When the Food and Drug Administration allowed silicone gel-filled breast implants back on the market in November 2006, the agency required the manufacturers to conduct follow-up studies to learn more about the long-term performance and safety of the devices.
Today, FDA released a report that includes preliminary safety data from these studies, as well as other safety information from recent scientific publications and adverse events reported to FDA.
FDA approved silicone gel-filled breast implants for increasing breast size (augmentation) in women age 22 or older and for reconstruction (after breast cancer surgery or other medical issues) in all women. They are also approved for revision surgeries, which correct or improve the result of an original augmentation or reconstruction surgery.
Almost five years later, FDA’s report continues to support the safety and effectiveness of these implants when used as intended, but states that women should fully understand the risks before considering getting them.
- Breast implants are not lifetime devices. The longer a woman has them, the more likely she is to have complications and need to have the implants removed or replaced. Women with breast implants will need to monitor their breasts for the rest of their lives.
- The most frequently observed complications and adverse outcomes are tightening of the area around the implant (capsular contracture), additional surgeries, and implant removal. Other complications include a tear or hole in the outer shell (implant rupture), wrinkling, uneven appearance (asymmetry), scarring, pain, and infection.
- Studies to date do not indicate that silicone gel-filled breast implants cause breast cancer, reproductive problems, or connective tissue disease, such as rheumatoid arthritis. However, no study has been large enough or long enough to completely rule out these and other rare complications.