The U.S. Food and Drug Administration is taking a closer look at textured breast implants that are linked to a rare form of cancer. The agency found 450 cases worldwide where implants triggered a form of lymphoma that grows in the scar tissue surrounding the breast.
Twelve of those cases were deadly. The panel said it was too soon to pull the implants from the market, but says it will make a recommendation Tuesday.
The Food and Drug Administration panel didn't recommend any immediate restrictions on breast implants after a day reviewing the latest research on the risks of the devices, which have been subject to safety concerns for decades.
The FDA has been grappling with how to manage emerging science that shows the implants can trigger a rare form of lymphoma that grows in the scar tissue surrounding the breasts.
The agency identified about 450 cases of cancer worldwide, including 12 deaths. Almost all of the cases involve a type of textured implant that is designed to stop implants from slipping and to minimize scar tissue.
But the majority of the 19 panelists - including plastic surgeons and cancer experts - said it was too soon to remove the products from the market. "Do we want to get into the situation where we pull one sweetener and the replacement is even worse?" said Karla Ballman, a biostatistician at New York's Weill Cornell School of Medicine.
"I think a knee-jerk reaction of just pulling something without knowing what the replacement will be might get us into more trouble." Estimates of the frequency of the disease range from 1 in 3,000 women to 1 in 30,000. It grows slowly and can usually be successfully treated by removing the implants.
The FDA said it has also received reports of the disease in smooth implants - which account for most of the US market. Another panelist said a ban on textured implants would be an "extraordinary overreaction."
But that opinion wasn't unanimous. The panel's consumer representative stressed the risk to women who get implants for reconstructive purposes after breast cancer surgery and could face a second cancer.
"I think that's so much of a risk that they need to be taken off the market," said Roberta Brummert. Her comments set off cheers from dozens of women who attended the hearing.
In the US, roughly 400,000 women get breast implants each year - 100,000 women get them after cancer surgery.
On Tuesday, the same FDA panel will make recommendations on studying and defining the risks of long-term chronic conditions with breast implants. Thousands of women have blamed their implants for a host of other chronic ailments, including rheumatoid arthritis, chronic fatigue, and muscle pain.
Patients and advocates have used the recent scrutiny to call for new warnings and restrictions on implants. "Don't ignore us. We are real," said Holly Davis, of Charleston, South Carolina. Davis, 60, said she experienced chronic pain, hair loss, rashes, and memory loss after receiving silicone gel-filled implants following a double mastectomy in 2002.
Davis said she learned her implants had ruptured when they were removed in 2017; her symptoms have since resolved. She and other patients want the FDA to require manufacturers to give standardized risk disclosure information to all women considering implants.
"We need to know what we're signing up for - it can't be a surprise down the road," Davis said.
