FDA: Silicone-gel Breast Implants Relatively Safe

If you want silicone-gel breast implants, get them - just don't expect to keep them forever, according to a new report from the U.S. Food and Drug Administration.

Breast implants, the medical devices surgeons place under the breast tissue or chest muscle of those who want breast size augmentation or breasts rebuilt constructively following mastectomy or other incidents of damage, are safe, the FDA said but not permanent.

They don't cause cancer but if those with implants leave them in for too long the implants could rupture, wrinkle or even harden, causing complications. The findings are from the FDA safety studies required by manufacturers of silicone gel-filled breast implants. The regulatory agency said the longer implants are in the greater the odds for complications.

The study revealed that one in five patients with breast implants installed for the purpose of augmentation will need them removed within a decade, while one of every two of those who received implants for augmentation will need them removed within a decade.

While implants are linked to a rare cancer known as anaplastic large cell lymphoma cases number less than 100 among the nearly 10 million patients who have them, making the threat almost negligible.

Among the most common complications with breast implants is scar tissue that forms around the device which often hardens, potentially damaging physical appearance or causing pain.

The FDA banned silicone-gel breast implants in 1992 over cancer and other diseases fears but research showed otherwise and they were returned to the market in 2006. As part of the agreement to bring them back to market the FDA required follow-up studies to monitor how patients were dealing with them.