Breast implants safe but don't last forever, FDA says: What women need to know
(CBS/AP) They're basically safe. That's what the FDA now says about silicone-gel breast implants.
But women shouldn't expect their implants to last forever, the agency warned on Wednesday. In part because of complications like painful scar tissue and ruptures, one in five women who receive breast implants for cosmetic reasons will have them removed within 10 years - and the proportion is even higher for women who get the implants after breast cancer.
PICTURES: 10 most common plastic surgery procedures
"The longer you have the implant, the more likely you are to have complications," said Jeff Shuren, the FDA's medical device chief. He said women should get regular checkups, including scans, to make sure the implants haven't ruptured.
The FDA's safety endorsement is primarily based on studies conducted by the two U.S. manufacturers of the products, Allergan and Johnson & Johnson's Mentor unit.
While FDA's safety review concentrated on silicone-gel implants, the agency 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 on breast implant safety is the latest chapter in a 20-year saga. The FDA banned silicone-gel implants 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 over the long term.
Breast augmentation remains the most popular cosmetic surgery, with nearly 300,000 women in the U.S. undergoing it last year. More than 70,000 others received implants for breast reconstruction, according to the American Society of Plastic Surgeons. Silicone-gel implants are the most common kind.
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.
Implants are also linked to a rare cancer known as anaplastic large cell lymphoma. The FDA 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 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 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 surrounding tissue 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 the breasts change with age or weight gain. Even if the implant doesn't rupture or develop scar tissue, the skin and fat around it can droop or sag. 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 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.