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FDA issues updated report on silicone gel-filled breast implants

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The FDA has updated the clinical and scientific information for silicone gel-filled breast implants. The updated report includes preliminary safety data from studies conducted by implant manufacturers as a condition of their November 2006 approval, according to a press release.

The report aims to ensure that women with silicone gel-filled breast implants — or those considering them — are informed of all possible complications and outcomes. The agency has redesigned its website to include comprehensive information on silicone gel-filled and saline-filled breast implants.

Although the report confirms that silicone gel-filled breast implants are safe and effective when used as intended, women should understand the risks before they consider silicone gel-filled implants for breast augmentation or reconstruction.

According to the FDA, women should know:

• Breast implants are not lifetime devices. The longer a woman has silicone gel-filled breast implants, the more likely she is to experience complications. One in five patients who receive implants for breast augmentation will need them removed within 10 years of implantation. For patients who receive implants for breast reconstruction, as many as one in two will require removal 10 years after implantation.
• The most frequently observed complications and outcomes are capsular contracture, reoperation and implant removal. Other common complications include implant rupture, wrinkling, asymmetry, scarring, pain and infection.
• The complications that existed for women receiving breast implants at the time of approval are similar to the complications observed today.
• Preliminary data do not indicate that silicone gel-filled breast implants cause breast cancer, reproductive problems or connective tissue disease, such as rheumatoid arthritis. However, to rule out these and other rare complications, studies would need to enroll more women and be longer than those conducted thus far.

The report includes preliminary safety data from post-approval studies conducted by Allergan and Mentor, along with a summary and analysis of adverse events received by the FDA over the years, and a comprehensive review and analysis of recent scientific publications that discuss the safety and efficacy of silicone gel-filled breast implants.

When approved, the FDA requires that both manufacturing companies conduct six post-approval studies to determine the long-term performance and safety of the implants. Since then, both companies have contacted the FDA to discuss the difficulties in following women who have received silicone gel-filled breast implants. The FDA is working with Allergan and Mentor to address those challenges and increase patient participation and follow-up, according to the press release.

“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,” Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in the release. “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.”

In the next few months, an advisory panel will meet to discuss how to improve the efficacy of post-approval studies on breast implants.

In the meantime, the FDA is recommending that health care professionals and women who have silicone gel-filled breast implants do the following:

• Follow up. Women should continue to routinely follow up with their health care professionals. This includes getting routine MRIs to detect silent rupture.
• Be aware. Breast implants are not lifetime devices. Breast implants are associated with significant local complications and outcomes, including capsular contracture, reoperation, removal and implant rupture. Some women also experience breast pain, wrinkling, asymmetry, scarring and infection.
• Pay attention to changes. Women should notify their health care professionals if they develop any unusual symptoms. All serious side effects should be reported to the breast implant manufacturer and MedWatch. Report online or by calling 800-332-1088.
• Stay in touch. If a woman has enrolled in a manufacturer-sponsored post-approval study, she should continue to participate. These studies are the best way to collect information about the long-term rates of complications.

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