Communication from the Commission on community and national measures in relation to breast implants (Text with EEA relevance)
Date: 2001-11-15
Institutions: European Commission
Subjects: European standard, access to information, disease prevention, health policy, medical device, patient's rights, product safety, surgery, woman

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 15.11.2001
COM(2001) 666 final

COMMUNICATION FROM THE COMMISSION

ON COMMUNITY AND NATIONAL MEASURES IN RELATION
TO BREAST IMPLANTS

COMMUNICATION FROM THE COMMISSION

ON COMMUNITY AND NATIONAL MEASURES IN RELATION
TO BREAST IMPLANTS

(Text with EEA relevance)

Table of contents

1.

2.

3.

4.

5

Background .............................................................................................................. 3

Directive 93/42/EEC and its application to breast implants ....................................... 3

Content of Informed Patient Consent ........................................................................ 4

Research and Development; Innovation .................................................................... 5

Monitoring of policy measures.................................................................................. 6

Annex 1 - ESSENTIAL SAFETY REQUIREMENTS AND CONFORMITY

ASSESSMENT SCHEMES OF DIRECTIVE 93/42/EEC ON MEDICAL
DEVICES IN RELATION TO BREAST IMPLANTS.............................................. 7

I.

II.

III.

IV.

V.

Introduction .............................................................................................................. 7

General Requirements............................................................................................... 7

Pre-market assessment .............................................................................................. 8

Post-market surveillance by the manufacturer ......................................................... 11

Information – Labelling .......................................................................................... 11

Annex 2 - INFORMATION TO BE PROVIDED TO WOMEN WHO ARE

CONSIDERING RECEIVING BREAST IMPLANTS ........................................... 13

I.

II.

III.

IV.

V.

VI.

Information on implants.......................................................................................... 13

Information on surgery ........................................................................................... 14

Effects .................................................................................................................... 14

Contraindications.................................................................................................... 15

Monitoring/who to contact...................................................................................... 15

General information................................................................................................ 15

2

1.

BACKGROUND

Although overall figures are not available, it is estimated that in Europe an increasing
number of women receive breast implants. Breast implants can be used either for re-
constructive surgery, or for cosmetic reasons in plastic surgery. Breast implants are
placed in the breast as part of a surgical operation.

implants, saline filled breast

There are various types of breast implants, based on the filling material: silicone gel
breast
implants, hydrogel or soybean oil filled breast
implants. They present different characteristics, such as consistency-viscosity and
“feeling”, expected life-time, or molecular migration.

In 1998, petitions were introduced to the European Parliament, by a group of women
having received silicone gel breast implants. In the light of these petitions, the European
Parliament ordered a study on “Health risks posed by silicone implants in general with
special attention to breast implants”, carried out by a team of scientific advisers led by
Prof. Moreno. The report presented 1 confirmed the absence of scientific evidence on a
link between disease and silicone gel breast implants. It noted, however, that problems do
occur, mainly because of the design and characteristics of the product. These relate
mainly to bleeding (diffusion of small molecules of the liquid component of silicone
through the intact shell), capsular contracture (shrinkage of the fibrous capsule, notable
as an apparent hardening of the breast) and rupture of the shell (phenomenon that can be
due to handling and trauma).

In subsequent debates between the Commission, European Parliament and national
authorities, a widely accepted consensus was generated in favour of a Community wide
policy under which the present
legal framework would be maintained, but critical
specific measures would be introduced to increase and improve information for patients,
tracking and surveillance, quality control and assurance, and key research.

The present Communication gives a follow-up to this consensus and sets out the various
measures both at Community and at national level that should be taken to address the
issues raised. These relate to the requirements in relation to breast implants themselves
and accompanying measures, not directly related to Community legislation on breast
implants, but necessary to provide an appropriate health protection.

This Communication deals only with breast implants. Throughout this communication
reference is made to women, although men may undergo similar surgery.

2.

DIRECTIVE 93/42/EEC AND ITS APPLICATION TO BREAST IMPLANTS

Breast implants are covered by Directive 93/42/EEC on medical devices 2 as modified by
Directives 98/79/EC 3 and 2000/70/EC 4, hereafter the Directive. The Directive contains
the essential requirements, in terms of quality and safety, which medical devices like

1

2

3

4

Health risks posed by silicone implants in general, with special attention to breast implants.
PE 168.396/Fin.St/rew; http://www.europarl.eu.int/stoa/publi/pdf/99-20-02_en.pdf.
OJ L 169, 12.7.1993.
OJ L 331, 7.12.1998.
OJ L 313, 13.12.2000.

3

breast implants have to meet, in order to ensure a high level of health protection. These
essential requirements are supported by harmonised standards, presenting technical
options to meet those essential requirements. The Directive also contains obligations
imposed on the manufacturer regarding labelling and information provided to the patient
and the physician.

The Directive defines four classes of medical devices (I, IIA, IIB and III), that determine
the various conformity assessment procedures to be followed for medical devices. Breast
implants are class IIB.

In order to ensure a consistent
Commission.

implementation of the Directive’s provisions,

the

• Considers that

the applicable essential

including provisions on
information and labelling, and the applicable provisions on clinical evaluation in
relation to breast implants, are to be applied by taking into consideration the elements
contained in Annex I to this Communication.

requirements,

• Will submit, in conformity with the provisions of Directive 98/34/EC 5, a mandate to
CEN, inviting CEN to reconsider the European standard EN 13350 on breast implants
in the light of this Communication.

• Will present, on the basis of Article 7 of Directive 93/42/EEC, a decision under which
breast implants, by way of derogation to the general classification rules, will be Class
III products, in order to ensure that, in the framework of a full quality assurance
system, the technical file is explicitly the subject of an approval by the Notified Body.

3.

CONTENT OF INFORMED PATIENT CONSENT

it has become clear

Throughout
the debate with the European Parliament and national authorities, and
that measures applicable
through discussions with women,
exclusively to the technical requirements in relation to breast implants are insufficient to
provide the best guarantees for health protection. Implants,
like any other surgical
interventions, can present side effects. Patients can react differently to interventions or to
the implants. Women should be aware that breast implants have to be replaced after a
time period that will be different from one person to the other. Because the benefits of
breast implantation tend to be of a subjective nature, it is particularly important for
women to be adequately informed about the associated risks, so that they can balance
these against their personal assessment of the benefits.

The Commission considers therefore of utmost importance that, before the intervention,
women receive all appropriate information in relation to potential benefits and risks of
surgical intervention and breast implants.

Therefore, bearing in mind the provisions of article 152 of the Treaty, the Commission

• Invites Member States, in consultation with all interested parties, including patient
organisations and support groups, to adopt measures implementing, at national level, a
system of adequate and comprehensive patient information followed by documenting

5

OJ L 204, 21.7.1998.

4

in writing the Patient’s Consent. The consultation procedure may include the
provision of a ‘cool off period’ and also recommendations on minimum age for the
procedure. It draws the attention to the elements contained in Annex II, that might
constitute a basis for action at national level.

• Invites Member States to ensure, as part of a policy on information to women
interested in undergoing a breast implant operation, that in the light of inherent risks
related to breast
these products provides balanced
information, and that the advertising also suggests that women seek appropriate
independent advice, e.g. consult their physician.

implants, advertising for

4.

RESEARCH AND DEVELOPMENT; INNOVATION

The Commission acknowledges the importance to be attached to a continuous search for
improvement in the clinical performance of breast implants, to improve the knowledge of
the quality of breast implants, to increase the knowledge of short and long-term effects
on health of breast implants and to the knowledge of side effects.

An efficient policy in this field should be based on a number of elements, part of which
are already contained in Directive 93/42/EC 6:

• Before breast implants are placed on the market, manufacturers must collect clinical
data on the characteristics and performance of the product. Annex I indicates the way
the Commission expects manufacturers, notified bodies and national authorities to
implement the Directive’s provisions in relation to pre-clinical data and clinical
evaluation.

• Once breast

implants have been placed on the market, or have been implanted,
manufacturers must keep up to date a systematic procedure to review experience
gained from devices in the post-production phase including prospective clinical
evaluations and implement appropriate means to apply any necessary corrective
action. The Commission invites manufacturers, notified bodies and national
authorities to take due account of the relevant Directive’s provisions.

• In accordance with the Directive, manufacturers must notify the competent authorities
of incidents 7 as indicated in the Directive. Member States must take steps to ensure
that such information is recorded and evaluated centrally. Data thus obtained will be
part of the European database, currently being set up under the Directive.

• Good Medical Practice requires that women, having received a breast implant, are
medically followed over a long period of time, to record the effect on health, and to
monitor long-term secondary effects. The Commission invites Member States to
verify with the medical profession mechanisms under which such monitoring can best
take place.

6

7

OJ L 169, 12.7.1993.
Any malfunction or deterioration in the characteristics and/or performance of a device, as well as
any inadequacy in the instructions for use which might lead to or might have led to the death of a
patient or user or to a serious deterioration in his state of health; any technical or medical reason
connected with the characteristics or performance of a device leading for the reasons referred to
above to systematic recall of devices of the same type by the manufacturer.

5

• The Commission invites Member States to examine the need and possibility to set up,
with due respect for confidentiality and the protection of privacy, national registers for
breast implantation that should constitute the basis for traceability and long term
research on breast implants.

• The Commission is aware that Member States and third countries have launched vast
research programs and reviews, such as the UK 1998 Report on Silicone breast
implants by Independent Review Group. The Commission will regularly discuss the
outcome of studies in the expert meetings it has with national authorities and
manufacturers.

5

MONITORING OF POLICY MEASURES

The Commission invites Member States to transmit to the Commission the national
measures adopted in relation to this Communication. It will regularly examine, with
national authorities, the impact of the measures promoted by this Communication.

6

Annex 1

ESSENTIAL SAFETY REQUIREMENTS AND CONFORMITY ASSESSMENT
SCHEMES OF DIRECTIVE 93/42/EEC ON MEDICAL DEVICES IN RELATION TO
BREAST IMPLANTS

I.

INTRODUCTION

This annex refers to the essential requirements laid down in Annex I of Directive
93/42/EEC and the applicable provisions on conformity assessment of the said
Directive, with a view to specify relevant Community provisions applying to breast
implants.

Regarding Annex I of the Directive, this communication refers, in particular, to the
general requirements under section I, the requirements on chemical, physical and
biological properties under point 7, section II, as well as requirements on information
supplied by the manufacturer under point 13, section II.

Regarding conformity assessment schemes, particular attention is given to the
clinical evaluation as defined under section 1 of Annex X of Directive 93/42/EEC.

In order to ensure a consistent and correct application of the provisions referred to
above in relation to these medical devices, the legislated requirements are to be
understood along the following lines.

II.

GENERAL REQUIREMENTS

Breast implants must be designed and manufactured in such a way that, when used
under the conditions and for the purposes intended, they will not compromise the
clinical condition,
the safety or the health of patients. Any residual risks or
undesirable side-effects that may be associated with their use must constitute
acceptable risks when weighed against the benefits to the patient taking into account
their benefit is primarily deemed to be aesthetic and psychological in nature, whether
the application is for reconstructive and/or cosmetic purposes.

When designing breast implants the manufacturer must perform a risk analysis to
ensure that all known and anticipated hazards are clearly identified and take all
appropriate and well documented measures to eliminate or reduce risks as far as
practicable.

Risk analysis and conformity evaluation shall be performed on the filler material, the
shell and the breast implant.

The main questions regarding the use of breast implants are:

–

–

–

the rate of rupture;

the rate of capsular contracture;

potential for migration of the filler;

7

–

bleed of the filler.

Specific attention must be paid to ensure that the clinical condition and safety of the
patient
is not compromised during the expected lifetime of the device under
conditions of normal use.

III.

PRE-MARKET ASSESSMENT

The manufacturer shall address in his assessment the items enumerated below. He
shall evaluate the data and submit his design specifications to the Notified Body
concerned for evaluation in accordance with the applicable assessment procedures.
The data obtained shall be taken into account in the risk analysis.

1.

Design attributes

The following factors shall be taken into account:

–

–

–

–

–

–

materials and their biocompatibility,
products from materials used;

including wear and degradation

physical, mechanical and chemical properties of materials taking into
account effect of manufacturing processes;

extent and effects of leakage and/or diffusion of filler substances through
an intact shell (bleed);

ability to detect rupture;

compatibility between the implant and body tissues;

ability to implant, to remove and to replace the implant.

2.

Pre-clinical data

Materials used for implants and coatings for the manufacture of breast implants
shall be selected with regard to properties required for the intended purpose of
the implant, taking into account the effects of manufacturing processes on
materials and the possible reactions of the device after implantation. The effect
of ageing on the chemical, biological and mechanical properties of the
materials shall be investigated.

A comprehensive pre-clinical
evaluated covering the points specified hereafter.

technical dossier shall be established and

In particular, in vivo studies may be necessary to investigate the way the body
toxic hazards
handles the filler materials and to characterise potential
(including immunotoxicity and reproductive toxicity) arising from chronic
exposure.

8

A. Materials and components

A.1. Chemical analysis

a)

Shell material, silicone elastomer or coated materials

An analysis of the extractable or releasable chemicals (especially
low molecular weight materials characterisation and quantification)
is necessary for the assessment of the safety of the device.

b)

Filler materials

term stability data,

A detailed chemical characterisation of the filler material shall be
established.
Long
physiological
conditions, and accelerated ageing studies shall be provided to
demonstrate the effects of time and temperature on the physical and
chemical characteristics of the device.

established

under

A.2. Toxicology

The local and systemic toxicity of any substance introduced into the body by
the breast implant shall be assessed.

The toxicological evaluation shall be based on the chemical characterisation
and toxicokinetics of
the materials, available scientific data addressing
toxicological hazards or risks and, where necessary, specific testing.

The evaluation shall address the potential for short-term and long-term effects,
including cytotoxicity, haemo-compatibility, genotoxicity, immunotoxicity and
other forms of systemic toxicity, reproductive toxicity and carcinogenicity.
This evaluation shall be taken into account in the risk analysis (see Section II,
general requirements).

Knowledge of the toxicokinetics of potentially toxic or reactive ingredients or
degradation products is necessary when these could be released into the body
in substantial quantities following implantation. Information on distribution,
transformation and elimination applicable to the route of exposure is thus
necessary.

A.3. Mechanical properties

All testing shall be performed on finished sterilised devices or components.

a)

Cohesivity of silicone gel

Cohesivity testing shall be performed to measure both the
rheological properties and the integrity of the gel in order to allow
optimising between clinical performance and safety.

b)

Rupture of shell

In order to ensure a sufficient low rupture risk, test data with

9

respect to ultimate elongation, tensile strength and tear resistance of
the shell material shall be considered, following appropriate test
methods. The adequacy of the pass/fail criteria adopted shall be
verified prior to testing.

B.

The shell

The bleed rate of the filler through the lastomer shell shall be determined.

Compatibility between the filler material and the shell shall be demonstrated by
providing long terms data on shell performance and integrity.

Effects of shell surface texture on surrounding tissues shall be evaluated.

Each type of patch/shell joint and valve/shell joint shall ensure an appropriate
resistance to failure.

C.

The implant

Static rupture testing, fatigue rupture testing and impact
testing shall be
performed on the device following appropriate test methods and test data
analysed so as to ensure a low rupture rate of the device during normal
conditions of use. The adequacy of the pass/fail criteria adopted shall be
verified prior to testing.

Possible reactions of implants with radiation and electromagnetic fields shall
be evaluated.

Surface abrasion/wear of the shell shall be tested by a method stimulating in
vivo conditions.

3.

Clinical evaluation

The purpose of the clinical evaluation is to estimate the frequency and rate at
which
and
ruptures/deflation of implants, occur after a correct implementation of a breast
implant.

complications,

contracture

particular

capsular

local

in

The secondary surgical procedures required for correction of complications
shall be assessed. Other complications could be detected such as post-operation
infection, folding, etc. which however are related to surgical conditions rather
that to the actual breast implant.

The clinical data shall be based upon an appropriate duration of patient follow-
up and a sufficient number of representative patients, to allow for an accurate
analysis of the results.

The clinical data provided by the manufacturer shall originate:

–

from prospective clinical

either
investigations performed with the
concerned breast implants in compliance with an appropriate programme
or,

10

–

from the literature, from previously performed clinical investigations or
data based on experience from the use of implants having the same
design parameters and performance characteristics as the breast implants
to be evaluated.

When using data from the literature, or obtained using other products, a
number of criteria must be fulfilled, namely:

–

–

Equivalence between the subject device and those that are the subject of
the reports must be demonstrated in terms of critical design parameters
and performance characteristics.

All data used must be generated from well-controlled clinical trials or
properly designed and conducted cohort or case/control studies or well-
documented case histories. Clinical data should be generated, reported
and critically assessed by appropriately experienced and knowledgeable
experts. Ideally, data should be published in peer review journals.
Evidence put together from isolated case reports, random experience,
reports lacking sufficient detail
to permit scientific evaluation or
unsubstantiated opinions is inadequate for this purpose.

The criteria for acceptance (i.e. safety and effectiveness) of clinical evaluation
shall be clearly identified in order to allow a risk/benefit assessment and to
provide evidence of the safety and the performance of the implant.

4.

Arrangements for post-market surveillance

As part of the pre-market requirements, the manufacturer must also institute
arrangements for prospective clinical evaluation of long term performance and
complication rates. These arrangements must foresee for the analysis of
capsular contracture rate, rupture rate abd systemic effects after pre-established
periods of time.

IV.

POST-MARKET SURVEILLANCE BY THE MANUFACTURER

When the pre-market evaluation of a specific breast implant has been successfully
completed, the manufacturer must implement the post-market clinical evaluation
programme for the implant concerned in line with the arrangements established
during the pre-market assessment.

V.

INFORMATION – LABELLING

The manufacturer shall supply the following information on the label or as data in
the instructions for use:

–

for the user, in particular:

–

–

a device description and indications for use;

contra-indications for implantation, if any, precautions for surgery;

11

–

–

–

–

instructions for implantation /explantation, training requirements;

training opportunities available;

effects of the implants on diagnostic techniques (e.g. mammography)

how and how often to evaluate the implant integrity;

–

the patient, an information package,

for
particular the following information:

in written form, containing in

–

–

–

–

–

potential complications and their possible resolution;

anticipated benefits and risks;

activities which could damage the implant;

possible need for device removal/replacement.

expected longevity of
implant, preferably expressed as
percentage survivorship at ten years (or earlier if ten-year information is
not yet available), in accordance with the Kaplan Meier method.

the breast

–

on the label, the following information:

–

–

–

traceability information batch code/serial numbers and expiry date;

the word “STERILE”

the words “SINGLE USE”.

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Annex 2

INFORMATION TO BE PROVIDED TO WOMEN WHO ARE CONSIDERING
RECEIVING BREAST IMPLANTS

Women who are considering receiving breast implants should receive all relevant and up to
date information allowing them to make a well-informed and considered decision, in full
knowledge of the potential risks and benefits of the intervention and the breast implants.
Women should be aware that breast implants are a long-term commitment.

As a basis for the information to be prepared at national level, meant to be provided to
women, the elements indicated hereafter might be used. They have been identified through a
comparative analysis of systems of informed patient consent, as promoted in various
countries 8, and by the European Committee on Quality Assurance and Medical Devices in
Plastic Surgery (EQUAM),

in a way that

Information should be provided exclusively in the interest of the women receiving the breast
implant,
language(s). This
information may be presented as an information pack containing information on implants,
surgery, potential effects, contra-indications, monitoring information, contact details and
information of a general nature.

is easily understandable and in the national

Given the relation between the physical and health position of women and expected benefits
or risks, the person best placed to provide this information is the physician experienced in the
field. It is their task to provide information on an objective basis, in line with medical ethics
and professional codes of practice.

This does not exclude that part of the information to be discussed between the women and the
physician has to be provided by the manufacturer, in written form, as part of their obligations
in putting the product on the market. The information provided by the manufacturer is
described in annex I section 13 of Directive 93/42/EEC and additional clarification is
provided in annex I of this communication.

This annex does not deal with issues relating to the consequences for insurance coverage or
cost.

I.

INFORMATION ON IMPLANTS

Women should receive all relevant
guidance criteria for the selection of given types of breast implants.

information on breast

implants,

including

This includes:

–

–

–

Types of implants (e.g. silicone, saline……), characteristics, differences

Status/legal position of types of breast implants

Information by the manufacturer on the product

8

In particular United Kingdom, France, Canada and the United States.

13

–

–

–

Benefits and risks, particularly rupture, bleeding, capsular contracture;
symptoms related to these risks.

Expected life-span; implant removal and implant replacement

Criteria for selection

II.

INFORMATION ON SURGERY

Women should receive all relevant information on the surgery itself. They should be
informed on the various surgery procedures and techniques, and on the limitations of
surgery. They should be aware that further surgery might be necessary, and that the
outcome may be determined by personal factors. They should be informed on follow-
up to be given to the surgery. They should have realistic expectations of outcome,
also concerning the aesthetic aspects over time.

Information should relate in particular to the following elements:

–

–

–

–

–

–

–

–

Reconstruction and augmentation procedures; what
alternatives to implants (tissue expansion….)

can be

achieved;

Selection of surgery techniques; position of implants; anesthesia

Timing of surgery

Additional surgery

Post operative care

Symptoms to be reported

Special conditions, e.g. for women with breast cancer

Health checklist to assess the risks for women.

III.

EFFECTS

Women should know about the potential effects of breast implants. This should
concern short term and long term effects. A distinction should be made about effects
on health and, as dissatisfaction with the result is an element that is found in all
current forms on Informed Patient Consent, aesthetic considerations. Women should
know that effects can be irreversible.

Special attention should be given to the following:

–

–

Short term health effects, such as bruising, pain, swelling, bleeding, infection,
nipple sensitivity, likely recovery time;

Long term health effects, such as wrinkles, folds, capsule formation, rupture
linked to the implant, calcification, symptoms to be noted;

14

–

–

–

–

–

Aesthetic effects, such as position of pockets, symmetry, appearance of scar,
displacement of the implant, dissatisfaction with result

Effect on breastfeeding

Effect on cancer detection, screening, mammography

Hypothesized risks, such as connective tissue diseases and related disorders;
symptoms, cancer, effect on children in particular through breast-feeding

Precautions to be taken (sport, driving, alcohol, smoking).

IV.

CONTRAINDICATIONS

The physicians should pay particular attention to women who are not indicated for
breast implants and to the absence of safety and effectiveness for patients with
conditions such as auto-immune diseases, conditions that
interfere with wound
healing and blood clotting, a weakened immune system, reduced blood supply to
breast tissue.

V.

MONITORING/WHO TO CONTACT

Women should be aware of the need to be closely monitored after surgery, both at
the short and at the long term. They should know the effect of breast implants on
living conditions. The physician may have to be involved.

Elements to be taken into account are:

–

–

–

–

–

–

–

Post operation monitoring

Long term monitoring

Breast self-examination

Participation in surveillance programs

Screening for rupture

Symptoms to be noted; actions to be taken

Information to the general practitioner on suggested follow up and possible
long-term health effects.

VI.

GENERAL INFORMATION

Finally,
concern:

information of a general nature should be made available. This can

–

Scientific evidence made available by public authorities on effects of breast
implants, on fillers.

15

–

–

–

–

–

R&D carried out in co-operation with or under the aegis of public authorities

Information made available to the public by manufacturers

Health organizations

Patients’ organizations

Public authorities.

16