New FDA Reports About Silicone Gel-Filled Breast Implants

(July 20, 2011) Last month, the U.S. Food and Drug Administration released an updated report regarding the safety data for silicone gel-filled breast implants. Although the report gave the ‘OK’ when used as intended, any woman considering breast implants should know the important findings from this report.

 

  • Breast implants do not last an entire lifetime. One in five patients who receive implants for augmentation will need them removed within 10 years of implantation.

 

  • Almost 50% of patients who receive implants for reconstruction will require removal within 10 years of implantation.

 

  • The most common symptoms or complications are capsular contracture (hardening of the area around the implant), re-operation (additional surgeries), and implant removal. There have also been numerous reports of implant rupture, wrinkling, asymmetry, scarring, pain, and infection.

 

  • So far, the preliminary data does not show any relation to silicone gel-filled breast implants and breast cancer, reproductive problems, or connective tissue disease, but these studies need more women to participate for longer periods of time to confirm these findings.

 

As part of the FDA’s November 2006 approval of silicone gel-filled breast implants for breast augmentation in women over age 22 and for breast reconstruction in all women, they required each of the two breast implant manufacturers (Allergan and Mentor) to conduct six post-approval studies. This was conducted to gain new information on long-term performance and safety of these implants.

 

However, both manufacturers of told the FDA of the difficulty in following up with these women. The FDA is working with both Allergan and Mentor to try to increase patient follow-ups.

 

In the next few months, the FDA will hold an expert advisory panel to make these follow-up studies more effective and beneficial for everyone involved. But more importantly, gathering as much information as possible will ensure that future silicone gel-filled breast implant patients can be properly informed as to all risks and health concerns involved with the procedure.

 

In response to the lack of participation by women who have had these gel-filled silicone implants, Jeffrey Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiology Health said, “The FDA will continue to monitor and collect safety and performance information on silicone gel-filled breast implants, but it is important that women with breast implants see their health care providers if they experience any symptoms. Women who have enrolled in studies should continue to participate so that we may better understand the long-term performance of these implants and identify any potential problems.”

 

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