DON’T expect breast implants to last for life.
The American government has warned that about one in five 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 US Food and Drug Administration has issued such a warning. But the agency renewed its concern after reviewing new data on silicone-gel breast implants five years after they returned to the market following a health scare.
The agency concluded that 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 check-ups, 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 in North Carolina.
“This requires almost lifetime maintenance when you have a breast implant in. If you’re not telling patients that, you do them a disservice.”
The 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 US, 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 has said that 20% to 40% of patients who have implants for cosmetic reasons will need another operation to modify or remove them within eight to 10 years.
Australian statistics are not readily available, but according to NationMaster Health Statistics, 66.2 people in every 100,000 have had plastic surgery in Australia, which puts us seventh on the ladder when it comes to going under the knife. That’s 12 places higher than the US, which comes in at 19th.
For reconstruction patients, the number is even higher at 40 to 70%, 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 10 million women with implants.
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