Summary of Key Findings 1. Based on the totality of the evidence, the FDA believes that silicone gel-filled breast implants have a reasonable assurance of safety and effectiveness when used as labeled. Despite frequent local complications and adverse outcomes, the benefits and risks of breast implants are sufficiently well understood for women to make informed decisions about their use. 2. The longer a woman has breast implants, the more likely she is to experience local complications or adverse outcomes. Women with breast implants will need to monitor their breasts for local complications for the rest of their lives. 3. The most frequent complications and adverse outcomes experienced by breast implant patients include capsular contracture, reoperation, and implant removal (with or without replacement). Other frequent complications include implant rupture, wrinkling, asymmetry, scarring, pain, and infection, among others. These observations are consistent with the local complications and adverse outcomes that were known at the time of approval. 4. Women with breast implants may have a very small but increased likelihood of being diagnosed with anaplastic large cell lymphoma. 5. In the post-approval Core Studies, between 20 to 40 percent of augmentation patients and 40 to 70 percent of reconstruction patients had reoperations during the first 8 to 10 years after they received their implants. Although routine replacement is not necessary, many women will need additional surgery to modify, remove, or replace their implants. 6. There is no apparent association between silicone gel-filled breast implants and connective tissue disease, breast cancer, or reproductive problems. Associations that are very rare or that take many years to manifest may not be detected using currently available data. 7. MRI continues to be the most effective method of detecting silent (asymptomatic) rupture of silicone gel-filled breast implants. 8. Interpretation of the data from the silicone gel-filled breast implant post-approval studies may be limited by low follow-up rates. . Recommendations for Patients Who Have or Who Are Considering Breast Implants • Be aware that breast implants are associated with significant local complications, and the longer the devices remain implanted, the more likely you are to experience a complication. Local complications and adverse outcomes include capsular contracture, reoperation, removal, and implant rupture. Many women also experience breast pain, wrinkling, asymmetry, scarring, and infection. • Continue to receive routine follow-up with your physician. This includes having periodic MRI exams to detect “silent rupture” of the implant. • Notify your health care provider if you develop any unusual signs or symptoms including pain, asymmetry, hardness or swelling. • Recognize that breast implants are not lifetime devices. The longer you have your implants, the more likely it will be for you to have them removed. • If you have enrolled in an Allergan or Mentor post-approval study, continue to participate. These studies are the best way to collect information about the long-term rates of complications. • Continue routine screening mammography for breast cancer at intervals recommended by your health care provider based on your age and risk factors.
Posted on: Wed, 20 Aug 2014 09:00:56 +0000
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