket gel-filled implants. Clinical data of all these studies are being collected and 
submitted to FDA. Most likely, manufacturers of saline-filled breast implants will consider the initiation 
of new IDE studies.  

Despite the research carried out, lack of information and insufficient evidence have been recognised and 
some research areas are considered of priority: 
-reliable techniques for measuring silicone concentrations in body fluids and tissues, and tissue responses 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

to the presence of silicone; 
-long-term outcomes illness and health, systemic health effects at sites distant from the implant (not just 
autoimmune disorders and cancer), and possible effects on the health of children of women with implants; 
-the frequency of local complications, including local effects at the site of the implant. 

3.2.3. Primary information obtained 

The reality of silicone breast implants is enormously complex.  

From the epidemiological literature, there is inconclusive evidence of an association between silicone 
breast implants and cancer or connective diseases, the two main original causes of concern. Studies point 
to local complications as the principal risk. However, without underestimating the importance of local 
complications or of these studies, communication and materials from key actors uncover other crucial 
information which needs to be taken into account, demanding further critical research, action and due 
consideration. 

We contacted key actors to gauge their views and positions on silicone breast implants: surgeons, 
women’s groups, scientific societies, patients, manufacturers, researchers, EU countries, other countries, 
and self-help groups. At the end of this document, we have compiled charts with response rates for these 
different groups. A summary of these groups’ responses can be found below. 

3.2.3.1. Surgeons 
Please see Annex A1 and A1/2 for sample letter and individual responses. In Table 2 there is a summary 
of responses by surgeons. 

3.2.3.2. Women’s group: European Council on Women’s Health 
Please see Annex A2 for statement on silicone breast implants. 

3.2.3.3. Scientific Societies 
Please see Annex A3 and A3/2 for letter and responses. 

3.2.3.4. Patients 
Please see Annex A4 and A4/2 for sample questionnaires and individual responses. In Table 3, please find 
a summary of patient responses. 

3.2.3.5. Manufacturers 
Please see Annex A5 for letter and individual responses. In Table 4, please find a summary of 
manufacturers’ responses.  

3.2.3.6. Researchers 
Please see Annex A6 and A6/2 for letter and individual responses. 

3.2.3.7. European Union Countries 
Please see Annex A7 and A7/2 for letter and individual responses. In Table 5, please find a summary of 
government responses. 

3.2.3.8. Other Countries 
Please see Annex A8 for the United States’ official response (we have also received useful country-
specific information from scientific societies: please see Annex A3). 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

3.2.3.9. Self-help groups 

Silicone breast implants 

We have heard and received information from self-help groups from the UK/Scotland, The Netherlands, 
Germany, Belgium, Switzerland, and Iceland (these include: Silicone Support UK (SS/UK); Action 
Against Silicone Gel (AASG/UK); Silicone Information Network (SIN/UK); Stichting Steunpunt voor 
Vrouwen met (vragen over en/of problemen door) Siliconene borstprothesen (St. SVS/NL); German 
Support Group for Victims of Silicone Implants (GHG, DE); Selbsthilfegruppe Silikongeschadigter 
Frauen e.V. (SHG/BE) Silicone Support Switzerland (SS/Switzerland); Silicone Survivor Group, Iceland 
(SSG/Iceland), respectively). 

Contact with self-help groups of women has underlined the importance of the following. 

1) Information is critical. Many women complain of not having been informed of the potential risks with 
breast implants before they had their operation. In fact, we have also been informed by some expert 
surgeons that information to patients was uncommon before 1992. A significant group of women report 
that they were not told about risks of the surgical procedure itself, the potential for infection, or the limited 
lifetime of implants. At the same time, some women who underwent explantation and/or other additional 
operations as a result of complications did so without having received proper information or without 
having given their informed consent. Specifically, two critical areas in which information was claimed to 
have been lacking were as follows: 

• 

Implants are not for life and may need to be replaced or explanted—they do not last forever, 
which was originally believed and disseminated. Many women, not informed that their 
implants would need replacing, have experienced problems years after their implantation, 
long after the time at which their implants should have already been replaced. Women need to 
be aware of this fact upfront. 

•  Rupture occurs significantly. Although exact figures are unknown, studies detect rupture rates 
of between 5%-51%, an enormous range. At the same time, some studies point to a rupture 
rate of 50% after 7-10 years and up to 95% after 20 years. Inherent with rupture are many 
problems related to local and distant inflammation, infection caused from the release of gel, 
other potential unknown problems related to gel migration, not to mention the need for 
emergency reoperation. Currently, studies in the US are looking at rupture rates and it is 
important to follow this work. In addition, women need to know about the potential for 
rupture and many were not appropriately informed. 

2) A distinction needs to be made for women considering implants for augmentation or for 
reconstruction in light of local complications alone (rupture, capsular contracture, and infection) (not 
taking into account other potential risks, such as risks inherent in surgical procedures). The majority of the 
women from self-help groups had implants for cosmetic purposes and state that, if they had been given a 
realistic view of the risks (not taking into account their current health problems), they might not have 
opted for implants. In addition, due to the lack of registries in Europe, not only are overall numbers of 
women with implants unknown, but also the breakdown of augmentation versus reconstruction patients. 
However, for example, numbers from the UK point to a larger demand for implants for cosmetic purposes, 
which, again, highlights the critical need for proper information and informed consent so that an 
appropriate, informed assessment of risks and benefits can be made. 

3) A significant body of women with silicone gel-filled breast implants are claiming the same 
inexplicable serious symptoms: chronic fatigue, dizziness, memory loss, forgetfulness, insomnia, 
abdominal pain, bowel and bladder trouble, aches and pains, flu-like symptoms, redness or swelling of the 

 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

skin, itchy scalp, rashes, tingling, extreme temperature changes, cold extremities, swallowing difficulties, 
pain in back, armpit, hands and feet, eye dryness and irritation. These women, whose symptoms have 
begun at varying times and which are experienced to differing degrees, all claim to have been healthy 
before implantation and to have fallen ill afterwards, as a result of their breast implants. In some cases, 
women have reported a reduction in symptoms after the implants were removed; in other cases, there was 
no change in symptoms after the implants were removed. We have been sent information from European 
women representing themselves and others in their 6 respective countries. Their stories and health 
problems are remarkably, eerily similar. (see Annex B1 and B1/2 for original materials sent from these 
women and self-help groups). They have provided us with references from physicians and researchers 
who have coined these symptoms “siliconosis” and believe that it is an undiagnosed, not yet classified, 
man-man-made disease directly associated with the presence of silicone gel-filled implants ( Shankin DR, 
and Smalley DL.,1998). Although there is inconclusive epidemiological research pointing to this 
association, these women seem convinced of this. While the actual number of women experiencing these 
same symptoms is unknown, it should be noted that according to the information provided by the lead 
petititoner, 2000 women in the UK alone signed the petition presented to the European Parliament calling 
for a ban on silicone breast implants. In Germany alone, according to the Head of the German self-help 
group, since 1992, 6000 sick women with silicone breast implants have sought advise from the self-help 
group. The Dutch Silicone Supportgroup has answered 17,500 calls (from 5 minutes to 1 ½ hours or 
more) and has heard 4000 stories from sick women since it was formed in 1992. 

4) The self-help groups point out the shortcomings of available epidemiological studies 
Silicone breast implants were widely used for years with no regulation, study, control or monitoring of 
their use whatsoever. The exact number of women who have breast implants is impossible to know. To 
complicate the issue, a multitude of different kinds of implants exists, as well as three distinct generations 
of implants. Thus, until 1990, there were actually not very many useful studies and/or the research that 
were conducted on silicone breast implants was not very useful in assessing risk. A great deal of attention 
and focus has been placed on silicone breast implants since the early 1990s, leading to many different 
studies. However, there are some limitations to these studies, which could be summarised as follows 
(extracted and summarized from Diana Zuckerman (1998) and other sources): 

4.1. Small sample sizes. Lack of power may hamper the capacity to detect risk of an atypical 
disease.  
4.2. Studies only focused on classic disease criteria, mainly cancer and classifiable autoimmune 
diseases, not on other problems and/or symptoms and the potential for new atypical disease. 
4.3. Lack of long-term data (e.g., 8-14 years after, when problems are most likely to arise). Studies 
only really started in the early 1990s; many women in studies were included after 1 to 5 years after 
having implant--too close after implantation. 
4.4. Comparison samples not always good. Weak sampling schemes in many studies (e.g., 
convenience samples), which could lead to non-generalizable results. 
4.5. Mixing of different kinds of implants and patients from different generations often grouped 
together, which skews results (second generation believed to have greater possibility of rupture, 
but studied with other generation implants), and augmentation/reconstruction patients considered 
together, although they have differing degrees of complication. 

For the sake of objectivity, we should also point out, however, that the published studies supporting the 
idea of an underlying link associated with silicone implants have very clear intrinsic limitations, given that 
their epidemiological designs are not strong, they are mainly case reports with no control group, and they 
rely on very small sample sizes. 

5) There is a need to address these women’s claims. Public health consists not only of epidemiological 

 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

studies, but of information and input from patients. of Overall, women from self-help groups in Europe 
have informed us that they feel that they have had no “voice” in the silicone breast implant debate. 
Generally, they feel shunned from the researchers who have been studying silicone breast implants and 
believe that their position has not been adequately reflected, they feel ignored by surgeons, and do not feel 
that they have been given adequate attention by their governments as to their very real problems.  

In Annex B1 to our draft final report, we sent all original materials and information sent to us. They were 
sent with our draft so that the European Parliament could carefully and fairly consider these in the 
assessment of the draft report and of this important issue. As an Annex to this final report (Annex B1/2), 
we send all new original materials and information received since submission of our draft final for direct 
review by the European Parliament. 

As a side, we think that a short anecdote highlights the need for further attention to the issue and for 
stronger, improved measures on silicone implants in light of local complications alone and the underlying 
risk of any surgical procedure. According to information from certain newspapers (El Pais, April 2000), 
there is a television game show currently on the air in Austria which consists of the audience’s active 
participation in the awarding of free breast implants to women contestants. 

3.2.4. Analysis of potential legal precautions to be envisaged 

3.2.4.1.Alternative levels of precaution potentially recommended taking into account the current 
knowledge about health issues. 

The different perspectives and views on the right way and the right time to impose appropriate levels of 
precaution have been a matter of a lively debate not only in the European Union, but in most regions of 
the world.  

The main objective of the creation of a Single Market in the EU was to guarantee free movement of 
products, and was based on  prevention of new barriers to trade, mutual recognition and technical 
harmonisation. However, the underlying philosophy is obviously to make this compatible with an 
acceptable level of risk for the population. 

The directives based on New Approach and Global Approach on procedures to conformity assessment 
(Council decision 90/683/EEC, decision 93/465/EEC) have the following principles: The legislative 
harmonisation is limited to essential requirements that products placed on the Community market must 
meet. In particular, these requirements deal with the protection of health and safety of users (consumers) 
and sometimes cover other requirements (property, environment); The technical specifications of products 
meeting the essential requirements set out in the directives will be laid down in harmonised standards; 
Application of harmonised or other standards remains voluntary; Products manufactured in compliance 
with harmonised standards benefit from a presumption of conformity with the corresponding essential 
requirements. 

The operation of New Approach requires that the standards offer a guaranteed level of protection with 
regard to the essential requirements established by the directives, and that the national authorities carry out 
their responsibilities for the protection of safety or other interests covered by the directive. Directive 
98/34/EC defines European standards as technical specifications adopted by European organisations for 
repeated or continuous application with which compliance is not compulsory. Accordingly to the internal 
rules of these organisations, European standards must be transposed at national levels. 

Given that this is a dynamic process, the European Parliament and the legitimate bodies within the 
European Member States needs to continuously tackle the challenge of finding the right balance between 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Silicone breast implants 

freedom of rights of individuals, manufacturing and commercial enterprise on the one hand, and the need 
to maximise the lessening of risk to human and environmental health on the other. It is self-evident that 
the EU should have the right to establish the level of health protection that it deems appropriate.  

In order to face this challenge, a scientifically-based risk assessment is usually considered as the first step, 
followed by risk management and risk communication. In other words, the scientific evaluation should be 
the pivotal element to confront this process. At times, the scientific evaluation does not fully clarify (with 
reasonable degree of certainty) the risk to be determined. Scientific uncertainty is a very common 
scenario, and –as previously stated—this is a dynamic situation by which the degree of scientific 
uncertainty may gradually change over time. In the meantime, judging what is an “tolerable” level of risk 
for society is a matter of  political responsibility.  

The right answer is not always simple, and in could range from a legally binding measure to fostering a 
research project or publicly stating a recommendation, and all of the factors need to be taken into 
consideration. The procedure tailored to provide solid basis for the right answer should be transparent and 
should involve all interested parties. The team responsible for this commissioned work has tried (to the 
extent reasonably feasible) to fulfil this transparent desire of involving the interested parties in the area of 
silicone implants in order to summarise the different views, but it may be well the case that the European 
Parliament finds the need to consider other sources of information to add to this effort. Moreover, issues 
like the one analysed in this report may need to be revisited periodically (in the light of new scientific 
data).  

The Commission of the European Communities has recently (February 2000) prepared a Communication 
on the “Precautionary Principle” which is a good reference for this purpose. Accordingly to this 
document, where action is deemed necessary, measures based on the precautionary principle should be 
proportional to the selected level of protection (taking into account that in most scenarios it is impossible 
to speak of risk equal to zero), non-discriminatory in their application (which means that comparable 
situations should be treated in an equitable way), consistent with similar measures already taken, based on 
a careful examination of the potential benefits and costs of action (or lack of action), subject to review  
(whenever new evidence arises), and capable of assigning responsibility for producing and demonstrating 
the scientific data necessary for a reasonably comprehensive risk assessment (that could be articulated 
within the structured, formalised authorisation procedures). 

3.2.4.2. Implications of new legislature 

In light of the previous considerations, the different alternatives would have pros and cons that we have 
tried to summarise in the Options section.  

In short, the ‘status-quo’ is a legitimate option, given that we have a good European legislative basis in 
place, and there is no evidence of serious risks, but it would perhaps dismiss the perspective of self-help 
groups and the current areas of scientific uncertainty in the field of local complications and secondary 
effects. Moreover, the need for an improved harmonisation on clinical guidelines, quality assurance and 
informed consent is apparent. 

The option consisting of a complete ban on silicone breast implants could be based on the need to fully 
complete information regarding risks and petitions by some groups. However we also need to keep in 
mind the large demands by women for these implants, especially considering some problems with the 
main alternatives (and incomplete data on many of these alternatives). Also, studies on silicone-gel filled 
implants tend to be highly consistent in showing inconclusive evidence of risks of serious health concerns, 
and in pointing to local complications as main health concern, also present in alternative implants. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

Therefore, the non-discriminatory and the consistency principles would go against this option. Finally, 
there would also be the potential for economic damage to industry, job losses and other social dynamics 
which have an impact on health (the action’s cost/benefit principle would perhaps be an element to be 
precisely determined). 

Lastly, the option consisting of no complete ban, but the adoption and implementation of critical specific 
measures to increase and improve information for patients, tracking and surveillance, quality control and 
assurance and key research (see seven proposed measures in the options section) could be reasonably 
consistent with the philosophy underlying the criteria of the above mentioned European precautionary 
principles. 

 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

3.3. Technical File 
3.3.1. Basic terminology and concepts  

It is essential to distinguish relevant terms. In spite of their phonetic similarity, in practical terms, we may 
be speaking about quite different compounds. 

3.3.1.1. Silicon/Silica 

When we speak about Silicon, we refer to the second most abundant element in the earth's crust. In simple 
chemical terms this is a non-metallic (or semi-metallic) element having amorphous and crystalline forms. 
It is not found in its elemental form but occurs mainly as oxides and silicates.  

Silica is the dioxide form of silicone, also called silicone dioxide, most commonly encountered as sand. 
Silica is chemically resistant at ordinary temperatures but can undergo a variety of transformations at high 
temperatures (greater than 500ºC) and pressures. High purity amorphous silica is used as a reinforcing 
agent to increase the tear resistance of silicone rubbers used in medical devices and implants. 

3.3.1.2. Silicone and polydimethylsiloxane (PDMS) 

Silicone is the name given to a family of man-made polymers (not found naturally) containing alternate 
silicon and oxygen atoms. Depending on the specific polymers’ features, we may be speaking about 
different materials (fluid, resinous, rubbery, extremely stable in high temperatures, and water-repellent). 
These are used as adhesives, lubricants, and hydraulic oils and in electrical insulation, cosmetic, and other 
products. 

Polydimethylsiloxanes (PDMS) are prominent members of the silicone family of silicon-based organic 
compounds. PDMS compounds are polymers, and the length and cross-linking of the polymer chain(s) 
affect the physical properties of these substances.  

It is important to point out that implant devices have outer shells made from an elastomer, that 
is, a high molecular weight, cross-linked rubbery substance. In fact, most of breast implants have 
a silicone shell. Then there are different kinds of fillings (a sort of gel) used in these implants. 
Silicone gel is a less cross-linked spongy substance permeated with lower molecular weight 
silicone fluids.  

3.3.2. General exposure to silicones. The use of silicone in medical devices 

There is an extensive presence of, and citizens in developed countries are widely exposed to, silicones in 
foods, cosmetics, lubricants for machinery, insulators, and a wide array of consumer products. Silicone is 
used in food processing (for example, in canned goods and ready-made meals); and as putty and sealants. 
Silicone is also used in domestic and personal products, such as cleaning solvents, hand cream, hair and 
skin products, and antiperspirants.  

Furthermore, silicone is incorporated in some medicines and medical devices. For example, silicone oil is 
commonly used as a lubricant for syringes and blood donor kits, and is utilised during surgery to repair 
retinal detachment.  

A systematic list of medical products containing silicone is included below: 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

MEDICAL PRODUCTS INDUSTRY 
Medical-grade tubing and medical-grade elastomers, adhesives, defamers and fluids.  

PHARMACEUTICAL INDUSTRY 
Monograph and medical-grade fluids, emulsions, antifoams, adhesives and silicone rubber tubing. 

OTHER MEDICAL PRODUCTS 
Temporomandibular Joint ("TMJ") silicone products; Small Joint Orthopedic ("SJO") 
products; Large Joint Products ("LJO") products; Long term implantable contraceptives; 
Silicone fluids (injections); and silicone implant products (further details given below). 

3.3.3. Breast implants. Shells and fillings. 

There is no such thing as a "standard" breast implant. Implants may come in a wide range of sizes, 
generally from 80 to 800 cubic centimeters (cc) or milliliters in volume, although 1,000-cc implants or 
expanders have been used on occasion. The diameter, or largest dimension, of breast implants ranges from 
7.5 to 16.8 cm and the projection, or profile, from 1.5 to 7.5 cm.  

It should be kept in mind that these dimensions make breast implants significant foreign bodies in both 
surface area and volume, larger than most other alloplastic (foreign substance other than human tissue) 
implants, especially when placed bilaterally. Various shapes, such as round, oval, teardrop, or contoured, 
have been available.  

Implant devices have outer shells made from an elastomer, that is, a high molecular weight, cross-linked 
rubbery substance. In fact, most breast implants have a silicone shell. Polyurethane foam-covered implants 
offered an alternative regarding the outer shell, but the foam-coated type was taken off the market in 1991 
because of concerns that the coating might increase the risk of cancer (due to the release of small 
quantities of the chemical called TDA, which has been shown to cause cancer in animals).  

Independent from the above shell, it is possible to find single-lumen and double-lumen implants. Some of 
these implants may be inflatable, so their volume can be changed during implantation using expanders 
specifically designed to be incrementally inflated.  

As for the inner materials, there are different kinds of fillings (a sort of gel) used in these implants. 
Silicone gel is a less cross-linked spongy substance permeated with lower molecular weight silicone 
fluids. Other fillers are possible and include primarily saline, but also hydrogel, trilucent and other gels.  

3.3.3.1. Alternative implants accordingly to the filling material 

3.3.3.1.1. Silicone gel filled implants 

Silicone gel breast implants are made of an outer shell of silicone elastomer filled with silicone gel. There 
have been three generations of implant since 1962 when they became available.  

First generation implants were made with a thick silicone shell, smooth surfaced and they are filled with 
silicone gel (mixture of silicone solid and fluid). These implants were manufactured from the 1962 and 
were superseded during the mid-1970s. The principal problems associated with this implant were: gel 
bleed from the implant and capsular contracture. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

Second generation implants were made with a thin silicone shell, smooth surfaced and they are filled with 
silicone gel (high rate of gel bleed). With these implants the amount of capsular contracture was reduced, 
but not the gel bleed and the risk of rupture was higher. This type of implants was manufactured from the 
1970s to the late 1980s. 

Third generation implants were made with a thicker silicone shell, a textured surface and they are filled 
with silicone gel. (high rate of gel bleed). These implants presumably reduce the amount of capsular 
contracture, rupture and gel bleed. This type of implants was manufactured from the late 1980s to the 
present. 

3.3.3.1.2. Saline filled implants 

Saline used as a filler for implants was considered a long time ago (since 1965). As for the advantages of 
saline filled implants, they have been perceived as more physiological, with no swelling or shrinking, 
while the rupture is taken up by the body itself. However they also have some clear disadvantages, 
including a higher deflation rate, an increased likelihood of shell folding, a greater weight, a fluid wave 
(“slosh effect”) with sounds that can be heard by the patient, and worse appearance than silicone gel-filled 
implants (thin consistency and wrinkling that is visible through the skin and/or palpable). Within the 
month of May, the US FDA will either approve or not approve Mentor and McGhan saline implants, 
based on the analysis of results from manufacturers’ required reports and studies. The FDA Advisory 
Committee recommended their approval at a meeting held in March 2000. 

3.3.3.1.3. Other implants 

Another option has been the so-called “Trilucent filled implants” (made with purified soybean oil), hoped 
safer than other implants due to biodegradable oil and transparency to x-rays. In the US, women were 
enrolled in a clinical study to assess this implant’s safety, and currently, FDA is analysing results. In the 
UK, this implant was banned in 1999 due to some reported problems and a lack of information regarding 
its long-term effects. This product is pending further data. 

Hydrogel filled implants offer new possibilities. They seem to be more consistent than saline, have natural 
materials, and are still “perceived” to be safe. Nevertheless, it should be kept in mind that the hydrogel is 
not isotonic, it takes up water and can swell up to point of rupture, and its safety not well established. 
Long-term studies are needed, and the risk of some toxicity is not yet ruled out.  

Autogenous tissue is mainly used in breast reconstruction. Such reconstruction are often combined with 
implants. Dermis flaps or dermis-fat-fascia grafts, musculocutaneous flat from the abdomen or from other 
sites, and microsurgical free flats have been used. 

3.3.4 .Technical summary about silicone implants and their potential effects 

3.3.4.1. Potential benefits 

Relevant and definite benefits in terms of health and quality of life seem to be substantial for many 
women demanding cosmetic breast surgery. Although women’s reasons for obtaining breast implants are 
not very well studied, self-confidence and comfort, increased self-esteem and self-image, a positive sense 
of attractiveness and social relationships are the main apparent reasons for demanding cosmetic surgery. 
Breast implants appear to be an effective procedure for satisfying these demands.  

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

3.3.4.2. Potential risks 

Systemic effects 

Silicone breast implants 

Cancer 
There are sufficiently consistent and convincing studies to support the conclusion of no association 
between breast cancer and implants. On the other hand, the short average follow-up time of completed 
studies (and the still limited evidence on this field) does not allow us to conclude whether silicone breast 
implants are or are not associated with other malignant neoplasms (other solid tumours, sarcoma, 
lymphoma, or myeloma), and the ongoing and future studies will hopefully shed light on this point. 

Some concern exists about potential difficulties posed by breast implants when screening mammography 
is taken. Radiopaque mass could obscure some breast abnormality and represent a delay in breast cancer 
detection. Available data do not allow definite conclusions, but increases in cancer mortality in women 
with implants because of diagnostic delays have not been shown. Additional mammographic views and 
specific care could be used to overcome these problems. 

Neurological diseases 
Neurological symptoms or disease have been reported in some case series of women with breast implants. 
These findings are not consistent with other experimental and observational studies. The evidence 
provided from epidemiological studies that silicone breast implants cause neurological signs, symptoms, 
or disease is insufficient. 

Defined connective tissue disorders  
These disorders of the body's immune, or defense system are mainly related to the connective tissues of 
the body (connective tissues include mucous, fibrous, fat, cartilage and bone tissues which support body 
structures and bind body parts together). There have been some concerns related to diseases such as: 

(cid:1)(cid:2) autoimmune disorders such as lupus 
(cid:1)(cid:2) scleroderma 
(cid:1)(cid:2) rheumatoid arthritis 
(cid:1)(cid:2) fibromyalgia 
(cid:1)(cid:2) “chronic fatigue syndrome” 

In summary, recently published studies have indicated that women with silicone breast implants do not 
have a greatly increased risk of some well-defined autoimmune diseases and/or potentially fatal 
connective diseases. 

Other systemic disorders 
A substantial body of women have experienced a variety of symptoms not easily definable. These 
symptoms include pain and swelling of joints; tightness, redness or swelling of the skin; swollen glands or 
lymph nodes; unusual or unexplained fatigue; swelling of the hands and feet; excessive hair loss; memory 
problems; headaches; and muscle weakness or burning. However, symptoms such as these may be present 
in persons without connective tissue disease, or without breast implants. So it is unclear at this time 
whether the signs and symptoms experienced by these women are related to their implants.  

¨Vertical¨ Effects (mother to child) 

(cid:1)(cid:2) There is currently no evidence of elevated silicone levels in breast milk or any other substance that 

would be harmful to infants, nor are there any differences in the milk and blood silicon levels between 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

nursing mothers with implants and those without. There is no evidence of disease or congenital flaws 
resulting from silicone or any other harmful factor in breast implants crossing the placenta to the 
unborn child. In sum, current epidemiological studies have concluded that there does not appear to be 
evidence of harmful effects to infants breast-fed by women with silicone breast implants (connective 
tissue or related to autoimmune disorders), although more research is needed to completely rule out 
this risk. 

Local Effects 

Effect derived from surgical procedures 
•  possible complications of general anaesthesia (nausea, vomiting and fever) 
• 
•  Hematoma (collection of blood that may cause swelling, pain and bruising, perhaps requiring surgical 

Infection 

draining) 

•  Haemorrhage (abnormal bleeding) 
•  Thrombosis (abnormal clotting) 
•  Skin necrosis (skin tissue death resulting from insufficient blood flow to the skin).  

Local effect derived from the implant device 
•  Capsular contracture (hardening of the breast due to scar tissue) 
•  Leak or rupture: silicone implants may leak or rupture slowly, releasing silicone gel into surrounding 
tissue; saline implants may rupture suddenly and deflate, usually requiring immediate removal or 
replacement 

•  Temporary or permanent change or loss of sensation in the nipple or breast tissue formation of 

calcium deposits in surrounding tissue, possibly causing pain and hardening 

•  Shifting from the original placement, giving the breast an unnatural look 
• 

Interference with mammography readings, possibly delaying breast cancer detection by "hiding" a 
suspicious lesion.  

3.3.4.3. Risks & benefits: The challenging decision 

 It seems sensible to state that the existence of potential risks associated with the intervention (silicone 
implants) must be weighed against the potential benefits perceived by women, so that the best legislative 
and policy decisions can be made. 

As previously stated (see 3.2.4.1.),  the Commission of the European Communities has recently prepared a 
“Communication “ on the “Precautionary Principle” (signed in February 2000) which is a good reference 
for this purpose. Accordingly to this document, where action is deemed necessary, measures based on the 
precautionary principle should be:  

•  Proportional to the selected level of protection (keeping in mind that risk can rarely be reduced to 

zero) 

•  Non-discriminatory in their application (which means that comparable situations should be treated 
differently, and that different situations should not be treated in the same way, unless there are 
objective reasons for doing so) 

•  Consistent with similar measures already taken (measures should be of comparable scope and 

nature to equivalent, previous situations in which scientific data are available) 

•  Based on a careful examination of the potential benefits and costs of action or lack of action (this 
understood not simply as an economic exercise, but also including non-economic considerations, 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

such as the efficacy of possible options and acceptability to the public) 

•  Subject to periodic review  (whenever new evidence arises, with action plan amended when 

necessary) 

•  Capable of assigning responsibility for producing and demonstrating the scientific data necessary 
for a reasonably comprehensive risk assessment (that could be articulated within the structured, 
formalised authorisation procedures) 

 
 
 
 
 
 
 
 
Final report for STOA 

4. CITED REFERENCES 

Silicone breast implants 

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1992;326(25):1649-53. 

2. Birdsell DC, Jenkins H, Berkel H. Breast cancer diagnosis and survival in women with and without 
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3. Brawer AE. Clinical features of local breast phenomena in 300 symptomatic recipients of silicone gel-
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4. Brinton LA, Malone KE, Coates RJ. Breast enlargment and reduction: results from a breast cancer case-
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5. Bryant H, Brasher PH. Breast implants and breast cancer-reanalysis of a linkage study.  N Eng J Med  
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6. Committee on the Safety of Silicone Breast Implants of the Institute of Medicine. Safety of silicone 
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 7. Deapen DM, Bestein L, Brodi GS. Are breast-implants anticarcinogenic? A 14-year follow-up of the 
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8. Deapen D, Hamilton A, Bernstein L, Brody GS. Breast cancer stage at diagnosis and survival among 
patients with prior breast implants. Plast Reconstr Surg. 2000 Feb;105(2):535-40.  

9. Diamond, B.A., Hulka, B.S., Kerkvliet, N.I. et al. Silicone breast implants in relation to connective 
tissue diseases and immunologic dysfunction (NSP report). Independent National Science Panel, editor. 
USA. Federal District Judge Sam C. Pointer, Coordinating Judge for the Breast Implant Multi-District 
Litigation. 1998. 

10. Edworthy SM, Martin L, Barr SG, Birdsell DC, Brant RF, Fritzler MJ. A clinical study of the 
relationship between silicone breast implants and connective tissue disease.  J Rheumatol  
1998;25(2):254-60. 

11. Ericsson AD. Syndromes associated with silicone breast implants: a clinical study and review.  J Nutr 
Envionm Med  1998;8:35-51. 

12. Ferguson JH. Silicone breast implants and neurologic disorders: Report of the Practice Committee of 
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14. Gabriel SE, Woods JE, O'Fallon M, Beard CM, Kurland LT, Melton JM. Complications leading to 
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15. Giltay EJ, Bernelot MH, Riley AH, Tan RG. Silicone breast prostheses and rheumatic symptoms: a 
retrospective follow up study.  Ann Rheum Dis  1994;53(3):194-6. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

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16. Gylber LO, Asplund O, Jurell G. Capsular contracture after breast reconstruction with silicone-gel and 
saline-filled implants: a 6 year follow-up.  Plast Reconstr Surg  1990;3:373-7. 

17. Herdman R and Fahey JrT.  Silicone implant on cancer. Cancer Invest (submited). 2000a. 

18. Herdman, R.. Personal Comunication. April, 2000b. 

19. Hochberg MC, Pelmutter DL. The association of augmentation mammoplasty with connective tissue 
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UK, B.J., editor. England: Minister of Health in the UK. 1998. 

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22. Kaiser W, Biesenbach G, Zazgornik J. Human adjuvant disease:remission of silicone induced 
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23. Kern KA, Flannery JT, Kuehn PG. Carcinogenic potential of silicone breast implants: a Connecticut 
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24. Malata CM, Varma S, Scott M, Liston JC, Sharpe DT. Silicone breast implant rupture: 
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25. McLaughlin JK, Nyren O, Blot WJ, Yin L, Josefsson S, Fraumeni Jr JF, Adami HO. Cancer risk 
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26. Nguyen, J.M., Lairy, G., and Fleurette, F.A.r. Les implants mammaires remplis de gel de silicone. 
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Études. 1996. 

27. Nyrén O, McLaughlin JK, Yin L, Josefsson S, Engqvist M, Hakelius L, Blot WJ, Adami HO. Breast 
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29. Park AJ, Chetty U, Watson AC. Patient satisfaction following insertion of silicone breast implants.  Br 
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30. Park AJ, Black RJ, Sarhadi NS, Chetty U, Watson AC. Silicone gel-filled breast implants and 
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31. Patten BM, Ostenmeyer-Shoaib B. Disquisition on human adjuvant disease.  Perspect Biol Med  

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

1995;38(2):274-90. 

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32. Perkins LL, Clark BD, Klein PJ, Cook RR. A meta-analysis of breast implants and connective tissue 
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33. Peters W, Smith D, Lugowsky S. Failure properties of 352 explanted silicone-gel breast implants.  
Canadian J Plast Surg  1996;4(1):55-8. 

34. Robinson OG, Bradley EL, Wilson DS. Analyses of explanted silicone implants: A report of 300 
patients.  Ann Plast Surg  1995;34:1-7. 

35. Sanchez-Guerrero GJ, Colditz GA, Karlson EW, Hunter DJ, Speizer FE, Liang MH. Silicone breast 
implants and the risk of connective-tissue diseases and symptoms. N Engl J Med  1995;332(25):1666-70. 

36. Shanklin DR, Smalley DL. The immunopathology of siliconosis. History, clinical presentation, and 
relation to silicosis and the chemistry of silicon and silicone.  Inmunol Res  1998;18(3):125-73. 

37. Strom SS, Baldwin BJ, Sigurdson AJ, Schusterman MA. Cosmetic saline breast implants: A survey of 
satisfaction, breast-feeding experience, cancer screening and health.  Plast Reconstr Surg  
1997;100(6):1553-7. 

38. Wallace MS, Wallace AM, Lee J, Dobke MK. Pain after breast surgery: a survey of 282 women.  Pain 
 1996;66:195-205. 

39. Winther JF, Bach FW, Friis S, Blot WJ, Mellemkjaer L, Kjoller K, Hogsted C, McLaughlin JK, Olsen 
JH. Neurologic disease among women with breast implants.  Neurology  1998;50(4):951-5. 

40. Zandman-Goddard G, Blank M, Ehrenfeld M, Gilburd B, Peter J, Shoenfeld Y. A comparison of 
autoantibody production in asymptomatic and symptomatic women with silicone breast implants.  J 
Rheumatol  1999;26(1):73-7. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

As of 11 May 2000 

Silicone breast implants 

OVERALL RESPONSE RATES 

Surgeons 9/11 (% response: 82%) 

Sent questionnaire 21/12/99 
Resent 8/3/00 
Kroll 
Clough 
Audretsch 
Delay 
Barreau-Pouhaer 
Nava 

Deraemaeker 
Demey 
Goes 
Wickmann 
Hinderer 

Responded 

Didn´t respond 

X 
X 
X 
X 
X 
X (still missing some 
information: have 
followed up) 

X 

X 
X 

X 

X 

Scientific Societies (Group e-mail message sent out to the below group) 

Sent questionnaire  
Swizerland 
Portugal 
Norway 
New Zealand 
Luxembourg 
Japan 
Italy 
Ireland 
Greece 
Germany 
Finland 
Denmark 
Belgium 
Austria 
IPRAS confederation 
Sofcpre 
Canadian Society 
SECPRE 

Responded 
X 

Didn´t respond 

X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 

X 

X 

X 

X 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

EURAPS 
NVPC 
Australian Society 
ISAPS (European Association of 
aesthetic surgery) 
INFO 
British 
American Society of Plastic 
Surgeons/American Society for 
Aesthetic Plastic Surgery 
American College of 
Rheumatology 
National Multiple Sclerosis 
Society 
Mexico 

Silicone breast implants 

X 

X 

X 
From the internet 

From the internet 

From the internet 

X 

Manufacturers 6/9 ( % response: 66,7%) 

X 

X 

X 

Didn´t respond 

Responded 

X  
X  
X 
X 

Sent questionnaire 18/1/00, later 
to Dow Corning/Eucomed 
McGhan 
Mentor    
Arion 
Dow Corning 
EUCOMED* 
Polytech 
PIP 
Sebbin 
Nagor 
* Sent information, but did not reply to structured questionnaire. 

X 

X 

X 
X 

X 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

Researchers: 4/4 (100%) 
Individual responses sent to STOA 

Sent questionnaire 
Herdsman 
Brinton 
Eisenmann-Klein 
Kees Groeneveld  

Responded 
X 
X 
X 
X 

Governments 12/15 ( % response: 80%) 

Didn´t respond 

Sent questionnaire 2/2/00 
Resent 8/3/00 
US 11/1/00 
Germany 
Austria 
Belgium 
Denmark 
Finland 
France 
Greece 
The Netherlands 
Ireland 
Italy 
Luxembourg 
Portugal 
Sweden 
United Kingdom 
Spain 

Responded 

Didn´t respond 

X 

X 
X 

X 
X 

X 
X 

X  
X 
X 

X 
X 
X 
X 

X 

X 

Self-help groups: Wrote contact petitioner Cosima Meyer 4/2/00 

Responses and materials (all originals sent to STOA), organised by Self-help groups (SHG) 
and initials of sender 

Silicone Support UK (CW) (Scotland/UK, 3 packets) 
Action Against Silicone Gel (RU) (UK) (6 packets) 
Silicone Information Network (CK), (UK, 2 packets) 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

Stichting Steunpunt voor Vrouwen met Siliconene borstprothesen (MB) (The Netherlands, 10 
packets) 
German Support Group for Victims of Silicone Implants (KH) (Germany, 2 packets) 
Selbsthilfegruppe Silikongeschadigter Frauen e. V, Belgium (1 packet) 
Silicone Support Switzerland (CM) (Switzerland, 3 packets) 
Silicone Survivor Group, Iceland (SS) (Iceland, 1 packet) 
MD´S (personal account) 
SAG (USA, packet with information from Diana Zuckerman) 
IW (personal account) 
LM (personal account) 
JWE (personal account) 
HB (personal account) 
SH (personal account) 
EH (personal account) 

 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

TABLES  
1-5 

(ORIGINAL MATERIAL FROM WHICH SUMMARY TABLES 2-5 WERE 
DEVELOPED  
CAN BE FOUND IN ANNEXES A-C OF THIS REPORT)  

 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

TABLE 1: Serious health effects considered in studies in relation to silicone breast implants 

Health effects 

IRG (1998) 

NSP (1998) 

ANDEM (1996) 

Breast cancer 

Other tumours 

Sufficient evidence  
No association 

Limited evidence  
No association 

Mammography and 
breast cancer detection 

Interference  
No studies available on 
mortality differences 

Defined connective 
tissue diseases 

Sufficient evidence  
No relevant risk increase  

Sufficient evidence  
No association  

Inconsistency between 
studies 
Small risk increase, if exists 

Atypical or novel 
systemic disease 

Lack of good evidence 
Novel syndrome difficult 
to identify 

Novel syndrome can not 
be identified 

Difficult to define 

Neurological diseases  

Insufficient evidence 

Risk to infants  

Insufficient evidence 

Local complications 

Sufficient evidence 
Lack of precise 
incidence.  
Great variability 

IRG: Independent Research Group. NSP: National Science Panel. 
IOM: Institute of Medicine. ANDEM: Agence National pour le 
Développement de l´Évaluation Médicale. 

Sufficient evidence 
Very important issue  
Not well quantified 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

TABLE 2: Summary of surgeons’ responses 

PLEASE NOTE: The surgeons who we contacted are considered to be top reconstructive surgeons and were provided to us by the Director of the Division of Epidemiology 
and Biostatistics at the European Institute of Oncology in Milan. 

Questions 

Surgeon 1 (Delay: France) 

Surgeon 2 (Demey: Belgium)  Surgeon  3 

(Wickman: 

Surgeon 4 (Kroll: US) 

1-Purpose  silicone 
implants 

-Patients informed 

-After mastectomy 

-no, not much info, before 
crisis (1992) 

-50/year aesthetic, 10/year 
reconstructive 

-patients informed 

Sweden) 

-Every week, breast  
reconstruction and breast 
augmentation (50-70/year) 

-informed, also may have to 
exchange 

-Only saline-filled (US) for 
mastectomy, 2-3 times year 

-Risks of leakage, capsular contract 
breast asymmetry 

2  Major  health 
risks 

Siliconomas, but rare with 
good follow-up 

None (minor risk: capsular 
contracture in 5.6%  of 
submuscular textured implants) 

Main problem (not major 
health risk): capsular 
contracture 

Capsular contracture (local effect 
only), leading to hard or 
asymmetrical breast 

3 Major benefits 

Reconstruction w/o 
autologous tissues & 
augmentation 

Long-standing excellent results 

Excellent “feel” 

4  View  of  what 
EP´s  position  on 
issue should be 

Authorised use in Europe and 
France 

Accept use 

5  Alternatives  to 
silicone 

Saline (but own problems, 
such as deflating) 

Inflatable saline (folds, deflates) 

Soyabean (deflates, transform of 
oil) 

Hydrogel  (change of volume) 

A more important health 
risk: patient anxiety; use of 
mammogram for detecting 
cancer 

Moves and feels like 
ordinary breast, leakage 
rare 

Every country, national 
register, fed into European 
register, include 
complications 

Saline, but harder, not as 
natural—saline expanders 
have problem of rupture 
and leakage 

Ability to reconstruct/augment a 
breast with  no donor site morbidity 

Only available if risks (highlighted 
above) are clearly disclosed 

Saline (less capsular contracture) 
and preferred 

Autologous tissue are best choice for 
reconstruction for most patients 

 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

6 Other info 

--- 

Clinical trial—30% inflatable 
saline deflated (of 120) 

Autologous tissue 

After 15 years as plastic 
surgeon, only 2 patients 
with problems 
(autoimmune diseases) 

Quality best for reconstruction with 
autologous tissue, provided that 
done correctly 

 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

TABLE 2 (continued): Summary of surgeons’ responses 

Questions  Surgeon 

5 

(Audretsch: 

Surgeon 6 (Clough: France)  Surgeon  7 

(Hinderer: 

Surgeon 8 (Nava: Italy) 

Germany) 

Spain) 

1-Purpose 
silicone 
implants 

-Patients 
informed 

-Regularly using implants, 
experience with silicone and 
saline since 1972, focus on 
implant exchange, deformity 
reconstruction and small breast 
augmentation; decrease from 
>100 devices/yr. 80s to <50/yr 
90s 

-Breast reconstruction and 
augmentation, about 300 
cases 

-Patients informed about 
rupture risk, capsule 
formation, necessity of 
lifetime follow-up 

2 Major health 
risks 

Capsular fibrosis, frequent 
repair surgery 

3 Major 
benefits 

Only benefits in cosmetic 
surgery 

-Rupture 

-Capsule formation 

-Suppleness 

-Natural aspect 

-Anatomic implants 

Authorisation to market silicone 
implants throughout Europe 

4 View of what 
EP´s position 
on issue should 
be 

Allow all implants from main 
manufacturers, as there is no 
difference regarding health 
influences; support and audit 
main registries (running one of 
largest in Europe for 10 years); 
enforce registration of all 
implant applications 

-Silicone: approximately 
800/in 30yr 

-Aesthetic (200 implants/year) and 
reconstructive surgery  (550/year) 

-informed about capsular 
contracture, surgical risks, 
given EQUAM consensus

-Patients receive information form 
from company (McGhan) and brochure 
about silicone 

Capsular contracture (only 
1 of 20 at 10 years) 

-Capsule (periprosthesis fibrosis 
reaction) 

Psychosocial benefits, 
self-esteem 

Silicone gel-filled long 
experience and 
accumulated data on 
safety 

-Patients with mastectomy: possibility 
of having normal social life with 
minimal surgery and without adding 
scars or using muscles; for aesthetic 
reasons, possibility of offering many 
options of shapes 

Harmonised EU standards 

INCOMPLETE 

Need of European 
consensus 

 
 
 
 
 
 
 
 
 
Final report for STOA 

5 Alternatives 
to silicone 

Breast conserving surgery with 
simple local tissue 
reconstruction and with coupled 
partial mastectomy 
reconstruction; autogenous 
reconstruction after total 
mastectomy or skin sparing 
mastectomy 

-Saline implants. Unique 
possibility in France since 
ban of silicone 

-Non-gel, non-saline filled 
implants (no experience 
here) 

Autologous tissue (but 
large complications), 
other materials (but with 
less experience) 

Silicone breast implants 

INCOMPLETE 

6 Other info 

Forwarded questionnaire to 
implant registry 

--- 

Silicone gel: better 
aesthetic results and safety

INCOMPLETE 

 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

TABLE 2 (continued): Summary of surgeons’ responses 

Questions 

Surgeon 9 (Barreau-Pouhaer, France) 

1-Purpose silicone implants 

With special permission from the French Health Ministry; 
about 20/year gel-filled implants 

-Patients informed 

--- 

2 Major health risks 

Rupture, capsular contracture, leakage 

3 Major benefits 

Consistency of the breast 

4 View of what EP´s 
position on issue should be 

5 Alternatives to silicone 

Silicone breast implants should be permitted. 

Autologous breast reconstruction 

6 Other info 

--- 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

TABLE 3: Summary of patients’ responses (n= 30) 

CURRENT AGE  (mean ± std. deviation) 

CURRENT MARITAL STATUS (percent) 

LEVEL OF EDUCATION (percent) 

TYPE OF SURGERY(percent) 

REASON FOR THIS SURGERY (percent) 

LEVEL OF SATISFACTION WITH BREAST 
IMPLANTS (percent) 

PROBLEMS AFTER BREAST IMPLANTS 

31,2 yrs. ± 7,8 yr. 

Single 

Married 

More than eighth grade, but not 
high school 

High school/Technical training 

University 

Breast reconstruction 

Aesthetic reason 

Small breasts 

Asymmetric breasts 

Sagging breast, post-childbirth 

Very satisfied 

Somewhat satisfied 

Indifferent (neither satisfied or  
dissatisfied) 

Somewhat dissatisfied 

No 

Yes (*) 

66,7% 

33,3% 

13,3% 

46,7% 

40,0% 

13,3% 

86,7% 

76,7% 

6,7% 

16,7% 

73,4% 

20,0% 

3,3 

3,3 

90,0% 

10,0% 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

(*) 3 cases reported problems, approximately 1 year after surgical intervention (1 capsular contracture Grade I; 1 reintervention for giving bigger 
size of implants; and 1 reintervention for corrective position of implant) 

TABLE 4: Summary of manufacturers’ responses 

Questions 

MENTOR 

MCGHAN 

ARION 

1 Position on silicone breast 
implants in light of current 
debate on safety 

Safe and effective (product data 
sheet)—extensive database to 
demonstrate safety 

Always inherent risks with any 
implant, as well as implant 
procedures 

Independent reviews comprehensive 
(NSP, IOM, IRG studies), McGhan 
includes reference to such studies in 
product information. 

Long term local complications, breast 
granulomas from leakage of silicone gel, 
frequent re-operations and partial 
mastectomy. 

McGhan´s position is that silicone 
breast implants as medical device 
have a proven safety record. 

Arion stopped manufacturing silicone gel-
filled implants and looked for alternatives 
(saline serum and hydrogel cellulosique)    

2  Any document on stand 

-Adjunct study for gel-filled 
mammary prostheses 

-2 documents for surgeons for 
informing and counselling patients 

-IOM report, Summary report Natl. 
Science Panel (NSP), IRG report, 
European Committee on Quality 
Assurance and Medical Devices in 
Plastic Surgery report. 

-Document which sets out reasons 
why McGhan believes ban is 
unnecessary and undesirable and 
would deprive patients of real and 
especially sensitive need. 

Adjunct original studies describing  35 
years of experience, data on complications 
found (breast granulomas, and test for new 
materials to fill implants (carboxy methil 
cellulose hydrogels) 

3 View of European 
Parliament´s position on issue 

Any medical device which complies 
with Medical Device Directive 
(93/42/EEC) and bears CE marking 
should be available for sale  

Should not be banned because of 
their clinical need and because they 
are safe. 

Complete ban of production and 
distribution of silicone gel-filled breast 
implants in the EU.  

Use of alternative products (saline, 
hydrogel).  

4 Information on use or sale of 
implants in EU in last 5 years 

Total European market last 5 years, 

-1999 (100,000 implants/80,000 
silicone) 

McGhan has 50% of total European 
market: (growing from 96-99) 

-1999: total sales of 48,777 implants, 

Arion has 40% of the French market and 5-
10% of European market. (approx. 22,000 
breast implants). 

 80% silicone/20% saline 

41,161 silicone; 7,616 saline 

 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

5 Other information  

70%augment./30% reconstruction 

Option for women to restore breasts 
or have better appearance, 
improving self-image 

--- 

There is excessive pressure from US 
manufactures in the EU market. The EU 
must make their own decisions. Breast 
granulomas are the main reason for 
litigation and why USA has decided  to ban. 

 
 
 
 
 
 
 
 
 
 
 
Questions 

1 Position on 
silicone breast 
implants in 
light of current 
debate on 
safety 

2  Any 
document on 
stand 

3 View of 
European 
Parliament´s 
position on 
issue 

4 Information 
on use or sale 
of implants in 
EU in last 5 
years 

Final report for STOA 

Silicone breast implants 

TABLE 4 (continued): Summary of manufacturers’ responses 

NAGOR 

POLYTECH SILIMED 

DOW CORNING 

-Confident to say silicone breast implants are safe. Controversy was from 
lack of knowledge and understanding, which has now been addressed by 
independent studies, whose findings are consistent with Nagor´s belief 
that silicone implants are safe. 

-Some risk inherent with any implant and risks associated with silicone 
implants are no greater than for other implants. 

-Considers  silicone  implants  at 
strongest  point,  due  to  studies 
which do not point to association 
between  silicone  and  cancer  or 
immune/neurological diseases 

-Considers silicone breast 
implants safe: findings 
commensurate with 
conclusions of other 
scientific reviews (IRG, 
IOM, NSP) 

-IRG and IOM Reports, NSP Report 

report 

conclusive 

-IRG 
and 
summarised  evidence,  as  well  as 
IOM report; 

-Local  complications  important, 
but  also  present  with  other 
implants 

Focus of regulation: 1) improved informed consent, with info on risks & 
benefits/sufficient time to reconsider procedure. 2) The speeding up of 
updating/making  improvements  to  existing  European  breast  implant 
standard pr EN 12180 3) European Breast Implant Registry, collating 
information  from  National  Registries  4)  Monitoring/regulation  of 
surgeons/standardised methods of patient follow-up 

-All  European  countries  should 
accept ruling on CE mark given by 
notified body; do not believe that 
product with CE mark should not 
be  allowed  to  be  distributed  in 
certain countries. 

-Have sold implants for 20 years in Europe (not ever including France): 
Majority of sales are gel-filled implants; past five years estimate 500,000 
units (100,000/year) 

-Mammary 
between 12,000-17,000/year 

implants  sales  are 

-Implant Information 
Booklet, containing 
extensive overview of safety 
of silicone breast implants 

--- 

-Has 
not  manufactured 
silicone breast implants since 
92,  out  of  medical  device 
since  mid-93, 
business 
committed to helping answer 
questions about silicone 

--- 

5 Other 
information  

-Assessment  of  individual´s  suitability  and  surgical  technique  of 
paramount importance (not just manufacturer controls) 

-France has had lax manufacturing controls, which led to many problems 
with quality control; French are now penalising industry when they were

-One of first companies to receive 
CE mark, many controls practiced 
long  before  required,  product 
in 
for 
information 

surgeons 

 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

with quality control; French are now penalising industry when they were 
main defaulters 

national 
seriously 

language 

taken  very 

 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

TABLE 5: Summary of governments’ responses 

Governmen 1 Have a specific 

legislation on silicone 
breast implants 
and/or other implants

2 Breast implants 
regulated? 
Is EU Directive 
93/42/CEE transposed? 

3 Have a breast  
implant registry 

4 View of what 
EP´s position on 
issue should be 

5 Other info 

Belgium 

No 

Yes, by Royal Decree of 
the 18/03/1999 
transposing the Directive 

No 

Sweden 

No 

No 

CE-marked silicone breast 
implants, since 1 January 
1995, are regulated in 
accordance with EU 
directive 93/42. 

No 

The legal basis exist 
(MDD 93/42). Need 
of a scientific 
opinion approved by 
expert of all 
countries and is 
necessary guidelines 
including criteria to 
verify during the 
procedure of 
conformity 
assessment 

We refrain from 
taking a position. 

__ 

*The original, completed answers to the questionnaires from countries can be found in Annex 7. 

 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

TABLE 5 (continued): Summary of governments’ responses 

2 Breast implants 
regulated? 
Is EU Directive 
93/42/CEE transposed? 

Yes, transposing the EU 
Directive 

Governmen 1 Have a specific 

legislation on silicone 
breast implants 
and/or other implants

Portugal  Medical devices and 
accesories are 
regulated by the Decree 
Law no. 273/95 (Oct 
23) and the 
Governmental Decree 
no. 136/96 (May 3) 

UK 

Not for silicone breast 
implants 

Yes, by the Medical 
Device Regulations (1994 
SI 3017) which 
implements the EU 
Directive (93/42/EC) 

3 Have a breast  
implant registry 

4 View of what 
EP´s position on 
issue should be 

5 Other info 

At the present time, the 
registration of persons 
responsible for placing 
devices on the market is 
not mandatory, except 
the person(s) responsible 
for marketing medical 
devices falling within 
class 1 or custom made 

Yes. National Breast 
Implant Registry since 
1993. 

--- 

--- 

See annex enclosed 

The Medical Device 
Agency believes 
that conformity with 
the Essential 
Requirements for 
safety and 
performance in the 
Medical Device 
Directive provides a 
sufficient 
framework for 

 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

Spain 

Protocol about use of 
breast prothesis 
(Dirección Gral. de 
Farmacia y productos 
sanitarios; Nov 9, 1992) 

Yes, Royal Decree 414/96 
(March 1) transposing the 
Directive 93/42/EEC 

No 

control 

--- 

The legal basis 
exists, but a 
European registry 
for implants and 
more information 
for consumers are 
necessary 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

Governments 1 Have a specific 

legislation on 
silicone breast 
implants and/or 
other implants 

TABLE 5 (continued): Summary of governments’ responses 
2 Breast implants 
regulated? 
Is EU Directive 
93/42/CEE transposed? 

3 Have a breast  
implant registry 

4 View of what 
EP´s position on 
issue should be 

5 Other info 

Denmark  No 

Yes, transposing the 
Directive 93/42/EEC  

No, but they have 
register for orthopaedic 
implants and 
pacemakers 

Greece 

Yes 

No, except animal 
and human tissue 
which are regulated 
by the 
Transplantation 
Committee at the 
Health Ministry 

Not yet. They are 
planning to proceed for 
to register high risk 
implants, used by the 
Hospitals  

It is important to 
regulate these 
products in order to 
prevent risky 
products being 
introduced in the 
absence of 
surveillance, based 
on legislation 

They believe  that 
the EP should issue 
an Alert Report 
stating the risk and 
requiring physicians 
to inform patients 
… 

The standard for product 
safety should be very 
strict, particularly for 
“new products.” The 
documentation of product 
safety should be 
substantial and elaborated 
according to 
acknowledged scientific 
standards 

They suggest that in 
addition to silicone breast 
implants attention should 
be paid also to other 
implants made from 
silicone 

 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

The Netherlands  No 

Yes 

Not yet 

Implant registry, 
information 
exchange 

Silicone breast implants 

See annex: Health 
Council of the 
Netherlands: Committee 
on Silicone Implants. 
Health Risk of Silicone 
Breast Implants. The 
Hague: Health Council of 
the Netherlands, 1999, 
publication no. 1999/16  

 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

TABLE 5 (continued): Summary of governments’ responses 

Governments 1 Have a specific 

legislation on 
silicone breast 
implants and/or 
other implants 

Germany  No 

2 Breast implants 
regulated? 
Is EU Directive 
93/42/CEE transposed? 

Yes (EU Directive 
93/42/EEC transposed 
into national legislation); 
also, use ¨Ordinance on 
the Installation, Operation 
and Use of Medical 
Devices;¨ ¨Guidelines for 
conformity assessment of 
breast implants according 
to Directive 93/42/EEC 
are expected to be taken 
into account. 

3 Have a breast  
implant registry 

4 View of what 
EP´s position on 
issue should be 

5 Other info 

No, but there is one 
established by one of the 
medical societies (Study 
group for reconstructive 
surgical procedures in 
gynaecology), which 
operates on a voluntary 
basis (does not include 
all implants in 
Germany). 

General ban not 
necessary. Certain 
indications and 
patients´ right to 
self-determination 
justify use despite 
residual risks. Risks 
may be directly 
associated with 
implant or surgical 
procedure; they can 
also be influenced 
by patient-specific 
parameters. 

Strict indications 
important for certain risk 
groups. Preoperative 
comprehensive 
information about 
associated problems/risks, 
and postoperative care are 
necessary (breast implants 
patient information and 
consent form). Patients 
should have opportunities 
for intensive talks with 
physician, access to 
written patient info, and a 
period of days of thought 
for making an informed 
decision. 

-- 

Luxembourg  No 

93/42/EEC directive has 
been transposed according 
to regulations 

Our country does not 
have an implant registry 

-- 

 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

Governments 1 Have a specific 

legislation on 
silicone breast 
implants and/or 
other implants 

2 Breast implants 
regulated? 
Is EU Directive 
93/42/CEE transposed? 

Finland  No (yes for some other imNot regulated, but EU 
directive 93/42/CEE is 
transposed 

3 Have a breast  
implant registry 

4 View of what 
EP´s position on 
issue should be 

5 Other info 

Without knowledge of 
long-term effects, breast 
implant registries should 
be established to find out 
1) possible diseases and 
long-term effects in 
women and offspring; 2) 
real rupture rate of breast 
implants; 3) rate of 
encapsulation 

No, but there is a Law 
on Medical Devices 
(1505/94 and act 
1506/94) which requires 
every health care 
professional who 
implants this kind of 
device to have a registry 
in his/her clinic to 
identify implant 
recipients in case of 
problems. 

There is a current study 
on cohort of breast 
implant recipients, from 
1960s-1998. 

EU should take 
active role in 
regulating silicone 
breast implants in 
Europe. Long-term 
effects unknown (on 
women and 
offspring). Rupture 
increases with 
length of implant, 
and can happen 
silently (without 
knowledge by 
women), and local 
complications are 
problems. Good 
choice for 
reconstruction, too 
risky for 
augmentation. 
Difficult to obtain 
information about 

 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

implants before 
operation (Hovi 
1999)1. Problems 
with soya bean oil 
filled implants 
example of possible 
consequences 
without experience 
(rupture, chemical 
reactions, etc.). 

TABLE 5 (continued): Summary of governments’ responses 

1 Hovi Sirpa-Liisa, Hemminki Elina, Swan Shanna H., Cosmetis and postmastectomy breast implants: Finnish women’s experiences. Journal of women’s 
health and gender-based medicine, 8(7) 1999, 933-939. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Final report for STOA 

Silicone breast implants 

Governments 1 Have a specific 

legislation on 
silicone breast 
implants and/or 
other implants 

2 Breast implants 
regulated? 
Is EU Directive 
93/42/CEE transposed? 

3 Have a breast  
implant registry 

4 View of what 
EP´s position on 
issue should be 

5 Other info 

France 

Yes (since May 1995, Yes (16/03/1995) But CE-

No 

marked prostheses only 
approved in France if a 
specific evaluation is 
demonstrated in each 
case. This is felt to be 
missing. Only salinfilled 
prostheses currently fulfil 
this requirement. 
MEDDEV document 
(from an ad hoc working 
group) makes operational 
recommendations for 
specific evaluation of 
breast prostheses. 

-- 

It seems necessary 
to ensure the 
existence of a 
reference procedure 
for evaluating breast 
prostheses, in order 
to ensure the 
essential health and 
safety requirements. 

The MEEDV 
document could be 
used as the ground 
basis for discussion.

 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

STOA PROGRAMME 
European Parliament 
Directorate-General for Research 
Directorate A 

Room SCH 04 A034 
Schuman Building 
Kirchberg 
L-2929 Luxembourg, 
Tel (352) 4300.22511;    
Fax (352) 4300.22418 or 24167  

RoomASP 6D46 
Altiero Spinelli Building 
60, rue Wiertz 
B-1047 Brussels, 
Tel (32-2) 284.3812 
Fax (32-2) 284.49.80 or  9059 

or 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Final report for STOA 

Silicone breast implants 

E-mail: gchambers@europarl.eu.int 

E-mail:tkarapiperis@europarl.eu.int