As a followup to their approval in 2006 of a pair of silicone gel-filled breast implants, the FDA released updated safety data with some interesting findings.
- 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 5 patients who received implants for breast augmentation will need them removed within 10 years of implantation. For patients who received implants for breast reconstruction, as many as 1 in 2 will require removal 10 years after implantation.
- The most frequently observed complications and outcomes are capsular contracture (hardening of the area around the implant), reoperation (additional surgeries) 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, in order to rule out these and other rare complications, studies would need to enroll more women and be longer than those conducted thus far.
It is important to note that this relates to Silicone Gel-filed implants, not the older saline filled implants, which have similar failure rates, but different failure modes. Overall the FDA recommends MRI screening of implants 3 yrs after implantation and every 2 yrs after that.
FDA press release:FDA provides updated safety data on silicone gel-filled breast implants…
Executive summary: Update on the Safety of Silicone Gel-Filled Breast Implants…
