An FDA study on rupture of silicone gel-filled breast implants was presented at the Sixth World Biomaterials Congress on May 18, 2000.

The study, performed in Birmingham, Alabama, involved women who had their first breast implant before 1988. The majority of the 907 women in this study had silicone gel-filled breast implants. Some women who had silicone gel-filled breast implants were invited to undergo a magnetic resonance imaging (MRI) examination of their breasts to determine whether their implants had ruptured. MRI allows the radiologist to see the breast implant while it is still inside the breast.

FDA conducted this study because of concerns about the frequency and results of rupture. Rupture is a concern because:

• Rupture of silicone gel-filled implants may allow silicone to migrate through the tissues. The relationship of free silicone to development or progression of disease is unknown.

• Rupture is a device failure – the implant is no longer performing as intended.

Protocol

• Women in this study were identified because they had been in a National Cancer Institute study on women with breast implants. Women who responded to a questionnaire in the NCI study were eligible for this study. This cohort included only women who were patients at two plastic surgery practices. The 907 women in this study were a subset of 1247 women in the Birmingham, Ala., area who were part of an NCI study on breast implants.

• The rupture study had two parts. In the first part, 907 women were interviewed about surgeries in which implant(s) were surgically removed (interview component of the study).

• One third of the 907 women in the first part of the study reported that they had at least one surgery in which their implant was removed and replaced. Women were also asked the main reason they had their implants removed, and if an implant rupture was suspected prior to the surgery.

• If women reported that their implant surgery was for a suspected implant rupture, they were asked about symptoms that they may have had and about whether they knew of a possible cause of the rupture.

• In the second part of the study, 344 women with silicone gel breast implants received MRI examinations to detect possible implant rupture. The women, selected randomly from the first part of the study, were invited to have MRI exams when they were called to be in the study until all the MRI appointments planned for the study had been filled. The study had funding for up to 400 MRI exams to be accomplished at a particular MRI facility under contract for a certain period of time. Of the 445 women invited to have an MRI, 80% (359) accepted and had the examination. Women were invited for the MRI exam without regard to whether they had symptoms of breast implant rupture. Those who accepted the appointments and came were no more likely to think their breast implant was ruptured than women who declined the examination or did not come to their appointments.

• The 344 women who received MRI examinations had a total of 687 implants. The average age of the women in the MRI cohort was 51 ± 8 years. Most women in this cohort had a single lumen gel breast implant (82%) and the remainder had a double-lumen gel breast implant (silicone and saline). For the 677 implants for which this information was available, the average implant age was 17 ± 3 years.

• Three independent radiologists reviewed the results of all of the women’s MRIs and for each implant, determined whether it was intact, indeterminate (suspicious for rupture), or ruptured. The agreement between the radiologists was very high.

Results

• At least two of the three study radiologists agreed that 378 of the 687 implants were ruptured (55%). This means that 69% of the 344 women had at least one ruptured breast implant.

• Radiologists observed that silicone gel had leaked outside the fibrous scar capsule that forms around the implant in 85 of the 687 implants (12%). Of the 344 women, 73 (21%) had silicone gel outside the capsule in one or both breasts.

• Factors that were associated with rupture: the age of the implant, the implant manufacturer, and whether the device was implanted above or beneath the chest muscles.

Limitations of the Study

• This cohort included only women who were at two plastic surgery practices. It is unknown whether the results of the study might have been different if patients from other parts of the U.S. had been included.

• Only 80% of those invited to have an MRI examination agreed.

• Many types of silicone gel-filled breast implants were included in this study.

• While MR imaging is considered the best method for imaging breast implants for rupture, it is not perfect.

Conclusion

• MRI examination in this cohort of patients demonstrated that the majority of women had at least one ruptured implant.

Funding and Authors

• Funding for this study came from: the Office of Women’s Health, FDA; the Office of the Commissioner; the National Cancer Institute, NIH; the Office of Research on Women’s Health, NIH; and the U.S. Department of Health and Human Services.

• Authors were S. Lori Brown, PhD, MPH , Michael S. Middleton, PhD, MD ² , Wendie A. Berg, MD, PhD ³ , Mary Scott Soo, MD ⁴, and Gene Pennello, PhD ¹.

¹Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD 20850

²Department of Radiology, University of California at San Diego School of Medicine, San Diego, CA 92103

³Division of Breast Imaging, Department of Radiology and Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore, MD 21201

⁴Department of Radiology, Duke South Hospital, Duke University Medical Center, Durham, NC 27710

Back to Breast Implant Information Page

From FDA Breast Implant Consumer Handbook 2004 at http://www.fda.gov/cdrh/breastimplants/handbook2004

/localcomplications.html#3

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. (ABOVE STUDY SHOWS A 55% RISK OF RUPTURE—jk)

• 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).

• 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 non-surgical 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

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

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

Photograph 1: Implant removal without replacement in augmentation patient

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

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.

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.

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:

The IOM report²⁶ stated that, for studies involving both silicone gel-filled and saline-filled breast implants, the capsular contracture rates were 36-81% for silicone-gel filled breast implants and 8-41% for saline-filled breast implants.