June 2004 

Dear Reader: 

The Food and Drug Administration (FDA) is pleased to provide you the newly revised 

“FDA Breast Implant Consumer Handbook – 2004.” This replaces the previous version 

of the handbook entitled, “Breast Implants – An Information Update – 2000.” 

This handbook contains the latest information about breast implants to assist you in 

making an informed decision about whether or not to have breast implants. It includes 

topics such as the status of breast implants, potential complications, issues to consider, 

timeline of FDA activities related to breast implants, and breast implant resource groups. 

The Consumer Affairs Staff of FDA’s Office of Health and Industry Programs (OHIP) is 

a consumer resource to answer breast implant calls and distribute this handbook. For 

specific information on how to obtain a copy of this handbook or to talk to a Consumer 

Affairs Specialist, refer to the Resource Groups section. 

This handbook, along with other breast implant information, may also be obtained by 

visiting FDA’s website at http://www.fda.gov/cdrh/breastimplants/. 

You may also be interested in joining the Breast Implant Listserv to receive emails about 

upcoming events, panel meetings, frequently asked questions, etc. associated with breast 

implants. You may join the Breast Implant Listserv by visiting FDA’s website at 

http://www.fda.gov/cdrh/breastimplants/. 

We hope the information in this handbook will be helpful to you. You may duplicate the 

information for further distribution. If you have any comments regarding this handbook, 

please email us through the link at the bottom of FDA’s website at 

http://www.fda.gov/cdrh/breastimplants/ or write to us at FDA, Office of Device 

Evaluation, Division of General, Restorative, and Neurological Devices, 9200 Corporate 

Boulevard, HFZ-410, Rockville, MD 20850. 

 Sincerely yours,

 Samie Allen

FDA Breast Implant Team Leader 

Division of General, Restorative, 

 and Neurological Devices 

Office of Device Evaluation 

Center for Devices and Radiological Health 
TABLE OF CONTENTS

GLOSSARY ....................................................................................................................... 1

INTRODUCTION .............................................................................................................7

DEVICE DESCRIPTION...............................................................................................10

Saline-Filled Breast Implants.........................................................................................11

Silicone Gel-Filled Breast Implants...............................................................................12

Alternative Breast Implants............................................................................................13

STATUS / AVAILABILITY...........................................................................................14

Saline-Filled Breast Implants.........................................................................................14

Silicone Gel-Filled Breast Implants...............................................................................15

Alternative Breast Implants............................................................................................16

LOCAL COMPLICATIONS & REOPERATIONS....................................................17

Reoperation.....................................................................................................................19

Removal..........................................................................................................................20

Rupture/Deflation...........................................................................................................22

Capsular Contracture......................................................................................................28

Breast Pain......................................................................................................................29

Nipple and Breast Sensation Changes............................................................................30

DISEASES........................................................................................................................32

Connective Tissue Diseases (CTDs) and Related Disorders .........................................32

Cancers...........................................................................................................................35

Neurological Symptoms/Diseases..................................................................................36

SPECIFIC ISSUES TO CONSIDER.............................................................................37

Mammography ...............................................................................................................37

Breast Feeding................................................................................................................39

Effects on Children.........................................................................................................39

Suicide ............................................................................................................................40

Gel Bleed ........................................................................................................................41

Platinum..........................................................................................................................41

Silicone Sensitivity.........................................................................................................42

Polyurethane Foam-Coated Breast Implants..................................................................43

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Trilucent Breast Implants............................................................................................44
BREAST IMPLANT SURGERY & RELATED ISSUES ...........................................46

Choosing a Surgeon........................................................................................................46

Choosing an Implant.......................................................................................................47

Choosing the Surgical Incision Site ...............................................................................48

Choosing the Type of Implant Placement ......................................................................49

General Description of Breast Implant Surgery.............................................................50

After the Surgery ............................................................................................................51

Choices in Reconstructive Procedures...........................................................................52

Breast Reconstruction with Breast Implants..................................................................53

Breast Reconstruction with Tissue Flaps .......................................................................55

Questions to Ask Your Surgeon about Breast Augmentation........................................57

Questions to Ask Your Surgeon about Breast Reconstruction ......................................58

RESOURCE GROUPS ...................................................................................................59

TIMELINE OF BREAST IMPLANT ACTIVITIES...................................................62

MEDWATCH ..................................................................................................................75

FREEDOM OF INFORMATION .................................................................................76

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GLOSSARY

Below are brief definitions for some of the words used in this handbook. 

Adjunct study Clinical study for silicone gel-filled breast implant to address a public 

health need for reconstruction and revision patients. The status of the 

implants in an adjunct study is investigational. 

Asymmetry Uneven appearance between a woman’s breasts in terms of size, shape, 

or breast level.

Augmentation Includes cosmetic uses, such as to increase breast size or for ptosis 

(sagging or drooping of the breast) or asymmetry. Augmentation is one 

of three indications (clinical uses) for breast implants. 

Breast pain Pain in the nipple or breast area. See the Local Complications & 

Reoperations section for more details. 

Breast pocket A pocket surgically created to hold the implant. 

Breast tissue 

atrophy 

Thinning and shrinking of the skin. 

Calcification/ 

calcium 

deposits 

Hard lumps under the skin around the implant. These can be mistaken 

for cancer during mammography, resulting in additional surgery, either to 

biopsy the lumps or to remove the implant. 

Capsular 

contracture

Scar tissue or capsule that normally forms around the implant, which 

tightens or squeezes the implant. There are four grades of capsular 

contracture ranging from grade I (breast is normally soft and looks 

natural) to grade IV (breast is hard, painful, and looks abnormal). See the 

Local Complications & Reoperations section for more details. 

Chest wall 

deformity 

When the chest wall or underlying rib cage appears deformed following 

removal of the implants and breast tissue. 

Delayed wound 

healing 

Incision site fails to heal normally or takes longer to heal. 

Extracapsular 

rupture 

Rupture of silicone gel-filled breast implant in which the silicone gel is 

outside of the fibrous scar capsule that forms around the implant. 

1 
Extrusion Skin breakdown with the implant appearing through the skin. 

Galactorrhea Inappropriate breast milk production that may occur after breast implant 

surgery. In some cases, the milk production stops by itself or after 

receiving medicine to stop milk production. In other cases, the 

implant(s) may need to be removed to treat this complication. 

Granuloma Non-cancerous lumps that can form when certain body cells surround 

foreign material, such as silicone. Like any lump, it should be evaluated 

to distinguish it from a lump that might be cancerous. 

Hematoma Collection of blood inside a body cavity. Swelling, pain, and bruising 

may result. If a hematoma occurs, it will usually be soon after surgery; 

however, it can also occur at any time after injury to the breast. While 

the body absorbs small hematomas, large ones may require the placement 

of surgical drains for proper healing. A small scar can result from 

surgical draining. 

Iatrogenic 

injury/damage 

Injury/damage to the tissue or implant due to surgical instruments either 

during the operation, during a reoperation, during implant removal, or 

during breast procedures while the implant is in place (e.g., cyst 

aspiration or hematoma drainage). 

Infection Can occur with any surgery when wounds are contaminated with microorganisms such as bacteria or fungi. Most infections resulting from 

surgery appear within a few days to weeks after the operation. However, 

infection is possible at any time after surgery. Infections with an implant 

present are harder to treat than infections in normal body tissues. If an 

infection does not respond to antibiotics, the implant may have to be 

removed. Another implant may be placed after the infection is gone. 

Inframammary Within the breast fold. 

Inflammation/ 

irritation 

Swelling of the breast area, usually with redness. 

Intracapsular 

rupture 

Rupture of silicone gel-filled breast implant in which the silicone gel 

remains contained within the fibrous capsule. 

Investigational Not approved, in general terms. For breast implants, this means not 

PMA-approved. 

2 
Investigational 

Device 

Exemption 

(IDE) 

Clinical study performed to collect clinical data on a device to support 

approval of a marketing application. Approval of an IDE study does not

mean approval to market the implant. The status of a device in an IDE 

study is investigational. 

Local 

complications 

Complications that occur in the breast or chest area. 

Malposition/ 

displacement 

When the implant is placed incorrectly during the initial surgery or when 

the implant has moved/shifted from its original position. Shifting can be 

caused by many factors, such as gravity, trauma, poor initial placement, 

and capsular contracture. 

Mastectomy Partial or complete removal of the breast. 

Mastopexy Surgical procedure to raise and reshape sagging breasts. Women may 

also have this surgery after an implant is removed and not replaced. 

Necrosis Formation of dead tissue around the implant. Factors associated with 

increased necrosis include infection, use of steroids in the surgical breast 

pocket, smoking, chemotherapy/radiation, and excessive heat or cold 

therapy. 

Nipple/breast 

sensation 

changes 

An increase or a decrease in the sensation in the nipple or breast. This 

change can vary in degree and may be temporary or permanent. It may 

affect comfort while nursing or sexual response. See the Local 

Complications & Reoperations section for more details. 

Palpability/ 

visibility 

Palpability is when the implant can be felt through the skin. Visibility is 

when the implant can be seen through the skin, such as the valve on a 

saline-filled breast implant or the edge of an implant. 

Periareolar Around the nipple. 

Premarket 

approval 

(PMA) 

Application for marketing a device. FDA must approve the PMA for the 

device to be sold on the market in the U.S. 

3 
Prospective

study 

Study in which people are exposed to a medical intervention, such as

breast implants, and then observed over time to determine how effective 

and safe the intervention is. The outcome is not known when a 

prospective study is started. Medical evaluations are performed before 

and after the intervention so that the outcome of the intervention can be 

measured. 

Ptosis Sagging/drooping of the breast. 

Reconstruction Includes non-cosmetic uses such as post-mastectomy, a severe injury to 

the breast, a birth defect that affects the breast, or a medical condition 

causing a severe breast abnormality. Reconstruction is one of three 

indications (clinical uses) for breast implants. 

Redness/ 

bruising 

Bleeding at operative site that causes discoloration and varies in degree 

and length of time. This is expected following breast implant surgery or 

breast procedures. 

Reduction 

mammoplasty 

Surgical procedure to reduce breast size. 

Removal Removal of the implant, with or without replacement. See the Local

Complications & Reoperations section for more details. 

Reoperation Any additional surgery performed to the breast or chest area. See the 

Local Complications & Reoperations section for more details. 

Retrospective 

study 

Study that begins after a medical intervention, such as breast implant 

surgery, has occurred. Therefore, it looks backward in time at events 

complications that happened in the past. For instance, a group of women 

with breast implants may be identified and then asked to allow 

researchers to review their medical records to obtain information on 

complications that they had. Women might also be asked to respond to a 

survey or interview about whether or not they had complications with 

their implants. The problem with this type of study is that it assumes that 

if there was a problem, it would be in the medical record or that someone 

would remember it accurately. 

Revision This is replacement of an existing breast implant. Revision is one of

three indications (clinical uses) for breast implants. 

4 
Rupture/ 

deflation 

Hole or tear in the shell of the implant that allows for loss of the filler 

material from the shell. See the Local Complications & Reoperations 

section for more details. 

Scarring Formation of tissue at the incision. All wounds heal by the formation of 

a scar. The degree of scarring varies from person to person, and skin

type is an important factor for the development of scars. If the scarring 

becomes irregular and raised, it is called hypertrophic scarring. This may 

leave a visible, permanent scar. The keloid, a severe type of hypertrophic 

scar, generally does not fade or flatten with time. 

Seroma Collection of the watery portion of the blood around the implant or 

around the incision. Swelling, pain, and bruising may result. While the 

body absorbs small seromas, large ones will require the placement of 

surgical drains for proper healing. A small scar can result from surgical 

draining. 

Silent rupture Rupture of a silicone gel-filled breast implant that happens without a 

visible change or feel by the woman and is not evident by a physical 

examination by the doctor. 

Silicone Silicone is a man-made material that can be found in several forms such 

as oil, gel, or rubber (elastomer). The exact make-up of silicone will be 

different depending on its use. See the Device Description section for 

more details. 

Subglandular When the implant is placed under and within the breast glands but on top 

of the chest muscles. 

Submuscular When the implant is placed underneath the chest muscles. 

Toxic Shock 

Syndrome 

Rare, but life-threatening bacterial infection that may occur after surgery. 

Symptoms include sudden fever, vomiting, diarrhea, fainting, dizziness, 

and sunburn-like rash. A doctor should be seen immediately for 

diagnosis and treatment if toxic shock syndrome is suspected.

Transaxillary Under the arm. 

Unsatisfactory 

style/size 

Patient or doctor is not satisfied with the overall look based on the style 

or size of implant used. 

5 
Wrinkling/ 

rippling 

Wrinkling of the implant that can be felt or seen through the skin. 

510(k) Application for marketing a device. In the past, breast implants were 

reviewed under the 510(k) process. However, they are now reviewed 

under the PMA process. 

6 
INTRODUCTION

The three basic types of breast implants are saline-filled, silicone gel-filled, and 

alternative (e.g., soybean oil) implants. Breast implants are designed for treatment of 

augmentation, reconstruction, and revision patients. While many women believe breast 

implants cause illnesses, such as autoimmune disease, this is not proven at this time. 

However, most women with breast implants will experience local complications, such as 

pain, capsular contracture, and rupture/deflation. You may need to have nonsurgical 

treatments or reoperations to treat local complications. Breast implants do NOT last a 

lifetime. You should be prepared for long-term follow-up, reoperations to treat 

complications, and personal financial costs. 

Before you make your decision whether or not to get breast implants, it is very important 

that you: 

• read the information in this handbook 

• read the patient labeling for the approved saline-filled breast implants at FDA’s 

website (http://www.fda.gov/cdrh/breastimplants/) to learn about the types and 

rates of complications seen with breast implants 

• read the specific patient labeling or informed consent documents for the breast 

implants for which you are gathering information1

• collect specific information from your insurance company and your doctor to

estimate personal financial costs (see below) 

• have a realistic expectation of the outcome (see below). 

 

7 

1

 Patient labeling is the general term used for the patient information provided for approved breast implants. An

informed consent document, on the other hand, is the format for providing patient information to all investigational 

(not approved) breast implants under clinical studies. Refer to the Status/Availability section for more details. 
After obtaining all of the information that is recommended and getting answers to your 

questions, you should give yourself adequate time to determine whether or not to get 

breast implants. 

Personal Financial Costs – Breast implant surgery and treatment of complications 

may not be covered by your health insurance. Typically, insurance companies will not

cover breast augmentation or any reoperations and additional doctor visits following 

augmentation. However, most insurance companies cover the first breast reconstruction 

operation. Insurance coverage for reoperation procedures or additional doctor visits 

following reconstruction may not be covered, depending on your insurance policy. 

Aside from insurance coverage specific to your surgery, you need to find out about how 

breast surgery will affect your health insurance, as a whole. For some women, 

companies may increase premiums, drop coverage, or deny future coverage 

following breast implant surgery or following complications from the breast 

implants or surgery. Policies on coverage may also change from year to year. 

Before surgery, be sure to get, in writing, answers from your insurance company to the 

following questions, at a minimum: 

• Does my policy cover the costs of the implant surgery, the implant, the anesthesia, 

and other related hospital costs? To what extent? 

• Does it cover removal and replacement of the implants if this becomes necessary? 

To what extent? 

• Does it cover the cost of detecting or treating a complication as a result of either 

the implant or the reconstruction? To what extent? 

• Will there be an increase in my insurance premium? To what extent? 

• Will future coverage be affected? To what extent? 

8 
In addition to collecting information from your insurance company, you should also ask 

your doctor to provide cost information such as: 

• What are the costs of getting breast implants (the implants, the anesthesia, the 

surgery, etc.)? 

• What are the costs for follow-up visits? 

• What are the costs for detecting or treating a complication, especially treatment 

that involves a reoperation, such as implant removal with or without replacement? 

• What is the specific manufacturer warranty for the implants that you are gathering 

information on? 

Realistic Expectations: Your decision whether or not to get breast implants should be 

also based on realistic expectations of the outcome. There is no guarantee that your 

results will match those of other women. Your results will depend on many individual 

factors, such as your overall health (including age), chest structure, breast/nipple shape 

and position, skin texture, healing capabilities (which may be slowed by radiation and 

chemotherapy treatment, smoking, alcohol, and various medications), tendency to bleed, 

prior breast surgery(ies), surgical team’s skill and experience, type of surgical procedure, 

and type and size of implant. 

9 
DEVICE DESCRIPTION

Breast implants may vary in shell surface (smooth versus textured), shape (round or 

shaped), profile (how far it sticks out), volume (size), and shell thickness. The primary 

parts of most breast implants are a shell (otherwise known as the envelope or lumen), a 

filler, and a patch to cover the manufacturing hole. 

With respect to the shell design, while most breast implants are single lumen (just the 

shell), some breast implants are double lumen (one shell inside another shell). With 

respect to the filler, some breast implants are manufactured with a fixed volume of filler, 

some are filled during the operation, and some allow for adjustments of the filler volume 

after the operation. 

It should be noted that tissue expanders, which are silicone shells filled with saline, are 

regulated by FDA in a different way than breast implants. This is because tissue 

expanders are intended for general tissue expansion for a maximum of 6 months, after 

which, they are to be removed. Because of this, the design specifications (e.g., thinner 

shell) and preclinical testing recommendations are different for tissue expanders than for 

breast implants. Tissue expanders are not to be confused with the third type of double 

lumen silicone gel-filled breast implants described in the Silicone Gel-Filled Breast 

Implants section below. The third type of double lumen silicone gel-filled breast 

implant is a permanent implant (not intended to be removed) that allows for limited tissue 

expansion but is regulated by FDA as a breast implant. See that section for more details. 

 

Below is information specific to saline-filled, silicone gel-filled, and alternative breast 

implants. 

10 
Saline-Filled Breast Implants 

The three types of saline-filled breast implants are as follows: 

• One type is a single lumen implant that is filled during the operation with a fixed 

volume of saline through a valve. There are no adjustments of the saline volume 

after the operation. 

• A second type is a single lumen implant that is filled during the operation with 

saline through a valve. This type of implant allows for adjustments of the saline 

volume after the operation. 

• A third type is a single lumen implant that is prefilled by the manufacturer with a 

fixed volume of saline. There are no valves for filling during the operation or for 

adjustments of the saline volume after the operation. 

The silicone rubber shell for a saline-filled breast implant has the following general

composition: 

• cured polymeric (large) silicones 

•

•

•

•

approximately 20% of finely powdered silica that is tightly bound to the silicone 

polymers 

small amounts of smaller silicones 

minute amounts (parts per million) of metals, including a metal catalyst (usually 

tin, zinc, or platinum) (A catalyst is something that causes a change in 

material.) 

traces of readily evaporating materials (volatiles), such as xylene and other 

organic compounds. 

11 
The filler is sterile saline that should conform to United States Pharmacopeia (USP)

standards for Normal Physiological Saline (injection grade).2

Silicone Gel-Filled Breast Implants 

The three types of silicone gel-filled breast implants are as follows: 

• One type is a single lumen implant that is prefilled by the manufacturer with a 

fixed volume of silicone gel. 

• A second type is a double lumen implant with (1) an inner lumen prefilled by the 

manufacturer with a fixed volume of silicone gel and (2) an outer lumen that is 

filled during the operation with a fixed volume of saline through a valve. 

• A third type is a double lumen implant with (1) an outer lumen prefilled by the 

manufacturer with a fixed volume of silicone gel and (2) an inner lumen that is 

filled during the operation with saline through a valve. This type of implant 

allows for adjustments of the saline volume after the operation. 

A silicone gel-filled breast implant has a silicone rubber shell with the same general 

composition as shown in the Saline-Filled Breast Implants section above. 

The filler is silicone gel that has the general composition of: 

•

•

•

 

silicone oil 

cured polymeric (large) silicones 

small amounts of uncured large and smaller silicones 

2

 As a note, one concern that relates specifically to saline-filled breast implants is the potential for the saline to

become contaminated (not sterile) with fungus or bacteria and then released into the woman's body if her implant 

ruptures/deflates or if the valve leaks. However, saline-filled implants are now generally filled from a bag and 

tubing rather than from an open bowl, and this procedure may reduce the risk of this complication. 

12 
minute amounts (parts per million) of metals, including a metal catalyst (usually 

platinum). (A catalyst is something that causes a change in material.) 

•

Alternative Breast Implants 

An alternative breast implant typically has a silicone rubber shell with a filler other than 

saline or silicone gel. The filler material may or may not be a gel. An alternative breast 

implant may also have an alternative shell other than one made from silicone rubber. 

13 
STATUS / AVAILABILITY

Saline-Filled Breast Implants 

Prior to August 1999, saline-filled breast implants were sold on the market either as 

preamendments devices (they were on the market prior to May 1976) or as 510(k)-

cleared devices. In August 1999, FDA issued a regulation that required that all salinefilled breast implants be PMA-approved to be sold on the market. However, those 

companies that had a preamendments or 510(k)-cleared saline-filled breast implant and 

submitted their PMA within 90 days of the August 1999 regulation were allowed to keep 

their device on the market until the final decision/actions were made in May 2000. Since 

May 2000, a saline-filled breast implant must be PMA-approved to be sold on the 

market.3

 

On May 10, 2000, FDA approved Mentor Corporation’s and Inamed Corporation’s 

(formerly McGhan Medical) saline-filled breast implant PMAs. As of the date of this 

handbook, these are the only two companies with PMA-approved saline-filled breast 

implants. 

Except for two PMA-approved saline-filled breast implants, all other saline-filled 

breast implants are considered investigational devices because they are not PMAapproved. For a woman to receive an investigational saline-filled breast implant 

in the U.S., she must enroll in an investigational device exemption (IDE) study. 

An IDE study is a clinical study that must be reviewed and approved by FDA to help 

assure that the resulting data will be meaningful and that patients will not be exposed to 

unreasonable risks. IDE studies may include augmentation, reconstruction, and/or 

revision patients. The number of patients and the number of sites are limited in IDE 

 

14 

3

A completed product development protocol (PDP) application is an alternative to an approved PMA for all types of 

breast implants. However, to date, no companies have pursued the PDP route to marketing for these devices; thus,

PDPs are not discussed further in this handbook. 
studies. In addition, each woman who participates in an IDE study must give informed 

consent.4

 The safety and effectiveness data collected in an IDE study are used to support 

a future PMA. 

Silicone Gel-Filled Breast Implants 

Prior to 1991, silicone gel-filled breast implants were sold on the market as either 

preamendments devices (they were on the market prior to May 1976) or as 510(k)-

cleared devices. In April 1991, FDA issued a regulation that required that all silicone 

gel-filled breast implants be PMA-approved to be sold on the market. However, those 

companies that had a preamendments or 510(k)-cleared silicone gel-filled breast implants 

and submitted their PMA within 90 days of the April 1991 regulation were allowed to 

keep their device on the market until the final decision/actions were made in April 1992. 

Since April 1992, a silicone gel-filled breast implant must be PMA-approved to be sold 

on the market. 

As of the date of this handbook, no company has PMA approval for a silicone gelfilled breast implant. Therefore, all silicone gel-filled breast implants are 

considered investigational. For a woman to receive a silicone gel-filled breast 

implant in the U.S., she must enroll in an IDE study or an adjunct study.

An IDE study is described in the Saline-Filled Breast Implants section above. 

An adjunct study is different from the IDE study in terms of its purpose and study design. 

In April 1992, FDA determined that the silicone gel-filled breast implant PMAs 

submitted in 1991 did not include adequate safety data to support PMA approval. 

However, FDA believed that there was a public health need to have breast implants 

 

15 

4

 Note that the informed consent document required for a patient to participate in an IDE study should not be 

confused with a standard surgical consent form that a hospital requires to be signed by any surgical patient.
available for reconstruction and revision patients. Therefore, companies that had not 

withdrawn their PMAs prior to the April 1992 decision were given the opportunity to 

submit an adjunct study protocol, for FDA approval, to address the public health need. 

Only Mentor Corporation and Inamed Corporation received approvals for their adjunct 

studies. 

Adjunct studies are limited to reconstruction and revision patients. Women who want 

silicone gel-filled implants for augmentation (cosmetic reasons) cannot be enrolled in an 

adjunct study. New reconstruction and revision patients are continuously being enrolled 

in the adjunct studies because there is no limit on the number of patients or the number of 

sites. Each woman who participates in an adjunct study must give informed consent.5

 

The safety data collected in an adjunct study are used as supplemental data to support a 

future PMA. 

Alternative Breast Implants 

All alternative breast implants are reviewed through the PMA process because they are 

post-amendments devices (not on the market prior to May 1976). As of the date of this 

handbook, there are no alternative breast implants approved for marketing. Therefore, all 

alternative breast implants are considered investigational devices. To receive an 

alternative breast implant in the U.S., you must enroll in an IDE study (see the SalineFilled Breast Implant section above). 

Refer to the Timeline of Breast Implant Activities section to see which companies have 

IDE studies for their breast implants. 

 

16 

5

 Note that the informed consent document required for a patient to participate in an adjunct study should not be

confused with a standard surgical consent form that a hospital requires to be signed by any surgical patient.
LOCAL COMPLICATIONS & REOPERATIONS

The Institute of Medicine (IOM) completed its independent review of past and ongoing 

scientific research of silicone [both saline-filled and silicone-gel filled] breast implant 

safety in June 1999.6 Below are some of the major findings from the IOM report. 

• Local complications are the primary safety issue with breast implants because 

they are frequent enough to be a concern. 

• Local complications accumulate over the lifetime of the implant, and they have 

not been well studied. 

• Information on local complications is crucial for women deciding whether or not 

they want breast implants. 

Key points to consider whether you are undergoing breast augmentation, 

reconstruction, or revision: 

• Breast implants will not last a lifetime. Either because of rupture or other 

complications, you will likely need to have the implants removed. 

• You are likely to need additional doctor visits and reoperations because of one 

or more complications over the course of your life. 

• You are likely to have the implants removed, with or without replacement, 

because of one or more complications over the course of your life. 

• Many of the changes to your breast following implantation may be cosmetically 

undesirable, as well as irreversible (cannot be undone). 

 

17 

6

 Safety of Silicone Breast Implants. Institute of Medicine National Academy Press, Washington, D.C. 2000. {IOM 

Report}. Also available through IOM website at www.iom.edu.
• If you later choose to have your implants removed, you may experience 

unacceptable dimpling, puckering, wrinkling, loss of breast tissue, or other 

undesirable cosmetic changes of the breast. 

Potential local breast implant complications are bulleted below. You may need nonsurgical treatments or reoperations (including removal of your implant) to treat any of 

these local complications. Potential local complications include, but are not limited to: 

• Asymmetry • Inflammation/irritation 

• Breast pain • Malposition/displacement 

• Breast tissue atrophy • Necrosis 

• Calcification/calcium deposits • Nipple/breast sensation changes

• Capsular contracture • Palpability/visibility

• Chest wall deformity • Ptosis 

• Delayed wound healing • Redness/bruising 

• Extrusion • Rupture/deflation 

• Galactorrhea • Scarring 

• Granuloma • Seroma 

• Hematoma • Unsatisfactory style/size 

• Iatrogenic injury/damage • Wrinkling/rippling 

• Infection, including Toxic Shock 

Syndrome 

Refer to the Glossary at the front of this handbook for a brief definition of each of the 

complications bulleted above. If you need more explanation, you should ask your doctor 

before you make your decision whether or not to get breast implants. 

Below is a more detailed discussion of reoperation, removal, and the four bolded local 

complications bulleted above. 

18 
Reoperation 

As stated above, it is likely that you will need to have one or more reoperations over the 

course of your life because of local complications from breast implants. 

Reasons for reoperations could include any of the potential local complications bulleted 

above, such as capsular contracture, wrinkling, asymmetry, rupture/deflation, implant 

malposition, etc. 

The type of surgical procedure(s) performed during the reoperation depends on the local 

complication involved. More than one procedure may be performed in a single 

reoperation. Examples of the types of surgical procedures that may be performed in a 

reoperation include: 

• implant removal with or without replacement 

• capsule procedure (e.g., removal or surgical release of the capsule) 

• scar or wound revision (e.g., surgical removal of excess scar tissue) 

• drainage of a hematoma (e.g., inserting a needle or tube through the skin to drain 

the collection of blood) 

• repositioning of the implant (e.g., surgically opening the incision and moving 

the implant) 

• biopsy/cyst removal (e.g., inserting a needle through the skin or cutting through 

the skin to remove a lump). 

Multiple reoperations to either improve the appearance of the breasts, to remove 

ruptured/deflated implants, or both may result in an unsatisfactory cosmetic outcome. 

19 
A retrospective study by Gabriel, et al. showed that 24% of women with breast implants 

had complications resulting in a reoperation during the first five years after implantation 

(silicone and saline implants were studied together).7

 According to this study, about 1 in 

3 women getting breast implants for reconstruction needed a reoperation within five 

years, and about 1 in 8 women getting breast implants for augmentation needed a 

reoperation within five years. 

Prospective studies of saline-filled breast implants approved by FDA in May 2000 

showed reoperation rates of 13-21% at 3 years and 20-26% at 5 years for augmentation 

patients. The same studies showed reoperation rates of 39-40% at 3 years and 43-45% at 

5 years for reconstruction patients.8,9 

Removal 

Removal of the implant(s), with or without replacement, is one type of surgical procedure 

that may be performed in a reoperation. As stated above, you are likely to have your 

implant removed at some time over the course of your life because of one or more local 

complications. 

Reasons for removal could include any of the potential local complications bulleted 

above, such as capsular contracture, wrinkling, asymmetry, unsatisfactory size/style, etc. 

Many women decide to have the implants replaced, but some women do not. Women 

who do not have their implants replaced may have cosmetically undesirable dimpling, 

puckering, or sagging of the breast following removal of the implant, or both. Recall that 

some health insurance companies may not cover implant removal or implant replacement 

even though the first implant surgery was covered by health insurance. 

 

7 Gabriel SE, Woods JE, O’Fallon WM, Beard CM, Kurland LT, Melton LJ. Complications leading to surgery after 

breast implantation. New Engl J Med 1997; 336:679-682. 8

 Inamed patient labeling at FDA’s website at http://www.fda.gov/cdrh/breastimplants/. 

20 

9

 Mentor patient labeling at FDA’s website at http://www.fda.gov/cdrh/breastimplants/. 
Prospective studies of saline-filled breast implants approved by FDA in May 2000 

showed implant removal rates of 8% at 3 years and 12-14% at 5 years for augmentation 

patients. The same studies showed implant removal rates of 23-27% at 3 years and 28-

30% at 5 years for reconstruction patients.10,11 

In a retrospective study of augmentation patients with silicone gel-filled breast implants, 

303 of 907 (33%) of women reported that they had at least one reoperation in which their 

implant(s) were removed or replaced.12 The average time to removal, as reported by 

those who remembered the date of their surgery, was 11.5 years. 

Photograph 1 below shows the same 29-year-old woman in Photograph 3 (see the 

Capsular Contracture subsection below) one year after removal of her silicone gelfilled breast implants without replacement.13 Women with large implants, particularly 

those inserted subglandularly (under and within the breast glands but on top of the chest 

muscles), may have a major cosmetic deformity if they choose not to replace them or to 

undergo additional reconstructive surgery. 

Photograph 1: Implant removal without replacement in augmentation patient. 

 

10 Inamed patient labeling at FDA’s website at http://www.fda.gov/cdrh/breastimplants/. 11 Mentor patient labeling at FDA’s website at http://www.fda.gov/cdrh/breastimplants/. 12 Brown SL, Pennello G. Replacement surgery and silicone gel breast implant rupture: Self-report by women after 

mammoplasty. Journal of Women’s health & Gender Based Medicine, 2002;11:255-264. A summary of the 

findings of this study is also available on FDA’s website at http://www.fda.gov/cdrh/breastimplants/. 

21 

13 Photograph courtesy of Walter Peters, Ph.D., M.D., F.R.C.S.C., University of Toronto. 
Rupture/Deflation 

Breast implants do not last a lifetime. Some breast implants rupture/deflate14 in the first 

few months after being implanted and some deflate after several years. Others may take 

10 or more years to rupture/deflate. 

The following surgical practices are contraindicated (not recommended) for the approved 

saline-filled breast implants because they are known to cause rupture/deflation: 

• closed capsulotomy (technique used to relieve capsular contracture involving 

manually squeezing the breast to break the hard capsule) 

• placement of drugs/substances inside the implant other than sterile saline 

• any contact of the implant with Betadine®15

• injection through the implant shell 

• alteration of the implant 

• stacking of the implants (more than one implant per breast pocket). 

In addition to the surgical practices above that have been shown to cause 

rupture/deflation of saline-filled breast implants, there are other reasons for 

rupture/deflation of breast implants. Companies are currently studying what these other 

reasons are. 

 

14 Although the term rupture is used for all types of implants, the term deflation is typically used only for salinefilled breast implants. 

22 

15 Betadine is a registered trademark of Purdue Frederick Company.
Some possible reasons for rupture/deflation of breast implants include: 

• normal aging of the implant 

• damage by surgical instruments 

• too much handling during surgery 

• damage by procedures to the breast, such as biopsies and fluid drainage 

• compression during mammographic imaging 

• stresses such as trauma or intense physical pressure 

• capsular contracture 

• overfilling or underfilling of saline-filled breast implants 

• placement through an umbilical (belly button) incision site because it involves 

too much handling of the implant. 

Doctors usually recommend removal of the implant if it has ruptured, regardless of 

whether it is saline-filled or silicone gel-filled. 

Rupture/Deflation of Saline-Filled Breast Implants – Saline-filled breast implants 

rupture/deflate when the saline solution leaks either through an unsealed or damaged 

valve or through a break in the implant shell. Implant deflation usually happens

immediately but sometimes it happens slower over a period of days. Deflation of salinefilled breast implants is noticed by a loss of size or shape of the implant. 

23 
The IOM report16 stated that the deflation rate reported in the medical literature across 

studies was 7% at 7 years. The IOM report also stated that earlier saline-filled breast 

implant models had more frequent deflations than modern models. The IOM estimated 

that 1-3% of modern saline-filled breast implants would have ruptured by the first year 

and that this rate would increase over time. The modern models show a 5-10% rupture 

rate after 10 years, according to one study. 

Prospective studies of saline-filled breast implants approved by FDA in May 2000 

showed rupture/deflation rates of 3-5% at 3 years and 7-10% at 5 years for augmentation 

patients. The same studies showed rupture/deflation rates of 6-9% at 3 years and 8-18% 

at 5 years for reconstruction patients.17,18 

Photograph 2 below shows a 30-year-old woman’s left saline-filled breast implant 

deflation.19 The suspected cause was the leaf-valve design of the implant, which is no 

longer being used by manufacturers. 

Photograph 2: Deflation in augmentation patient. 

 

16 Safety of Silicone Breast Implants. Institute of Medicine National Academy Press, Washington, D.C. 2000. {IOM 

Report}. Also available through IOM website at www.iom.edu. 17 Inamed patient labeling at FDA’s website at http://www.fda.gov/cdrh/breastimplants/. 18 Mentor patient labeling at FDA’s website at http://www.fda.gov/cdrh/breastimplants/. 

24 

19 Photograph courtesy of Walter Peters, Ph.D., M.D., F.R.C.S.C., University of Toronto. 
Rupture/Deflation of Silicone Gel-Filled Breast Implants - Because silicone gel is 

thicker than saline, when a silicone gel-filled breast implant ruptures, the gel may remain 

contained within the fibrous capsule. This is called an intracapsular rupture. An 

intracapsular rupture is usually a silent rupture, which means that it happens without a 

visible change or feel by the woman and is not evident by a physical examination by the 

doctor. Because the woman and her doctor will not see or feel any changes with a silent 

rupture, a magnetic resonance imaging (MRI) examination is needed to determine 

whether or not a silent rupture has happened. MRI with equipment specifically designed 

for imaging the breast is currently the most sensitive method for detecting rupture of a 

silicone gel-filled breast implant in women with silent ruptures.

With some silicone gel-filled implants ruptures, women may notice a decreased breast 

size, a change in breast implant shape, hard lumps over the implant or chest area, an 

uneven appearance of the breasts, pain or tenderness, tingling, swelling, numbness, 

burning, or changes in sensation. Ruptures of this type are called symptomatic (show 

symptoms) and are usually extracapsular (gel outside the fibrous capsule). However, 

some extracapsular ruptures can be silent (show no symptoms). 

Silicone gel that escapes the scar capsule surrounding the implant may migrate away 

from the breast. The free silicone gel may cause lumps called granulomas to form in the 

breast or in other tissues where the silicone gel has migrated, such as the breast tissue, 

chest wall, armpit, or arm. Silicone gel may also migrate to distant organs such as the 

liver. Migrated silicone gel may be difficult or impossible to remove. 

The IOM report20 stated that rupture rates reported in the medical literature across studies 

ranged from 0.3-77%. This large range of rupture rates is due to the different types and 

models of implant, varying durations of implantation, different types of groups of women 

studied, and other factors. The IOM report also stated that extracapsular gel (gel outside 

 

25 

20 Safety of Silicone Breast Implants. Institute of Medicine National Academy Press, Washington, D.C. 2000. {IOM 

Report}. Also available through IOM website at www.iom.edu.
the fibrous capsule) was present in about 12-26% of gel-filled ruptures reported in the 

medical literature. The IOM estimated that less than 10% of modern silicone gel-filled 

breast implants would have ruptured by five years and that rupture rate would continue to 

increase over time. 

FDA reported a retrospective study on rupture of silicone gel-filled breast implants.21 

This study included augmentation women who had breast implants before 1988. There 

were 344 women (with 687 implants) who had a MRI examination of their breasts to 

determine whether or not there was evidence of rupture of their implants. Of the 687 

implants in the study, 378 implants (55%) were ruptured. This means that 69% of the 

344 women had at least one ruptured breast implant. Of the 265 women with at least one 

rupture, 73 (21%) had extracapsular (outside the capsule) silicone gel in one or both 

breasts. Factors that were associated with rupture included the age of the implant, the 

specific manufacturer of the implant, and the surgical placement (submuscular versus 

subglandular) of the implant. 

Marotta, et al.22 reviewed numerous publications on over 9,770 silicone implants that 

were removed and concluded that 26% of implants were ruptured by 3.9 years, 47% were 

ruptured by 10.3 years, and 69% were ruptured by 17.8 years. Marotta, et al. also 

reported that shells from removed silicone gel-filled breast implants were considerably 

weaker than shells before implantation. 

Holmich, et al. 200123 reported on a group of 271 women, with 533 augmentation breast 

implants, who had MRI evaluations for rupture. These women had breast implantation 

 

21 Brown SL, Middleton MS, Berg WA, Soo MS, Pennello G. Prevalence of rupture of silicone gel breast implants

revealed on MR imaging in a population of women in Birmingham, Alabama. American Journal of Roentgenology

2000;175:1-8. A summary of the findings of this study is also available on FDA’s website at

http://www.fda.gov/cdrh/breastimplants/. 22 Marotta JS, Goldberg EP, Habal MB, Amery DP, Martin PJ, Urbaniak DJ, Widenhouse CW. Silicone gel breast 

implant failures: Evaluation of properties of shells and gels for explanted prostheses and meta-analysis of literature 

rupture data. Ann Plast Surg 2002;49:227-247. 

26 

23 Holmich, LR, et al. Prevalence of silicone breast implant rupture among Danish women. Plast Reconstr Surg. 

2001; 108(4):848-858.
before 1996 and were randomly selected from four plastic surgery clinics in Denmark. 

The authors found that, overall, 26% of implants in 36% of the women examined were 

found to be ruptured, and an additional 6% of implants were possibly ruptured. This is 

the minimum rupture rate for this group because there were problems with performance 

of the MRI at one of the study sites. Of the ruptured implants, 22% were extracapsular, 

and these ruptures were significantly associated with a history of closed capsulotomy. 

In a follow-up study by Holmich, et al.24, this group of women had another MRI two 

years later. Over the 2-year period, the MRI evaluations showed that 17% of the 

implants were definitely or possibly ruptured.

According to the IOM report25, the diagnosis of rupture of a gel-filled breast implant is 

important because the release of silicone gel and fluid into the tissues may result in local 

complications. An intracapsular rupture may become extracapsular, and both are 

generally agreed to indicate the need for removal of the implant. The rupture rate over 

time (both intracapsular and extracapsular) of modern silicone gel-filled breast implants 

is currently not well characterized. The silent rupture rate over time is not known for 

modern silicone gel-filled breast implants. 

 

24 Holmich, LR, et al. Incidence of silicone breast implant rupture. Arch Surg. 2003; 138:801-806.

27 

25 Safety of Silicone Breast Implants. Institute of Medicine National Academy Press, Washington, D.C. 2000. {IOM 

Report}. Also available through IOM website at www.iom.edu.
Capsular Contracture 

Capsular contracture happens when the scar tissue or capsule that normally forms around 

the implant tightens and squeezes the implant. It can happen to one or both of the 

implanted breasts. 

There are four grades of capsular contracture - Baker grades I through IV. The Baker 

grading is as follows: 

Grade I the breast is normally soft and looks natural 

Grade II the breast is a little firm but looks normal 

Grade III the breast is firm and looks abnormal 

Grade IV the breast is hard, painful, and looks abnormal.

Capsular contracture may be more common following infection, hematoma, and seroma. 

However, it is not known for sure why capsular contracture happens. The literature also 

discusses other factors, such as a textured implant surface and submuscular placement of 

the implant, which may decrease the capsular contracture rate. 

A reoperation may be needed to correct capsular contracture, usually for grade III or IV 

capsular contracture. The surgical procedures range from removal of the implant capsule 

tissue with or without replacement of the implant itself. Capsular contracture may 

happen again after this reoperation. 

The IOM report26 stated that, for studies involving both silicone gel-filled and salinefilled breast implants, the capsular contracture rates were 36-81% for silicone-gel filled 

breast implants and 8-41% for saline-filled breast implants. 

 

28 

26 Safety of Silicone Breast Implants. Institute of Medicine National Academy Press, Washington, D.C. 2000. {IOM 

Report}. Also available through IOM website at www.iom.edu.
Prospective studies of saline-filled breast implants approved by FDA in May 2000 

showed rates of grade III or IV capsular contracture of 9% at 3 years and 10-11% at 5 

years for augmentation patients. The same studies showed rates of grade III or IV 

capsular contracture of 25-30% at 3 years and 29-36% at 5 years for reconstruction 

patients.27,28 

Photograph 3 below shows grade IV capsular contracture in the right breast of a 29-yearold woman seven years after subglandular placement of 560cc silicone gel-filled breast 

implants.29 

Photograph 3: Capsular contracture in augmentation patient. 

Breast Pain 

Women may feel pain of varying degrees and length of time following breast implant 

surgery. In addition, improper size, placement, surgical technique, or capsular 

contracture may result in pain. You should tell your doctor if you have pain. 

The IOM report30 stated that pain is one of the primary reasons for implant removal and 

replacement even though few studies included in the medical literature report information 

about pain. 

 

27 Inamed patient labeling at FDA’s website at http://www.fda.gov/cdrh/breastimplants/. 28 Mentor patient labeling at FDA’s website at http://www.fda.gov/cdrh/breastimplants/. 29 Photograph courtesy of Walter Peters, Ph.D., M.D., F.R.C.S.C., University of Toronto. 

29 

30 Safety of Silicone Breast Implants. Institute of Medicine National Academy Press, Washington, D.C. 2000. {IOM 

Report}. Also available through IOM website at www.iom.edu.
Prospective studies of saline-filled breast implants approved by FDA in May 2000 

showed breast pain rates of 5-16% at 3 years and 7-17% at 5 years for augmentation 

patients. The same studies showed breast pain rates of 15-17% at 3 years and 16-18% at 

5 years for reconstruction patients.31,32 

Nipple and Breast Sensation Changes 

Sensation (feeling) in the nipple and breast can increase or decrease after implant surgery. 

The range of changes varies from intense sensation to no sensation in the nipple or breast 

following surgery. Changes in sensation can be temporary or permanent and may affect 

sexual response or the ability to nurse a baby. (Refer to the Specific Issues to Consider

section for more information on breast feeding.) 

Prospective studies33,34 of saline-filled breast implants approved by FDA in May 2000 

showed the following changes with regard to nipple and breast sensation for 

augmentation: 

• intense nipple sensation in 5-9% of women at 3 years and in 10% of women at 5 

years 

• loss of nipple sensation in 8-10% of women at 3 years and in 10% of women at 5 

years 

• intense skin sensation in 7% of women at 3 years and in 8% of women at 5 years. 

 

31 Inamed patient labeling at FDA’s website at http://www.fda.gov/cdrh/breastimplants/. 32 Mentor patient labeling at FDA’s website at http://www.fda.gov/cdrh/breastimplants/. 33 Inamed patient labeling at FDA’s website at http://www.fda.gov/cdrh/breastimplants/. 

30 

34 Mentor patient labeling at FDA’s website at http://www.fda.gov/cdrh/breastimplants/. 
The same prospective studies35,36 of saline-filled breast implants approved by FDA in 

May 2000 showed the following changes with regard to nipple and breast sensation for 

reconstruction: 

• loss of nipple sensation in 12-35% of women at 3 years and in 18% of women at 5 

years 

• intense skin sensation in 6% of women at 3 years and in 6% of women at 5 years. 

 

35 Inamed patient labeling at FDA’s website at http://www.fda.gov/cdrh/breastimplants/. 

31 

36 Mentor patient labeling at FDA’s website at http://www.fda.gov/cdrh/breastimplants/. 
DISEASES

Some women with breast implants have reported health problems that they believe are 

related to their implants, but most studies of these diseases have failed to show an 

association with breast implants. There also have been concerns about possible, but 

unproven, effects on health. Most of the health concerns about breast implants are related 

to the body reacting to a foreign material, such as silicone gel. These diseases are 

discussed below. 

Connective Tissue Diseases (CTDs) and Related Disorders 

These are a group of diseases and disorders related to the immune system and to the 

connective tissue of the body (e.g., muscle, tendon, bone, etc.) that supports body 

structures and binds body parts together. The body’s immune system is the network of 

cells that protect against infectious diseases. Antibodies are one type of substance the 

body produces to fight off infectious agents. 

The cause of CTDs is unknown. Some CTDs have autoimmune characteristics in that a 

woman’s immune system attacks her own cells as if they were foreign. 

CTDs with autoimmune characteristics include:

• lupus 

• rheumatoid arthritis 

• polymyositis 

• dermatomyositis 

• progressive systemic sclerosis or scleroderma. 

CTDs without autoimmune characteristics include: 

• fibromyalgia 

• chronic fatigue syndrome. 

32 
Some women with breast implants have experienced the diseases or disorders listed 

above, as well as a variety of signs and symptoms that could be related to the immune 

system or to the connective tissues of the body. However, these signs and symptoms are 

not considered a defined disease or disorder. These signs and 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 

• muscle weakness or burning. 

Signs and symptoms, such as those bulleted above, may be present in women 

without CTD or related disorders or in women without breast implants. Individual 

cases alone cannot scientifically prove or disprove a connection between CTDs and 

related disorders and breast implants. 

Some doctors and women have thought that these signs and symptoms are part of a new 

disease which is related to silicone and have called the disease "human adjuvant disease," 

“silicone related syndrome,” “atypical disease,” or other names. The IOM report37 stated 

“The diagnosis of this condition could depend on the presence of a number of symptoms 

that are nonspecific and common in the general population. Thus, there does not appear 

to be even suggestive evidence of a novel [new] syndrome in women with breast 

implants.” So, it is unclear at this time whether or not the signs and symptoms

 

33 

37 Safety of Silicone Breast Implants. Institute of Medicine National Academy Press, Washington, D.C. 2000. {IOM 

Report}. Also available through IOM website at www.iom.edu.
experienced by these women are related to their implants. In some cases, women have 

reported fewer symptoms after the implants were removed. In other cases, there was no 

change in signs and symptoms after the implants were removed. 

Studies have shown that some women with silicone gel-filled breast implants produced 

antibodies to their own collagen (a connective tissue protein), but we do not know how 

often these antibodies occur in the general population, and there are no data that show 

these antibodies cause CTDs and related disorders.38,39,40 There are reports of women 

with implants who have a variety of autoantibodies. (Autoantibodies are antibodies that 

your body makes that accidentally target your own tissues.) However, the presence of 

these autoantibodies does not mean that a woman has an increased risk of actually 

developing a CTD or related disorder. 

When considered together, these studies indicate that the risk of developing a typical or 

defined CTD or related disorder due to having a breast implant is low. However, these 

studies have not been large enough to resolve the question of whether or not breast 

implants slightly increase the risk of CTDs or related disorders. Researchers must study 

a large group of women without breast implants who are of similar age, health, and social 

status and who are followed for a long time (such as 10-20 years) before a relationship 

between breast implants and these diseases can conclusively be made. 

 

38Wolf LE, Lappe M, Peterson RD, et al. Human immune response to polydimethylsiloxane (silicone): screening 

studies in a breast implant population. FASEB J 1994;7:1265-1268. 39 Tueber SE, Rowley MJ, et al. Anti-collagen antibodies are found in women with silicone breast implants. J 

Autoimmunity 1993;6:357-377. 

34 

40 Rowley MJ Cook AD, et al. Antibodies to collagen: comparative epitope mapping in women with silicone breast 

implants, system lupus erythematosus and rheumatoid arthritis. J Autoimmunity 1994; 7:775-789.
There have been reports of women with fibromyalgia following breast implants, and a 

preliminary study conducted by FDA41 found an association between self-reported 

fibromyalgia and extracapsular rupture diagnosed by MRI. However, this association has 

not been repeated in a similar study based on a large group of Danish women

42 and the 

weight of the epidemiological evidence published in the literature does not support an 

association between fibromyalgia and breast implants. 

Cancers 

The IOM report43 indicates that breast cancer is no more common in women with breast 

implants than those without breast implants. While not conclusive, cancer rates have 

been reported to be slightly higher for some types of cancers. Cancers rates that have 

been higher in more than one study are lung and vulva. Because these cancers may be 

related to other factors that were not examined in these studies (such as smoking) these 

studies are not conclusive. 

More information on cancer and breast implants is available at the National Cancer 

Institute website at: 

• http://www.nci.nih.gov/newscenter/silicone-othercancers

• http://www.nci.nih.gov/newscenter/silicone-mortality

• http://www.nci.nih.gov/newscenter/siliconebreast. 

 

41 Brown, et al. Assn of SBI rupture and BI. Clin Rheumatol. 2002; 4(4);293-298. 42 Holmich, et al. Self-reported diseases and symptoms by rupture status among unselected Danish women with 

cosmetic silicone breast implants. Plast Recon Surg. 2003; 111(2):723-732. 

35 

43 Safety of Silicone Breast Implants. Institute of Medicine National Academy Press, Washington, D.C. 2000. {IOM 

Report}. Also available through IOM website at www.iom.edu.
Neurological Symptoms/Diseases 

Some women with breast implants have reported that they have neurological symptoms

(such as difficulties with vision, sensation, muscle strength, walking, balance, thinking or 

remembering things) or diseases (such as multiple sclerosis) related to their implants. 

Several studies have indicated that women with implants are not at an increased risk of 

being hospitalized with neurological disease compared to other women. The IOM 

report44 found no basis for thinking that women with implants were more likely to have 

neurological diseases or symptoms. 

Since the IOM report, Winther, et al.45 published additional follow-up of the Danish 

group of 1,653 women with cosmetic breast implant surgery at private clinics in Denmark 

compared to a comparison group of 1,736 women who underwent other types of cosmetic 

procedures. No increased risks for neurological disorders were found in the breast 

implant patients. However, it should be noted that these studies are limited in that rare 

disorders cannot be addressed. 

 

44 Safety of Silicone Breast Implants. Institute of Medicine National Academy Press, Washington, D.C. 2000. {IOM 

Report}. Also available through IOM website at www.iom.edu.

36 

45 Winther, JF, et al. Neurological disease among women with silicone breast implants in Denmark. Acta Neurol

Scand 2001; 103:93-96.
SPECIFIC ISSUES TO CONSIDER

Mammography 

Women with breast implants who are in an age group where routine mammograms are 

recommended should be sure to have these examinations at the recommended regularly 

scheduled times. Some women who undergo reconstruction will have some breast tissue 

remaining, and some have all of their breast tissue removed. It is important that a woman 

with remaining breast tissue continue to have mammography of that breast, as well as of 

the other breast, to detect breast cancer. (Those who have had breast cancer surgery on 

both breasts should ask their doctors whether mammograms are still necessary.) 

Women should be aware that breast implants may interfere with the detection of cancer 

and that breast compression (hard pressure) during mammography may cause implant 

rupture/deflation. 

Interference with mammography by breast implants may delay or hinder the early 

detection of breast cancer either by hiding suspicious lesions (wounds or injuries or 

tumors) or by making it more difficult to include them in the image (x-ray, ultrasound). 

Implants increase the difficulty of both taking and reading mammograms. 

Mammography requires breast compression, which could contribute to implant rupture. 

According to the FDA adverse event database, there were 41 reported cases of breast 

implant rupture during mammography reported between 1992 and 2002.46 An additional 

17 cases of rupture during mammography were reported in the medical literature. 

 

37 

46 Brown SL, Ferlo Todd J, Luu H-MD. Breast implant adverse events during mammography: reports to the Food

and Drug Administration. Journal of Women’s Health 2004; 13:1-8. A summary of the findings of this study is also 

available on FDA’s website at http://www.fda.gov/cdrh/breastimplants/. 
In addition to special care taken by the radiological technologist to reduce the risk of 

implant rupture during this compression, other techniques are used to maximize what is 

seen of the breast tissue during mammography. These techniques are called breast 

implant displacement views, Eklund displacement views, or Eklund views, named for the 

radiologist who developed the techniques. These special implant displacement views are 

done in addition to those views done during routine mammograms. 

Because of the extra views and time needed, women with implants should always inform 

the receptionist or scheduler that they have breast implants when making an appointment 

for mammography. They should also tell the radiological technologist about the presence 

of implants before mammography is performed. Then, the radiological technologist will 

use these special displacement techniques and take extra care when compressing the 

breasts to avoid rupturing the implant. 

The displacement procedure involves pushing the implant back and pulling the breast 

tissue into view. Several factors that may affect the success of this special technique in 

imaging the breast tissue in women with breast implants include the location of the 

implant, the hardness of the capsular contracture, and the amount of the breast tissue 

compared to the implant size. 

Also, when reading the mammogram, the radiologist may find it difficult to distinguish 

calcium deposits in the scar tissue around the implant from a breast tumor. Occasionally, 

it is necessary to remove and examine a small amount of tissue (biopsy) to see whether or 

not it is cancerous. Frequently, this can be done without removing the implant. 

As a last note, FDA does not consider mammograms an adequate means of detecting 

implant rupture/deflation for silicone gel-filled breast implants. As described in the 

Local Complications & Reoperations (Rupture/Deflation of Silicone Gel-Filled

Breast Implants) section above, FDA believes that MRI is currently the best method for 

detecting implant rupture for silicone gel-filled breast implants. 

38 
Breast Feeding

Women of childbearing age should know that they may not be able to breast feed after 

breast implantation. Some women who undergo breast augmentation can successfully 

breast feed and some cannot. Women who undergo a mastectomy will be unable to 

breast feed on the affected side due to loss of breast tissue and glands that produce milk. 

The IOM report47 said that women with either silicone gel-filled or saline-filled breast 

implants showed lactation insufficiency (not enough milk) ranging from 28-64%. The 

periareolar approach (incision cite is around the nipple) was the factor most associated 

with lactation insufficiency. 

Having a breast implant may also influence a woman’s decision about whether or not she 

will try to breast feed, particularly if she has capsular contracture or is worried about 

problems with the implants.48

Effects on Children

There are two concerns associated with the effects on children: 

• the safety of the milk from mothers with breast implants for breast feeding children 

• the effects of silicones and other chemicals on children born of mothers with breast 

implants (second-generation effects). 

It is not known if a small amount of silicone may pass from the silicone shell of an 

implant into breast milk. If this occurs, it is not known what effect it may have on the 

nursing infant. There are no current methods for detecting silicone levels in breast milk. 

 

47 Safety of Silicone Breast Implants. Institute of Medicine National Academy Press, Washington, D.C. 2000. {IOM 

Report}. Also available through IOM website at www.iom.edu.

39 

48 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;100:1553-1557. 
The IOM report49 said that there is convincing evidence that infants breast-fed by 

mothers with breast implants receive no higher silicon intakes from breast milk than 

infants breast-fed by mothers without breast implants. (Silicon is an element that is one 

component of the polymer silicone and is one of the most abundant elements on the earth. 

Everyone is exposed to silicon.) 

Concerns have been also raised about the potential damaging effects on children born of 

mothers with implants. The IOM report50 said that the information is insufficient or 

flawed to draw definite conclusions about this issue. In other words, it is not known what 

effect breast implants may have on an unborn baby (fetus) and the nursing infant. 

Several studies since the IOM report have suggested that the risk of birth defects overall 

is not increased in children born after implant surgery.51,52 These studies are comforting, 

but, because they are small and of short duration, they cannot rule out a very small risk. 

Suicide 

Several recent studies have found a slight increase in deaths due to suicide among women 

with cosmetic breast implants.53,54,55 The reason for this increase is unknown although 

some suggest that this may be due to underlying psychological problems in women who 

 

49 Safety of Silicone Breast Implants. Institute of Medicine National Academy Press, Washington, D.C. 2000. {IOM 

Report}. Also available through IOM website at www.iom.edu. 50 Safety of Silicone Breast Implants. Institute of Medicine National Academy Press, Washington, D.C. 2000. {IOM 

Report}. Also available through IOM website at www.iom.edu. 51 Kjoller K, Friis S, Signorello LB McLaughlin JK, Blot WJ, Lipworth L, Mellemkjaer L, Winther J, Olsen J. 

Health outcomes in offspring of Danish mothers with cosmetic breast implants. Ann Plast Surg 48;238-245, 2002. 52 Signorello LB, Fryzek JP, Blot WJ, McLaughlin JK, Nyren O. Offspring health risk after cosmetic breast 

implantation in Sweden. Ann Plast Surg 46:279-286, 2001. 53 Brinton LA, Lubin JH, Burich MC, Colton T, Hoover RN. Mortality among augmentation mammoplasty patients. 

Epidemiology 2001;12:321-326. 54 Koot VCM, Peeters PHM, Granath F, Grobbee DE, Nyren O. Total and cause specific mortality among Swedish

women with cosmetic breast implants: prospective study. BMJ 326;527-528. 

40 

55 Pukkala E, Kulmala I, Hovi S-L, Hemminki E, Keskimäki I, Lipworth L, Boice JD, McLaughlin JK. Causes of 

death among Finnish women with cosmetic breast implants, 1971-2001. Ann Plast Surg 2003;51:339-342. 
get breast implants for cosmetic reasons.56,57 Others have suggested that women may be 

distressed because of the burden of breast implant complications.58

Gel Bleed

A concern related specifically to silicone-gel filled breast implants is that small amounts 

of the silicone fluid or oil may bleed through the shell and travel into the surrounding 

tissue. This escaped silicone fluid or oil might cause local complications. There is 

inadequate information to determine whether or not gel bleed is a problem because there 

have been no studies that measure the amount of gel bleed and relate it to local 

complications. 

Platinum 

Platinum is a metal used in the manufacture of some breast implants. Recent scientific 

literature indicates that the platinum leaches (leaks) from these implants and is present in 

the surrounding tissue.59 Because certain chemical forms of platinum can cause allergic 

reactions, there has been concern that platinum that leaches from the implants may be 

harmful. FDA scientists reviewed the currently available studies from the medical 

literature on platinum and breast implants and did not find evidence that leached platinum 

causes illness in women with breast implants.60

 

56 Pukkala E, Kulmala I, Hovi S-L, Hemminki E, Keskimäki I, Lipworth L, Boice JD, McLaughlin JK. Causes of 

death among Finnish women with cosmetic breast implants, 1971-2001. Ann Plast Surg 2003;51:339-342. 57 Joiner TE. Does breast augmentation confer risk of or protection from suicide. Aesthetic Surgery Journal, 2003. 58 Zuckerman D. Mortality in Swedish women with cosmetic breast implants. BMJ 2003;326:1266. 59 Flassbeck D, Pfleiderer B, Klemens P, Heumann KG, Eltze E, and Hirner AV. Determination of siloxanes, 

silicone, and platinum in tissues of women with silicone gel-filled implants."Anal Bioanal Chem (2003) 375: 356-

362. 

41 

60 Arepelli S, Bezebah S, Brown SL, Allergic reactions to platinum in silicone breast implants. J Long-Term Effects 

Medical Implants 2002; 299-306. 
Silicone Sensitivity 

Currently, there are no FDA-approved tests to detect silicone in the body or to determine 

whether or not a woman's immune system is sensitive to any component of silicone 

breast implants. 

Determining that silicon or silicone is present in body fluids does not indicate whether a 

person is sensitive to these substances or at risk for any specific disease. (Silicon is an 

element that is one component of the polymer silicone and is one of the most abundant 

elements on the earth. Everyone is exposed to silicon.) Some researchers claim to have a 

test that can detect antibodies to silicone in blood; however, the proven accuracy and 

usefulness of the test has not been determined. Some researchers have also claimed that a 

test called the Anti-Polymer Antibody Assay (APA) is able to distinguish signs and 

symptoms of disease ranging from mild to severe in women with implants. However, a 

recent report61 failed to find an increased level of APA activity in women who had 

silicone breast implants and health complaints compared with healthy women without 

implants. The accuracy of this test, the clinical usefulness of the test results, and the 

biological basis for the assay has not been established. 

Even if antibodies to silicone were detected, the importance would be unclear. 

Antibodies to silicone would not necessarily mean that silicone is harmful or that a 

person would necessarily have an adverse reaction to it. Some researchers have also 

reportedly developed a test to detect if a woman's immune system is sensitive to silica, a 

component found in silicone breast implants. The accuracy of this test also has been 

questioned, and it is not clear at this time whether the results of this test have clinical 

usefulness. 

 

42 

61 De Jong, WH, Kallewaard, M, Goldhoorn, CA, Verhoef, CM, Bijlsma, WJ, Schouten, JSAG, and Van Loveren, 

H. Long-term exposure to silicone breast implants does not induce antipolymer antibodies; Biomaterials 25 (2004)

1095-1103. 
Recent published results62 indicate that silicon and certain silicones found in breast 

implants are present in tissues surrounding these implants. However, the results do not 

provide evidence that either silicon or the detected silicones are responsible for adverse 

immunological (or other toxic) reactions to breast implants. One or more of the silicones 

found in these studies are also found in food and many other products, including 

commonly used medicines and cosmetics. Therefore, exposure to these silicones from 

other sources is widespread. Although there is continued interest in potential adverse 

reactions to silicones, the current scientific information does not provide convincing 

evidence of adverse immunological effects.

Polyurethane Foam-Coated Breast Implants 

This section is applicable to those women who received a polyurethane foam-coated 

breast implant. 

Until the polyurethane foam-coated breast implants were taken off the market in 1991 

because of concerns that the coating might increase the risk of breast cancer, about 10% 

of women with breast implants received the polyurethane foam-coated type of breast 

implant. The polyurethane foam coating released small quantities of the chemical called 

TDA (2,4-toluenediamine) that has been shown to cause cancer in animals. 

Because of this concern, the manufacturer of the polyurethane foam-coated implants, 

Bristol-Myers Squibb Company, analyzed the urine of women with these devices for 

TDA.63 Researchers found TDA in the urine but in such tiny amounts that the risk of 

 

62 Flassbeck, D, Pfleiderer, B, Klemens, P, Heumann, KG, Eltze, E, and Hirner, AV. Determination of siloxanes, 

silicone, and platinum in tissues of women with silicone gel-filled implants; Anal Bioanal Chem 375 (2003) 356-

362.

43 

63 Hester TR Jr, Ford NF, Gale PJ, Hammett JL, Raymond RH, Turnbull D, Frankos VH, Cohen MB. Measurement

of 2,4,toluenediamine in the urine and serum samples from women with Meme or Replicon breast implants. Plast 

Reconstr Surg, 1997;100:1291-1298. 
cancer from the polyurethane foam-coated implants is only about one in a million over a 

woman’s lifetime. Therefore, it is unlikely that even one of the estimated 110,000 

women who got the polyurethane foam-covered implants will get cancer as a result of 

exposure to the TDA. This study supports FDA’s recommendation that women with 

polyurethane foam-covered breast implants should not have them removed based solely 

on concerns about cancer from TDA. 

Concerns have also been raised about whether the TDA from the polyurethane foamcoated implants could increase the risk of cancer to a nursing infant. FDA required the 

company to analyze mother's milk for TDA, but the company was unable to get enough 

lactating women with these implants to conduct a valid study. 

Trilucent Breast Implants 

This section is applicable to those women who received TrilucentTM breast implants. 

The TrilucentTM is an alternate breast implant that consists of a silicone shell filled with 

purified soybean oil. Although the TrilucentTM breast implants were once part of an IDE 

study, which is now closed, the TrilucentTM breast implants were never approved for 

marketing in the U.S. They were, however, approved for marketing in Europe. The 

Medical Device Agency (MDA), the British equivalent of the FDA, removed TrilucentTM 

breast implants from the market in the United Kingdom in March 1999 as a result of their 

investigation of reported adverse events. Their concern was that breakdown products of 

the soybean oil filler in TrilucentTM breast implants could cause cancer. 

In June 2000, the MDA issued a hazard notice recommending women to consider having 

their TrilucentTM breast implants removed and to avoid pregnancy and breast-feeding 

while they still are implanted with their TrilucentTM breast implants. The MDA hazard 

notice is available on MDA’s website at http://www.medical-devices.gov.uk. 

44 
A recently published study of explanted TrilucentTM breast implants indicated that all 

explanted implants showed evidence of shell deterioration, probably because the lipid in 

the TrilucentTM filler interacts with and weakens the shell.64 This may contribute to 

rupture of these implants. Also, high levels of the breakdown products were found in all 

TrilucentTM breast implants tested. 

Additional information from Inamed Corporation is available at 

http://www.inamed.com/con_info/us/con_information.html. 

 

45 

64 Kirkpatrick WNA, Jones BM. The history of Trilucent implants, and a chemical analysis of the triglyceride filler 

in 51 consecutively removed Trilucent breast prostheses. Brit J Plast Surg 2002;55:479-489. 
BREAST IMPLANT SURGERY & RELATED ISSUES

Choosing a Surgeon 

When choosing a surgeon who is experienced with breast implantation, we recommend 

that you find out the answers to the following questions: 

 

In which states is he/she licensed to practice surgery? Note that some state 

medical licencing boards provide information on disciplinary action and 

malpractice claims/settlements to prospective patients either by request or on the 

internet. 

•

•

•

•

•

•

Is he/she board certified, and if so, with which board? 

How many breast augmentation, reconstruction, or revision surgeries does 

he/she perform per year? 

How many years has he/she performed breast implantation surgeries? 

What are the most common complications he/she encounters with patients after 

breast implantation? 

What is his/her reoperation rate with breast implants and what is the most 

common type of reoperation he/she performs? 

When you have answers to these questions, you will have a better idea of the technical 

qualifications of your surgeon. 

46 
Choosing an Implant 

You should consider the following when you and your surgeon are discussing implant 

options. 

Implant Status – Whether or not an implant is PMA-approved or investigational (not 

PMA-approved) should be something you consider (see the Status/Availability section 

for details). An implant that is investigational means you will need to be part of a clinical 

study to get these implants. In addition, the surgeon of your choice may work with only 

specific breast implants. 

Shape and Size - Depending on the desired shape and size you wish to achieve, you and 

your surgeon may choose a round or contoured implant shape of appropriate size 

(volume). You should be aware that contoured implants that are placed submuscular 

(under the pectoralis major muscle) may assume a round shape after implantation. Your 

surgeon will also evaluate your existing tissue to determine if you have enough to cover 

the breast implant. 

Implant Surface - Textured surface implants were designed to reduce the chance of 

capsular contracture. Some studies with small numbers of women suggest that surface 

texturing reduces the chance of severe capsular contracture. However, other studies of a 

large number of women with saline-filled implants show no difference in the likelihood 

of developing capsular contracture with textured implants when compared to smoothsurfaced implants. 

Implant Palpability/Visibility - The following may cause implants to be more palpable 

(more easily felt) or more visible: textured implants; larger implants; subglandular 

placement; and smaller amount of skin/tissue available to cover the implant. 

47 
Choosing the Surgical Incision Site 

You should discuss the pros and cons for each incision site you are considering with your 

surgeon. Your surgeon may recommend an incision site for you depending on whether 

you will be having augmentation or reconstruction. 

Augmentation Incision Sites – The three common incision sites are under the arm

(transaxillary), around the nipple (periareolar), or within the breast fold (inframammary). 

The sketch below shows each of these incisions sites.65 

• Transaxillary – This incision is less concealed than periareolar but associated with 

less difficulty than the periareolar incision site when breast feeding. 

• Periareolar – This incision is most concealed but is associated with a higher 

likelihood of inability to successfully breast feed, as compared to the other 

incision sites. 

• Inframammary – This incision is less concealed than periareolar but associated 

with less difficulty with breast feeding than the periareolar incision site. 

 

Under arm

(transaxillary) 

incision 

Around nipple 

(periareolar) 

In breast fold 

(inframammary) incision 

The umbilical/endoscopic incision site is not recommended by companies.

48 

 

65 Sketch from Inamed patient labeling at FDA’s website at http://www.fda.gov/cdrh/breastimplants/. 
Reconstruction Incision Sites - Most implants in breast reconstruction use the

mastectomy scar either immediately during the mastectomy procedure or after tissue 

expansion. 

Choosing the Type of Implant Placement

The breast implant can be placed either submuscularly or subglandularly. You should 

discuss with your surgeon the pros and cons of the implant placement selected for you. 

Submuscular Placement 

Possible Results 

Subglandular Placement 

Possible Results 

Surgery may be longer Surgery may be shorter 

Recovery may be longer Recovery may be shorter 

Reoperation may be more difficult May provide easier access for reoperation 

Less palpable implants More palpable implants 

Easier imaging during mammography 

exam 

More difficult imaging during 

mammography exam 

The sketches below show the differences between subglandular and submuscular 

placement of your implant compared to a breast before augmentation.66

 

Breast before augmentation Breast after Breast after 

subglandular augmentation submuscular augmentation 

 

49 

66 Sketches from Inamed patient labeling at FDA’s website at http://www.fda.gov/cdrh/breastimplants/. 
General Description of Breast Implant Surgery 

Breast implant surgery can be performed on an outpatient (not in the hospital) basis or in 

a hospital. It can be done under local anesthesia (only the breast area is numbed) or 

under general anesthesia (put to sleep or not aware of having surgery). 

Breast implant surgery can last from one to several hours depending on your particular 

case (your condition, implant choice, incision site, implant placement, etc.). 

If the surgery is done in a hospital, the length of the hospital stay will vary according to 

the type of surgery, the development of any postoperative (after surgery) complications, 

and your general health. The length of the hospital stay may also depend on the type of 

coverage your insurance provides. 

Before surgery, your doctor should discuss with you the extent of surgery, the estimated 

time it will take, and the choice of treatment for pain and nausea. 

50 
After the Surgery 

Your doctor should describe the usual postoperative recovery process, the possible 

complications that can arise, and the expected recovery period. Following the operation, 

as with any surgery, you can expect some pain, swelling, bruising, and tenderness. These 

complications may last for a month or longer, but they should disappear with time. In 

addition, scarring is a natural outcome of surgery. Ask your doctor to describe the 

location, size, and appearance of the scars you can expect to have. For most women, 

scars will fade over time to thin lines, although the darker your skin, the more prominent 

the scars are likely to be. 

Your doctor may prescribe medications for pain and nausea. Some women may 

experience bleeding and some may experience fever, warmth, or redness of the breast, or 

other symptoms of infection. You should report these symptoms immediately to your 

doctor. Your doctor should tell you about wound healing and how to care for your 

wound. Drains may be used for a few days. 

You may need a post-operative bra, compression bandage, or jog bra for extra support 

and positioning while you heal. At your doctor’s recommendation, you will most likely 

be able to return to work within a few days, although you should avoid any strenuous 

activities that could raise your pulse and blood pressure for at least a couple of weeks. 

Your doctor may also recommend breast massage exercises. 

Ask your doctor about a schedule of follow-up examinations, limits on your activities, 

precautions you should take, and when you can return to your normal routine, including 

exercising. (If you are enrolled in a clinical study, your doctor should give you a 

schedule for follow-up examinations set by the study plan.) 

51 
Choices in Reconstructive Procedures 

The type of breast reconstruction procedures available to you depends on your medical 

situation, breast shape and size, general health, lifestyle, and goals. You can have your 

breast reconstructed with a breast implant, a tissue flap (your own tissues), or a 

combination of the two. If you have breast reconstruction, with or without breast 

implants, you will probably undergo several reoperations to improve symmetry and 

appearance. 

For example, after your breast has healed from the original implant surgery, you may 

want to build a new nipple and darken the areola (skin around the nipple). This 

procedure can usually be performed on an outpatient basis. Ask your doctor to explain 

the various ways this can be done, such as using a skin graft from the opposite breast or 

by tattooing the area. Ask your doctor about the pros and cons of each implant technique. 

If you decide to have reconstruction for one breast, your doctor may suggest surgery on 

the other breast to achieve a similar appearance. 

The following issues should be considered for women with breast cancer: 

• The physical and cosmetic results with breast implants may be affected by 

chemotherapy, radiation therapy, or any other factor that significantly affects the 

healing process. 

• Skin necrosis may occur because blood circulation to the remaining tissue has 

been changed by a mastectomy. Radiation treatment may also increase skin 

necrosis. 

• It usually takes more than one operation to achieve the desired cosmetic outcome, 

especially if the reconstruction procedures include building a new nipple. 

• Breast reconstruction is an optional procedure and is not needed to treat the 

cancer. 

52 
Breast Reconstruction with Breast Implants 

The following information applies to reconstruction following mastectomy. However, 

similar considerations apply to reconstruction for breast trauma or congenital defects. 

Your doctor will decide whether your health and medical condition makes you an 

appropriate candidate for breast reconstruction with breast implants. Women with larger 

breasts may require reconstruction with a combination of a tissue flap and an implant. 

Your doctor may recommend a breast implant, reduction mammoplasty (breast 

reduction), or a mastopexy (breast lift), of your opposite, uninvolved breast to improve 

symmetry with your reconstructed breast. Reduction mammoplasty involves removal of 

breast tissue and skin. Mastopexy involves removing a strip of skin from under the breast 

or around the nipple and using it to lift and tighten the skin over the breast. If it is 

important to you not to alter the unaffected breast, you should discuss this with your 

doctor because it may affect the breast reconstruction procedures considered for your 

case.

The breast reconstruction process may begin at the time of your mastectomy (immediate 

reconstruction) or weeks to years afterwards (delayed reconstruction). 

Immediate reconstruction is one-stage or two-stage reconstruction. 

• One-stage breast reconstruction may be done at the time of your mastectomy. 

After the general surgeon removes your breast tissue, the plastic surgeon will 

insert a breast implant under the skin where breast tissue was removed.

• Two-stage reconstruction is more typical. The first stage is a breast tissue 

expander placed, at the time of your mastectomy, to stretch your skin and create a 

pocket for a breast implant. Tissue expansion typically lasts four to six months. 

The tissue expander is then replaced several months later with a breast implant. 

53 
This is considered immediate reconstruction because the tissue expander is placed 

at the time of mastectomy.

Delayed reconstruction is a two-stage reconstruction starting with a breast tissue 

expander placed months or years later, which is then replaced several months later with a 

breast implant. This is considered delayed reconstruction because the tissue expander is 

placed after the mastectomy site has healed. 

It is important to know that the one and two-stage references do not mean the 

number of surgeries involved. You should expect that any type of breast 

reconstruction will take several steps to complete. It could take months to years 

before your reconstruction is complete. 

Two potential advantages to immediate reconstruction are that your breast reconstruction 

starts at the time of your mastectomy and that you may save money when you combine 

the mastectomy with the first stage of the reconstruction. However, with immediate 

reconstruction, there may be a higher risk of complications, such as rupture/deflation, as 

well as longer initial operation and healing times. 

A potential advantage to delayed reconstruction is that you can delay your reconstruction 

decision and surgery until other treatments, such as radiation therapy and chemotherapy, 

are completed. Delayed reconstruction may be advisable if your surgeon anticipates 

healing problems with your mastectomy, or if you just need more time to consider your 

options. 

There are medical, financial, and emotional considerations to choosing immediate versus 

delayed reconstruction. You should discuss the pros and cons with the options available 

in your individual case with your surgeon, plastic surgeon, and oncologist. 

54 
Breast Reconstruction with Tissue Flaps 

The breast can be reconstructed by surgically moving a section of skin, fat, muscle, and 

blood vessels from one area of your body to another. The tissue may be taken from such 

areas as your lower abdominal area, upper back, or buttocks. 

The most common types of tissue flaps are: 

• the TRAM (transverse rectus abdominus musculocutaneous) flap that uses tissue 

from the lower abdominal area 

• the Latissimus Dorsi flap that uses tissue from the upper back. 

Flap surgery has the advantage of using your own tissue to construct a new breast. 

However, it is important for you to be aware that flap surgery, particularly TRAM flap 

surgery, is a major operation and more extensive than your mastectomy operation or 

breast implant surgery. It requires good general health and strong emotional motivation. 

If you are very overweight, smoke cigarettes, have had previous surgery at the flap site, 

or have any circulatory problems, you may not be a good candidate for a tissue flap 

procedure. Also, if you are very thin, you may not have enough tissue at the flap site to 

construct a breast mound. 

Tissue flaps, in general, can be moved to the reconstruction site by one of two methods. 

The first method is when the flap is left attached to the muscle and blood vessels and 

tunneled under the skin to the reconstruction site. The second method is when the flap is 

completely removed and then transferred to the reconstruction site and reattached by 

microsurgery. More specifically, the TRAM flap can be done by either of these two 

methods while the Latissimus Dorsi flap procedure involves only the first method. In 

addition, for TRAM flap surgery, your surgeon may also need to build you a new belly 

button after the lower abdominal area is reshaped. 

55 
Flap surgery requires a hospital stay of several days and generally a longer recovery time 

than breast implant reconstruction. While you can resume normal daily activity after 

several weeks, some women report that it takes up to one year to resume a normal 

lifestyle. 

Flap surgery also creates scars at the site where the flap was taken and possibly additional 

scars on the reconstructed breast. You may also have some temporary or permanent 

decreased muscle strength at the flap site. 

As a special note regarding the TRAM flap procedure, if you are considering pregnancy 

after your reconstruction, you should discuss with your surgeon how this procedure may 

affect your abdominal muscle strength. In addition, although abdominal tissue feels like 

breast tissue to the touch, the nerves are cut during the surgery, so there may be little 

feeling or sensitivity in your breast. Also, you should know that a surgeon can take tissue 

from your abdomen only once. If you later need a mastectomy of your second breast and 

want to have a tissue flap procedure, then the tissue will have to come from another site, 

such as your back.

56 
Questions to Ask Your Surgeon about Breast Augmentation 

The following list of questions may help you to remind you of topics to discuss with your

surgeon. You may have additional questions as well. 

1. What are the risks and complications associated with having breast implants? 

2. How many additional operations of my implanted breast(s) can I expect over 

my lifetime? 

3. How will my breasts look if I choose to have the implants removed without 

replacement? 

4. What shape, size, surface texturing, incision site, and placement site is 

recommended for me? 

5. How will my ability to breast feed be affected? 

6. How can I expect my implanted breasts to look over time? 

7. How can I expect my implanted breasts to look after pregnancy? After 

breastfeeding? 

8. What are my options if I am dissatisfied with the cosmetic outcome of my 

implanted breasts? 

9. What alternate procedures or products are available if I choose not to have 

breast implants? 

10. Do you have before and after photos I can look at for each procedure and what 

results are reasonable for me? 

57 
Questions to Ask Your Surgeon about Breast Reconstruction 

The following list of questions may help to remind you of topics to discuss with your 

surgeon. You may have additional questions as well. 

1. What are all my options for breast reconstruction? 

2. What are the risks and complications of each type of breast reconstruction 

surgery and how common are they? 

3. What if my cancer recurs or occurs in the other breast? 

4. Will reconstruction interfere with my cancer treatment? 

5. How many steps are there in each procedure? What are they? How much 

experience do you have with each procedure? What is the estimated total cost 

of each procedure? 

6. How long will it take to complete my reconstruction? 

7. Do you have before and after photos I can look at for each procedure and what 

results are reasonable for me? 

8. What will my scars look like? 

9. What kind of changes in my implanted breast can I expect over time? 

10. What kind of changes in my implanted breast can I expect with pregnancy? 

11. What are my options if I am dissatisfied with the cosmetic outcome of my 

implanted breast? 

12. How much pain or discomfort will I feel and for how long? 

13. How long will I be in the hospital? Will I need blood transfusions, and can I 

donate my own blood? 

14. When will I be able to resume my normal activity (such as athletic activity, 

sexual activity)? 

58 
RESOURCE GROUPS

All resource group information, except for FDA’s 

Consumer Affairs Staff contact information, has 

been moved online to the “Breast Implant 

Resource Groups” webpage. 

Visit FDA’s breast implant website for this and 

other up-to-date information, available at: 

http://www.fda.gov/cdrh/breastimplants/. 

59 
THIS PAGE HAS BEEN INTENTIONALLY 

LEFT BLANK.

60 
FDA’s Consumer Affairs Staff 

The Consumer Affairs Staff is a consumer resource to answer breast implant calls and 

distribute the breast implant consumer handbook. To contact the Consumer Affairs Staff, 

use one of the following options: 

• Call: 301-827-3990 

This is a direct line to the Consumer Affairs Staff. 

• Call: 1-888-463-6332 

This toll free number involves a series of prompts that leads to the Consumer 

Affairs Staff. The messages at each level at this toll free number change 

frequently, so specific numbers are not given. However, we provide the 

following tips. The first prompt to listen for is to talk to someone regarding a 

regulated product. Afterwards, listen for the prompts regarding talking to 

someone or obtaining information regarding medical devices. This should 

lead you to the Consumer Affairs Staff. 

• Email: dsmica@cdrh.fda.gov

• Write to: Food and Drug Administration, Office of Health and Industry Programs, 

Consumer Affairs Staff, 1350 Piccard Drive, HFZ-210, Rockville, MD 20850.

• Website: www.fda.gov/cdrh/consumer.

61 
TIMELINE OF BREAST IMPLANT ACTIVITIES

• May 28, 1976: The Medical Device Amendments were enacted, giving FDA authority 

to regulate medical devices such as breast implants, which were already on the 

market. 

• July 23, 1976: The FDA General and Plastic Surgery Devices Panel (the Panel) 

recommended that breast implants be placed in class II, requiring general controls and 

performance standards. Under the law, there are three regulatory categories for 

medical devices. Class I devices are usually simple devices whose risks can be 

controlled by labeling and the manufacturing process. Class II devices require 

additional measures, called special controls, to control risks. Special controls may 

include performance standards, postmarket surveillance studies, user education, or 

other measures. If there is a lack of information about whether a device is safe and 

effective, it is put into class III, and the highest level of premarket review is required. 

Class III devices include innovative (creative), medical breakthrough, new technology 

devices, and devices with poorly established or questionable safety and effectiveness. 

• January 19, 1982: Because of some reports of adverse events in the medical literature, 

FDA announced a proposal to place breast implants in class III. Class III devices 

have strict controls for safety and effectiveness. 

• June 24, 1988: FDA classified all breast implants into class III. After a prescribed 

waiting period of 30 months, FDA could require the submission of PMAs in which 

manufacturers present data showing the safety and effectiveness of these devices. 

• January 6, 1989: FDA published a notice of intent to require submission of PMAs for 

saline-filled and silicone gel-filled breast implants. 

62 
• January - March 1989: An unpublished study showed that polyurethane foam, which 

was used as a coating on certain types of silicone gel-filled breast implants, would 

degrade and release 2-toluene diamine (TDA), a chemical known to cause cancer in 

animals, under conditions of high temperature and alkalinity (high pH). FDA 

requested specific information from the manufacturer about the chemical make up and 

safety testing of polyurethane foam. Shortly afterwards, the manufacturer of 

polyurethane foam-coated breast implants removed them from the market. 

• May 17, 1990: FDA issued a proposed 515(b) regulation (call for safety and 

effectiveness data) in the Federal Register on silicone gel-filled breast implants. 

• February 1-2, 1991: FDA sponsored a Conference on Silicone in Medical Devices. 

This was an exchange of scientific information and views on the applications of 

silicone in medical devices. 

• April 10, 1991: FDA published a final 515(b) regulation in the Federal Register that 

required manufacturers of silicone gel-filled breast implants to submit PMAs with 

data showing a reasonable assurance of safety and effectiveness of the implants by 

July 9, 1991. 

• June 1991: FDA required the company of polyurethane foam-coated breast implants 

to conduct research on the material. In taking this action, FDA made the first use of 

new postmarket surveillance authority under the Safe Medical Devices Act of 1990. 

• July 31, 1991: The Panel reviewed FDA's risk assessment of polyurethane foam

coating. The Panel found that the risk of cancer, if any, appears small and would very 

likely be outweighed by the surgical risk involved in removing a polyurethane-coated 

breast implant. 

63 
• August 22, 1991: FDA determined that PMAs submitted by three companies of 

silicone gel-filled breast implants did not contain sufficient data to warrant a full 

review. 

• September 26, 1991: FDA issued a Notice in the Federal Register requiring 

distribution of information to patients on the risks associated with saline-filled and 

silicone gel-filled breast implants. 

• November 12-14, 1991: FDA convened the Panel to consider whether the PMA data 

received from the companies was sufficient to establish that the silicone gel-filled 

breast implants are safe and effective. Despite the lack of data, the Panel voted 

unanimously (complete agreement) to advise FDA that the implants filled a public 

health need for breast reconstruction and revision for medical or surgical reasons and 

that the implants should continue to be available while the companies collected 

additional data. 

• January 6, 1992: FDA called for a voluntary moratorium (delay) on the use of silicone 

gel-filled breast implants until new safety information could be thoroughly reviewed 

by the Panel. 

• February 18, 1992: The Panel met again to review new information on silicone gelfilled implants. This included case reports of autoimmune diseases, information not 

included in the companies' original submissions to FDA, and evidence that some early 

models may have leaked excessively. 

• March 19, 1992: Dow Corning withdrew from the silicone implant market but 

continued to supply gel to one implant company. 

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• April 16, 1992: FDA lifted the voluntary moratorium on breast implants. FDA also 

announced its decision to allow access to silicone gel-filled breast implants only under 

controlled clinical studies for reconstruction after mastectomy, correction of 

congenital deformities, or replacement of ruptured silicone gel-filled implants due to 

medical or surgical reasons. Until the these clinical studies (adjunct studies) could be 

submitted and reviewed, FDA authorized temporary limited distribution of silicone 

gel-filled implants for reconstructive patients on an urgent need basis with a very 

detailed informed consent form. FDA denied applications for using silicone gel-filled 

breast implants for augmentation but planned that the companies would later conduct 

clinical trials that would include a limited number of augmentation patients (core or 

IDE studies). 

• July 24, 1992: FDA approved Mentor Corporation’s adjunct study protocol for 

silicone gel-filled breast implants for reconstruction and revision patients only. 

• December 1992: Dow Corning announced that it would no longer make five implant 

grades of silicone for sale after March 31, 1993, but that it would continue to 

manufacture 45 other medical grades of silicone materials. 

• January 8, 1993: FDA published a 515(b) proposal in the Federal Register calling for 

safety and effectiveness data for saline-filled breast implants. 

• June 2, 1994: FDA sponsored a Part 15 Hearing on saline-filled breast implants to 

hear testimony from all interested parties concerning the timing of the agency's review 

of the safety and effectiveness of saline-filled breast implants. FDA promised to 

make a decision by the end of the year. 

July 15, 1994: FDA granted conditional approval of an IDE pilot study of 50 patients 

for a breast implant filled with a purified form of soybean oil (TrilucentTM implant). 

•

65 
• October 21, 1994: FDA sponsored the workshop Alternatives to Silicone Breast 

Implants. The workshop provided a forum for FDA to present a draft guidance 

document for testing requirements for alternative breast implants. 

• December 23, 1994: FDA issued a Talk Paper describing the types of studies required 

to demonstrate the safety and effectiveness of saline-filled breast implants and the 

date the studies are expected to be completed. Preclinical data were submitted 

throughout 1995. Final clinical data were expected by early 1999. 

• April 20, 1995: FDA updated the patient information sheet (entitled “Information for 

Women Considering Saline-Filled Breast Implants”) on the risks of saline-filled 

breast implants that companies give to physicians who, in turn, provide them to 

patients considering implant surgery. 

• January 11, 1996: FDA sent a letter to companies of silicone gel-filled breast implants 

detailing the type of information needed for core studies (IDE studies) of the silicone 

gel-filled breast implants for augmentation, reconstruction, and revision patients. 

• September 4, 1996: Poly Implants Protheses (PIP)’s 510(k) for their saline-filled 

breast implants was cleared for marketing by FDA. 

• September 19, 1996: FDA received a Citizen's Petition from the Y-Me National 

Breast Cancer Organization and other related organizations requesting that the FDA 

ease restrictions on the availability of silicone gel-filled breast implants for women 

who choose reconstruction after a mastectomy and who have other special medical 

needs. FDA denied this petition. 

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• February 11, 1997: FDA received a Citizen's Petition from CanDo Organization 

requesting that the FDA revoke permission granted to companies to make silicone 

gel-filled breast implants available to women with breast cancer and women who 

previously had implants. FDA denied this petition. 

• May 20, 1997: Hutchinson International’s 510(k) for their saline-filled breast implants 

was cleared for marketing by FDA. 

 

1997: The Department of Health and Human Services (DHHS) asked the Institute of 

Medicine (IOM) to conduct an independent, unbiased review of all past and ongoing 

scientific research regarding the safety of silicone breast implants. A committee of 

experts in relevant scientific and clinical areas was asked to evaluate past and ongoing 

studies of the relationship, if any, between implants and systemic disease; assess the 

biological and immunological effects of silicone and other chemical components of 

breast implants; assess the impact of breast implants, if any, on the offspring of 

women with implants; and assess the accuracy of mammograms. 

•

•

•

•

Spring 1998: FDA completed a study to assess the rupture rate of silicone gel-filled 

breast implants. 

March 30, 1998: FDA approved Inamed Corporation’s adjunct study protocol for 

silicone gel-filled breast implants for reconstruction and revision patients only. 

May 6, 1998: Mentor Corporation and its subsidiary, Mentor Texas, signed a consent 

decree of permanent injunction, promising to manufacture its breast implants in 

compliance with the Quality System Regulation. The Quality System Regulation is 

critical in helping to assure that medical devices are consistently high in quality and 

are safe and effective. FDA permitted Mentor Corporation to continue marketing its 

breast implants because the deficiencies in Mentor Corporation’s manufacturing 

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process were not shown to result in a significantly increased risk to women who 

received this company’s breast implants. 

June 5, 1998: FDA approved Inamed Corporation's IDE study for silicone gel-filled 

breast implants for a limited number of augmentation, reconstruction, and revision 

patients at a limited number of sites. 

•

•

•

•

November 12, 1998: FDA received a Citizen's Petition from Hyman, Phelps & 

McNamara requesting that FDA either withdraw the proposed rule calling for PMAs 

or PDPs for the saline-filled breast implant or reopen the comment period to allow 

interested persons to address the information that has become available since the 

publication of the 1993 proposed call for PMAs or PDPs. FDA denied this petition. 

February 1, 1999: Silimed’s 510(k) for their pre-filled and inflatable saline-filled 

breast implants was cleared for marketing by FDA. 

June 22, 1999: The IOM released a comprehensive report of the published literature 

and ongoing studies on both saline-filled and silicone gel-filled breast implants 

entitled Safety of Silicone Breast Implants. The IOM made a clear distinction 

between local complications and systemic health concerns. The IOM determined that 

there was insufficient evidence to establish that either or both types of breast implants 

cause systemic health effects, such as autoimmune disease, and that there were no 

new health or safety issues associated with the use of both types of implants. The 

IOM also concluded that local complications are “the primary safety issue with 

silicone breast implants.” These local complications, which include rupture, pain, 

capsular contracture, disfigurement, and serious infection, may lead to medical 

interventions and repeat surgeries. 

68 
The IOM report, Safety of Silicone Breast Implants, is available for sale from National 

Academy Press, 2101 Constitution Avenue, N.W., Box 285, Washington, DC 20055 

or call 800-624-6242 or 202-334-3938 or through the web at 

http://books.nap.edu/catalog/9602.html. The IOM report may also be read at the same 

website for free. A consumer booklet on the IOM study, Information for Women 

about the Safety of Silicone Breast Implants, can be purchased from the National 

Academy of Sciences on their website at http://books.nap.edu/catalog/9618.html or 

read at the same website for free. 

June 30, 1999: FDA received a Citizen's Petition from Anne Stanswell requesting that 

FDA ban the use of the silicone gel-filled breast implants. FDA denied this petition. 

•

•

•

October 1999: FDA issued a draft guidance document entitled, “Guidance on 

Preclinical and Clinical Data and Labeling for Breast Prostheses.” This guidance 

document was for saline, silicone gel, and alternative breast implants and replaced 

FDA’s previous three guidance documents for the individual types of breast implants. 

 

August 19, 1999: FDA published a final 515(b) regulation in the Federal Register that 

required manufacturers of saline-filled breast implants to file PMAs or completed 

PDPs within 90 days. The PMAs or PDPs were to include data showing a reasonable 

assurance of safety and effectiveness of the implants. One of the reasons for the time 

span between the January 1993 proposed call for PMAs/PDPs and this final one was 

to give companies time to collect data on their preamendments or 510(k)-cleared 

saline-filled breast implants. 

• December 17, 1999: FDA approved Silimed's IDE study for saline-filled breast 

implants for a limited number of augmentation, reconstruction, and revision patients 

at a limited number of sites. 

69 
March 1-3, 2000: FDA convened a Panel meeting to review a PMA submitted by 

Mentor Corporation, Inamed Corporation, and PIP for their saline-filled breast 

implants and make a recommendation to the FDA whether the PMAs are approvable. 

The Panel recommended that Mentor Corporation’s and Inamed Corporation’s PMAs 

be approved with conditions and that the PIP PMA be disapproved. Additionally, a 

day of this Panel meeting was dedicated to obtaining public input on patient labeling. 

The transcript for this Panel meeting is available at 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=184. 

•

April 28, 2000: FDA approved PIP’s IDE study for saline-filled breast implants for a 

limited number of augmentation, reconstruction, and revision patients at a limited 

number of sites. 

•

May 10, 2000: FDA granted approval of Mentor Corporation’s and Inamed 

Corporation’s saline-filled breast implant PMAs. Both PMAs included data on the 

types and rates of local complications experienced by patients. The 3-year 

complication rates are also summarized in our May 10, 2000 press release available at 

http://www.fda.gov/bbs/topics/NEWS/NEW00727.html. Despite complications 

experienced by some women, the majority of those women still in the Inamed 

Corporation and Mentor Corporation studies after three years reported being satisfied 

with their implants. 

•

Both PMAs were approved for females for the following indications: breast 

augmentation (a woman must be at least 18 years old) and breast reconstruction. 

The approval letter, the labeling at the time of approval, and the Summary of Safety 

and Effectiveness (SSED) are available at http://www.fda.gov/cdrh/pdf/p990075.html

for Mentor Corporation and at http://www.fda.gov/cdrh/pdf/p990074.html

for Inamed Corporation. 

70 
Updated clinical data from Mentor Corporation’s and Inamed Corporation’s ongoing 

postapproval studies for these PMAs are available in the patient labeling on FDA’s 

website at http://www.fda.gov/cdrh/breastimplants, as well as on the websites for both 

companies. 

May 26, 2000: FDA approved Hutchison’s IDE study for saline-filled breast implants 

for a limited number of augmentation, reconstruction, and revision patients at a 

limited number of sites. 

•

August 2, 2000: FDA approved Mentor Corporation’s IDE study for silicone gelfilled breast implants for a limited number of augmentation, reconstruction, and 

revision patients at a limited number of sites. 

•

September 8, 2000: FDA approved Inamed Corporation’s IDE study for morecohesive (firmer) silicone gel-filled breast implants for a limited number of 

augmentation and reconstruction patients at a limited number of sites. 

•

June 29, 2001: FDA approved Mentor Corporation’s IDE study for more-cohesive 

(firmer) silicone gel-filled breast implants for a limited number of augmentation, 

reconstruction, and revision patients at a limited number of sites. 

•

July 18, 2001: FDA approved Mentor Corporation’s IDE study for saline/silicone gelfilled breast implants for a limited number of reconstruction patients at a limited

number of sites. These implants have an inner lumen filled with saline and an outer 

lumen filled with silicone gel. 

•

• August 13, 2001: FDA issued an updated breast implant guidance document entitled, 

“Guidance for Saline, Silicone Gel, and Alternative Breast Implants.” This version 

replaced the October 1999 version. 

71 
September 5, 2002: FDA approved Silimed’s IDE study for silicone gel-filled breast 

implants for a limited number of augmentation, reconstruction, and revision patients 

at a limited number of sites. 

•

•

•

•

•

•

•

December 30, 2002: Inamed Corporation submitted a PMA for their silicone gel-filled 

breast implants. 

February 11, 2003: FDA issued an updated breast implant guidance document 

entitled, “Guidance for Saline, Silicone Gel, and Alternative Breast Implants.” This 

version replaced the August 2001 version. 

April 29, 2003: FDA approved CSS’ IDE study for saline-filled breast implants for a 

limited for a limited number of augmentation, reconstruction, and revision patients at 

a limited number of sites. 

May 14, 2003: FDA approved Inamed Corporation’s IDE study for saline/silicone 

gel-filled breast implants for a limited number of augmentation, reconstruction, and 

revision patients at a limited number of sites. These implants have an inner lumen 

filled with saline and an outer lumen filled with silicone gel. 

August 22, 2003: Consent Decree with Mentor Corporation was vacated by court. 

Mentor satisfied FDA’s requirement that Mentor's Irving, Texas facility be in 

continuous compliance for at least five years with the FDA's current good 

manufacturing practices requirements. 

October 14-15, 2003: FDA convened a Panel meeting to review a PMA submitted by 

Inamed Corporation for a silicone gel-filled breast implant and to make a 

recommendation to the FDA whether the PMA is approvable. The PMA included 

data collected in their core clinical study (the IDE), as well as information from the 

larger adjunct study, medical device reports from a variety of databases, and 

72 
published scientific literature. Approximately 120 members of the public also were 

afforded an opportunity to address the Panel. The Panel voted nine to six to 

recommend approval of the PMA with certain conditions.

A copy of the Panel meeting agenda, Panel package, Panel roster, FDA slides, brief 

summary of Panel meeting, and complete transcript are available at 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=388. 

November 3, 2003: FDA received a Citizen's Petition from Kim Gandy, Sidney 

Wolfe, M.D., and Cynthia Pearson requesting the FDA to stop the review of the 

Inamed Corporation silicone gel-filled breast implant PMA until the information 

described in their petition was provided. FDA denied the petition because FDA is 

required to complete the review of an outstanding application and make a decision. 

•

•

•

•

November 18, 2003: FDA received a Citizen's Petition from Marlene Keeling 

requesting the FDA to stop the review of any silicone gel-filled breast implant PMA 

until the information described in their petition was provided. FDA denied the 

petition because FDA is required to complete the review of an outstanding application 

and make a decision. 

December 12, 2003: Mentor Corporation submitted a PMA for their silicone gel-filled 

breast implants. 

January 7, 2004: As noted on their website at http://www.inamed.com, Inamed 

Corporation announced that they received a "Not Approvable" letter from FDA for 

their silicone gel-filled breast implant PMA and that the letter outlines the additional 

information that Inamed Corporation must provide prior to the FDA's further review 

of its PMA. FDA cannot discuss the specific details of that letter because it is 

considered confidential material. 

73 
January 13, 2004 (pre-publication release date of January 8th): FDA issued an updated 

(and in draft) guidance document entitled, “Saline, Silicone Gel, and Alternative 

Breast Implants.” The substantive new recommendations in the draft guidance 

document involve mechanical testing, modes and causes of rupture, clinical study 

information, postapproval requirements, and labeling. A copy of the draft guidance 

document is available at http://www.fda.gov/cdrh/ode/guidance/1239.pdf. FDA also 

issued a press release regarding this guidance document. The press release is 

available at http://www.fda.gov/bbs/topics/NEWS/2004/NEW01003.html. After the 

comment period, the guidance document will be finalized and then replace the 

February 2003 version. 

•

74 
MEDWATCH

MedWatch is the FDA’s program for reporting serious complications and problems with 

medical products, such as drugs and medical devices. MedWatch data include voluntary 

and mandatory (required) reports by consumers and others. MedWatch data are most 

useful as an early warning system when the hazards of a device are previously unknown. 

FDA also uses these data to follow trends with particular devices and look for signals that 

further follow-up could be needed. 

If you have experienced one or more serious problems related to your breast implants, 

you may ask you healthcare provider (for example, nurse or doctor) to report the 

problem(s) to the manufacturer or to FDA. If you are participating in a study, you should 

report all problems to your doctor so that information will be included as part of the study 

data. 

If you want more information, please visit the MedWatch website at 

http://www.fda.gov/medwatch or call 1-800-332-1088. 

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76 

FREEDOM OF INFORMATION

The Freedom of Information Act (FOIA) allows anyone to request FDA records. 

However, under FOIA, information that is deemed exempt from disclosure may not be 

released to the public. Examples of this type of information typically include: preclinical 

or clinical data from ongoing, completed, or discontinued studies; mechanical drawings; 

and specific chemical compositions. In addition, FDA cannot acknowledge the existence 

of an IDE study unless we know that the company has gone public with that information. 

Even then, in most cases, no details of that study can be given per FDA regulations. We 

are not denying any request; however, this clarification is provided so that you do not 

have unrealistic expectations on what information you can obtain through FOIA. 

To access additional information on FOIA, to check to see if the information you want is 

already on FDA’s website, to find out about FDA public reading rooms, and to access the 

complete handbook for requesting information through FOIA, please go to our website at 

http://www.fda.gov/foi/foia2.htm. You may also obtain FOIA information by calling 1-

888-INFO-FDA (1-888-463-6332). FDA may charge a fee for completing a FOIA 

request.