Breast implants are safe and effective but are not lifetime devices.
This is the conclusion from the US Food and Drug Administration (FDA) which has released a report updating the clinical and scientific information for silicone gel-filled breast implants.
The report concludes that while silicone gel-filled breast implants are safe and effective when used as intended, women should fully understand the risks prior to considering silicone gel-filled breast implants for breast augmentation or reconstruction.
Based on the report, it says, women should know that the implants are not for life and that the longer she wears the implant 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 report states that preliminary data does 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, it states that more studies are needed.
The FDA is holding an expert advisory panel in the next few months to discuss how post-approval studies on breast implants can be more effective.