FDA says 1 in 5 remove breast implants

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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Most women with silicone implants need more surgery

More than one in five women who had silicone breast implants for cosmetic purposes and half of those who got the implants after a mastectomy needed surgery to remove the implants within a decade, according to a Food and Drug Administration report out Wednesday.

“Recognize that breast implants are not lifetime devices,” says the FDA report on the longest studies on the implant to date. “The longer you have your implants, the more likely it will be for you to have them removed.”

In 2010, U.S. surgeons performed nearly 400,000 breast implant procedures. About three-quarters were for breast augmentation, while the rest were for breast reconstruction. About half the surgeries used silicone gel implants; the other half used implants filled with saline.

Silicone implants were pulled off the market in 1992, after concerns were raised about lack of safety data and worries that leaking silicone was linked to immune-system disease.

But the FDA returned the implants to the market in November 2006 after clinical trials didn't find a link to feared diseases. Plastic surgeons and some women were clamoring for the return of the silicone versions because they say they look and feel more real than saline, which can ripple because it's essentially a sack of salt water.

The approval required implant makers Allergan and Mentor to conduct large 10-year studies following up on patient experiences, and Wednesday's report is the first glimpse at how the breast implants held up.

The FDA says 20 to 40 percent of patients who get silicone implants for cosmetic reasons will need another operation to modify or remove them within 10 years. For women with implants for breast reconstruction, the number is even higher, at 40 to 70 percent. The biggest issue was scar tissue hardening around the implant.

Other complications include implant rupture, wrinkling, asymmetry, pain and infection, the report said. Women with breast implants are also slightly more likely to be diagnosed with anaplastic large cell lymphoma, a rare form of cancer.

Despite the risk of complications, the FDA believes that silicone implants are reasonably safe, the report said.

But women in the studies had a high dropout rate and so other complications or long-term safety issues might be missed, the agency’s report says.

Mentor has three-year data for only one out of every five women in its study, while Allergan has two-year data for three out of every five, according to the FDA’s safety update.

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“Low follow-up rates and other study limitations may limit interpretation of the data and preclude the detection of very rare complications,” the agency concluded.

Without knowing why patients have dropped out of the studies, it’s impossible to reach any conclusions about implant safety, says Diana Zuckerman, president of the nonprofit National Research Center for Women & Families in Washington, D.C.

“Did they stop going to the doctor because their implants were removed?” Zuckerman says. “Did they stop going because they died or got very sick? Or are they so happy with their implants that they skipped follow-up visits?”

The FDA has been working with the companies to improve patients’ participation in the studies and will convene a meeting of outside experts to discuss the issue later this summer, says William Maisel, deputy director for science and chief scientist at the agency’s Center for Devices and Radiological Health.

Most women who get breast implants are in their 20s and 30s, and may mistakenly consider breast implants a one-time investment.

"They need to understand they're going to need many removals and replacements for the rest of their lives," Zuckerman says.

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FDA concludes silicone breast implants mostly safe

By MATTHEW PERRONE and LAURAN NEERGAARD, Associated Press Matthew Perrone And Lauran Neergaard, Associated Press – Wed?Jun?22, 3:48?pm?ET

WASHINGTON – 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 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 returned the implants to the market in 2006 — with the requirement that manufacturers continue studying recipients to see how they fare 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, 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, FDA said.

The most common complication remains scar tissue that hardens around the implant, and that 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.

Why are reconstruction patients so much more likely to need another operation?

Radiation for breast cancer damages the skin so that over time it becomes stiffer, said Dr. Evan Garfein, a plastic and reconstructive surgeon at New York's Montefiore Medical Center. It's not uncommon for a woman who got two implants — so that both sides start out matching — to have the radiated side eventually appear tighter and higher on the chest as the tissue around it contracts. Also, women getting an implant after a mastectomy don't have a natural layer of breast tissue to cushion it.

But Zenn said women getting cosmetic implants also need to understand that their breasts also will change with age or weight gain — and even if the implant doesn't rupture or develop scar tissue, the skin and fat around it can droop or sag in unattractive ways. He advises women considering pregnancy to put off implants, because their breasts tend to change afterward, and says he won't perform large implants that bring a greater risk of later revisions.

The FDA's safety endorsement is primarily based on studies conducted by the two U.S. manufacturers of the products, Allergan Inc. and Johnson & Johnson's Mentor unit.

But industry critics point out that most of the studies are still incomplete, and many women have already dropped out.

For example, only 58 percent of women enrolled in a 1,000-patient study of Mentor's implants are still accounted for after eight years. Two larger studies of 40,000 women, conducted by both Allergan and Mentor respectively, have each lost a significant number of patients after just two to three years.

Dr. Diana Zuckerman of the National Research Center for Women and Families said most medical journals would not publish the studies cited by the FDA because of the missing data.

"Once a medical product is approved, the manufacturers have no incentive to do these required studies properly," Zuckerman said. "So, we end up with useless information, which is what has happened with the largest, most important studies of silicone gel breast implants."

The FDA said it is working with Allergan and Mentor to increase study participation, including allowing participants to answer questions online or over the phone.

The head of the leading U.S. plastic surgery society said many patients skip follow-up appointments because they aren't having any problems.

"When women are happy with their implants they tend to feel that a regular follow-up is pointless — it becomes a nuisance and an unnecessary expense," said Dr. Phillip Haeck, president of the American Society of Plastic Surgeons.

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