Boston — Silicone breast implants probably will not last forever, and may need to be removed or replaced within a decade of implantation, according to a report released last week by the Food and Drug Administration (FDA).
The agency says silicone implants remain “safe and effective.” But about 20 percent of women who undergo augmentation with the devices will develop problems that warrant removal, as will about half of breast cancer patients who receive implants for reconstruction, the Boston Globe reports.
Problems can include capsular contracture, implant rupture, asymmetry, wrinkling, scarring, pain and infections, any of which could necessitate additional surgery.
An FDA spokesman said the risk of developing anaplastic large cell lymphoma — a rare complication associated with silicone implants — is “profoundly small.”
The agency’s new data come from manufacturer follow-up studies involving 40,000 women. The FDA required the studies after approving two new silicone implants, manufactured by Allergan and Mentor, five years ago. Prior to that, the devices had been banned due to concerns about safety.
About half of women receiving implants now get the silicone devices.