- The Washington Times - Wednesday, June 22, 2011

Don’t expect breast implants to last for life, the government warned Wednesday. About 1 in 5 women who receive them for cosmetic reasons will have them removed within 10 years, and those odds are even higher for cancer survivors.

It’s not the first time the Food and Drug Administration has issued such a warning. But the agency repeated it Wednesday after reviewing new data on silicone-gel breast implants five years after they returned to the market following a health scare. The agency concluded the implants are basically safe as long as women understand they come with complications. Those include painful scar tissue and ruptured implants.

“The longer you have the implant, the more likely you are to have complications,” said FDA medical device chief Jeff Shuren. He said women should get regular checkups including scans to make sure the implants haven’t ruptured.

While the FDA’s safety review concentrated on silicone-gel implants, the agency’s updated advice booklet for women makes clear that saline-filled versions come with the same complications - women getting those wind up back on the operating table, too.

Plastic surgeons say they’ve long told women about those risks.

“It doesn’t discourage a single one of them, which is pretty amazing,” said Dr. Michael Zenn, vice chief of plastic surgery at Duke University Medical Center. “This requires almost lifetime maintenance when you have a breast implant in. If you’re not telling patients that, you do them a disservice.”

Wednesday’s update is the latest in a 20-year saga over the safety of breast implants. The FDA banned the silicone-gel type in 1992 amid fears they might cause cancer, lupus and other diseases. But when research ruled out most of the disease concern, regulators allowed the return of the implants to the market in 2006 - with the requirement that manufacturers continue studying recipients to determine how they fare in the long term.

Breast augmentation remains the most popular cosmetic surgery in the U.S., with nearly 300,000 women undergoing it last year. According to the American Society of Plastic Surgeons, more than 70,000 others received implants for breast reconstruction. Silicone-gel implants are the most common kind.

Based on that data, the FDA said Wednesday that 20 percent to 40 percent of patients who have implants for cosmetic reasons will need another operation to modify or remove them within eight to 10 years.

For reconstruction patients, the number is even higher at 40 to 70 percent, the FDA said.

The most common complication remains scar tissue that hardens around the implant and can become severe enough to warp the shape of the breast or cause pain. Other problems include implant rupture, wrinkling and a lopsided appearance, according to the report.

The research also showed a small link with a very rare form of cancer known as anaplastic large-cell lymphoma. The agency has learned of 60 cases of the disease worldwide among the estimated 5 million to 10 million women with breast implants.

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