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FDA urges caution for silicone breast implant recipients

Cosmetic, cancer patients both face risks, study finds

By Deborah Kotz
Globe Staff / June 23, 2011

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WASHINGTON — Women with silicone breast implants need to know that they probably will not last forever and might need to be removed or replaced within a decade of implantation, according to a report released yesterday by the US Food and Drug Administration. About 20 percent of women who have silicone implants for breast augmentation will have problems that warrant removal, as well as one-half of breast cancer patients who have them for reconstruction.

“We want women to fully understand the risks and complications prior to undergoing implants,’’ Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said during a press conference.

Potential problems include a hardening of the breast tissue around the implant — known as capsular contracture — implant rupture, asymmetry, wrinkling, scarring, pain, and infections. Any of these complications could require additional surgery to fix the implant or remove it.

Women who have silicone implants need to follow up with their surgeons if they have any symptoms like pain, asymmetry, or hardness, Shuren said. They should also have a magnetic resonance imaging scan every three years to check for silent ruptures.

Also troubling is the possibility — which Shuren called “profoundly small’’ — of developing a rare type of lymphoma in the breast that has been associated with silicone implants. The FDA has identified 60 cases of cancer out of 5 million to 10 million women who have the breast implants worldwide. That cancer, called anaplastic large-cell lymphoma, normally occurs in the breast in only 3 in 100 million women, so the dozens of extra cases raised red flags.

But Shuren emphasized that silicone implants remain “safe and effective.’’

The agency’s new data comes from manufacturer follow-up studies involving 40,000 women that were required by the FDA after it approved two new silicone implants five years ago. The implants, manufactured by Allergan and Mentor Worldwide, were approved for augmentation in women over age 22 and for breast cancer patients of all ages.

Prior to that, silicone implants — which have a softer and more natural feel than saline — had been banned for augmentation use after concerns were raised about their safety risks, which turned out to be overblown.

About half of women now get silicone, and the rest get saline.

Consumer health activist Dr. Sidney Wolfe, head of the Public Citizen Health Research Group, said in a statement that silicone implants should never have been allowed back on the market for cosmetic augmentation, adding that the FDA’s assurance of safety while at the same time acknowledging that the longer a woman has the implants, the more likely she is to experience complications, is “unquestionably shortsighted as well as contradictory.’’

Both Allergan and Mentor released statements saying they agreed with the FDA’s analysis. “We concur with [the] FDA that women should fully understand there are potential risks associated with breast implants and they should discuss risks and benefits with their plastic surgeon prior to breast augmentation or reconstruction,’’ said Mentor spokesperson Christopher Allman.

The FDA also detailed problems with large dropout rates in the manufacturer studies, which means that the safety data might not be reliable. “We are continually reviewing our metrics and processes in all aspects of our Breast Implant Follow Up Study to increase patient compliance,’’ said Allergan spokeswoman Caroline Van Hove. Allman said Mentor is working with the FDA to improve follow-up rates.

The FDA recommends that women who experience serious side effects with breast implants report them to the agency at www.fda.gov/safety/MedWatch or by calling 800-332-1088.

Deborah Kotz can be reached at dkotz@globe.com.