Silicone implants: Safe, need monitoring
June 22nd, 2011
06:11 PM ET

Silicone implants: Safe, need monitoring

Silicone gel breast implants are safe according to the ongoing monitoring by the FDA.  However, women must understand that silicone breast implants are not lifetime devices and the longer they have them in, the higher the likelihood of developing complications, according to Dr. Jeffrey Shuren, director of the FDA Center for Devices, .

“One in 5 women who received implants for breast augmentation implants will need to have those implants removed within 10 years,” said Shuren.

Complications from implants include the formation of scar tissue around the implant, an implant rupture and the need for more surgery or removal of the insert. Women also experience breast pain, wrinkling and asymmetry. Manufacturers and physicians must continue to provide up-to-date information to patients who are considering breast implants, according to the FDA.

In January, the FDA reported a link to silicone gel implants and a rare cancer that affects the lymph nodes.  Wednesday Shuren said there is no evidence so far that links the implants to breast cancer among other illnesses.   “To date, preliminary data does not indicate that silicone gel-filled breast implants cause breast cancer, reproductive problems or are connected to tissue disease such as rheumatoid arthritis or lupus,”  he said.  He did go on to say, however, that in order to rule out these possibilities entirely, studies must be conducted for a longer period of time.

A statement from Dr. Sidney Wolfe, director of the Public Citizen’s Health Research Group, said the FDA’s assurance of safety is, “unquestionably shortsighted as well as contradictory.” He added, “The FDA’s acknowledged inadequacy of implant company safety studies makes their continued use resemble an experiment on women, rather than a product with a reasonable assurance of safety.”

Dr. Phil Haeck, president of American society for plastic surgeons, says
80% of women still have their implants up to 10 years and they are satisfied.

Last year,  296,000 women received breast augmentations and 90,000 received reconstructive breast surgery according to the American Society of Plastic Surgeons. The announcement by FDA Wednesday is part of the overall monitoring of silicone gel breast implants that will continue at least through 2016.

Twelve years after silicone gel breast implants were introduced in the U.S., they were updated to the highest risk category, Class III in 1988. The back and forth over safety continued through the 90’s. In 2006, the FDA approved two different silicone breast implants only after requiring each manufacturer to conduct studies on safety. Wednesday's announcement by the FDA was part of monitoring of those studies by the manufacturers.

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