FDA Warns Breast Implants Not 'Lifetime Devices'

Silicone gel-filled breast implants are not designed to last a lifetime.

(RxWiki News) U.S. Food and Drug Administration officials are warning women that silicone gel-filled breast implants are not designed to last a lifetime.

In a new report designed to augment available safety information, the FDA said that one in five women with silicon implants will need them removed within 10 years of implantation. For those receiving implants with reconstructive surgery, as many as half will require removal within a decade.

"Talk to a doctor about the risks of silicone breast implants."

The report also revealed that the longer a patient has breast implants, the more likely that there will be complications. The most common complications are hardening of the area around the implant, reoperation and implant removal.

Other problems include implant rupture, wrinkling, asymmetry, scarring, pain and infection. Those complications are similar to warnings given when this type of breast implant was initially approved.

The report confirmed that silicone gel-filled implants are safe and effective when used as intended, but urges women to understand the risks before going forward with implants.

Preliminary research does not indicate that silicone gel-filled breast implants cause breast cancer, reproductive problems or connective tissue disease, such as rheumatoid arthritis, but additional studies are needed to rule out those complications.

The report includes preliminary safety data from post-approval studies conducted by each of the two breast implant manufacturers, Allergan and Mentor, which was a condition of the approval process to ensure the safety of the devices. The FDA approved silicone gel-filled breast implants in November 2006 for breast augmentation in women over age 22 and for breast reconstruction in all women.

Women with breast implants are advised to follow up with their doctor and get routine MRIs to detect silent rupture. The FDA also advises women to pay attention to unusual symptoms or side effects.

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Review Date: 
June 22, 2011