Breast implants may cause cancer, Food and Drug Administration (FDA) Sends stronger warning
Breast implants may cause cancer, and the FDA has finally responded to women’s concerns.
The proposal for boxed warnings comes after a grassroots of women online demanding the FDA take action
U.S. health officials want women getting breast implants to receive stronger warnings and more details about the possible risks and complications.
The Food and Drug Administration said Wednesday that manufacturers should add a warning highlighted by a box — the most serious type — to the information given to women considering implants.
The agency also is recommending patients complete a checklist to make sure they understand all the possible side effects of the implants, such as scarring, pain, rupture and even a rare form of cancer.
“We have heard from many women that they are not fully informed of the risks when considering breast implants,” the agency said in a statement detailing the recommendations.
The agency also wants companies to explain that breast implants often require repeat surgeries and they should not be considered lifelong devices. About 1 in 5 women who get implants for cosmetic reasons need to have them removed within 8 to 10 years, according to the FDA.
The agency will take public comment on the proposed guidelines before adopting them.
The new proposal is the FDA’s latest attempt to manage safety issues with the devices primarily used for breast augmentation, the most frequently performed cosmetic surgical procedure in the U.S. Roughly 400,000 women get implants each year; 100,000 after cancer surgery.
In recent years, the FDA and regulators elsewhere have grappled with a link between a rare cancer and a type of textured implant. In July, the FDA called on manufacturer Allergan to pull its Biocell implant after it was tied to heightened risk of a form of lymphoma. The company issued a worldwide recall for the implants, which had already been restricted or removed from numerous countries.
In a separate issue, the FDA has received thousands of reports from women who blame their implants for a host of health problems including rheumatoid arthritis, chronic fatigue and muscle pain.
Earlier this year, the FDA held a meeting at which dozens of women urged the agency to place new warnings and restrictions on implants.
The FDA has stood by its longstanding position that the implants are essentially safe so long as women understand they can have complications. But following the meeting, the agency said women should get more explicit, understandable information about implant risks.
The devices have a silicone outer shell and are filled with either saline or silicone.
Breast Implant Illness is not an official diagnosis. In fact, it has been dismissed by many medical professionals, yet there has anecdotally been a rise in reports of the condition.
Women who say they have BII have formed communities in Facebook groups, and turned to a petition on Change.org, which in part resulted in getting the FDA’s attention and proposed boxed warning that the agency announced today.
“Over the past few years, FDA has received new information pertaining to risks associated with breast implants, including breast implant-associated anaplastic large cell lymphoma (BIA112 ALCL) and systemic symptoms commonly referred to as breast implant illness (BII) that some patients attribute to their implants,” the draft of the proposed guidelines to warn patients explain.
The public can submit supportive comments on the petition by December 23, 2019. The agency is also proposing that doctors provide potential patients with a checklist addressing the risks. The proposal comes after momentum in public outcry since FDA associated implants with ALCL in 2011. In July, the FDA requested that one manufacturer, Allergan, recall textured breast implants linked to the cancer.
Renee Ridgeley, a writer and patient advocate, wrote about her experience in the Washington Post about being diagnosed with breast cancer, which resulted in getting a double mastectomy — but her implants were Allergan Biocell 410s, the same ones on the recall list.
“I had consultations with five breast reconstruction surgeons. None mentioned BIA-ALCL or gave me the Allergan documents,” Ridgeley wrote. “Most women with breast cancer don’t have the luxury of browsing websites looking for additional cancer risks before surgery. We’re too busy with blood tests, biopsies, MRIs, consultations, buying wigs, arranging child care and organizing the chaos before the hellfire of cancer treatment begins.”
Diana Zuckerman, president of the National Center for Health Research in Washington, told Salon in an interview this is one of the biggest problems with the Allergan implants.
“They are very often used with breast cancer patients who wanted reconstruction after mastectomy or bilateral mastectomy or many of whom didn’t need them, but who thought they were doing the cautious, careful thing — getting both breasts removed to prevent cancer from coming back and ending up with a different kind of cancer,” Zuckerman said.
ALCL is found in the scar tissue and fluid near the breast implant, and while it is a rare form of cancer, sometimes it can spread throughout the body.
Ridgeley had her implants removed, but other women haven’t been able to because they are burdened by cost. A surgery to remove breast implants can cost up to $12,000. Many women have shared stories of despair on a Change.org petition, that has more than 70,000 signatures demanding the FDA to put a box warning and mandate a patient-doctor checklist, about being unable to get their breast implants removed due to cost. Many of these women were not informed of the risks, and say they have experienced Breast Implant Illness.
“I have breast implants and can’t afford to have them removed,” one woman from Texas wrote. “I’m in constant pain and can never leave my house to enjoy life because of them.”
“I am signing this because FDA’s biases and lack [of] honesty allowed plastic surgeons to implant with the device that has caused my cancer, Ulcerative Colitis, deteriorated vision, caused blood clotting issues during my pregnancy, and destroyed my joints,” another woman from Arizona wrote. “It is inexcusable!”
More recent studies have reported higher rates of autoimmune disease among women with silicone breast implants, although a causative relationship was not established.
Zuckerman told Salon she is happy the FDA has taken action, but that the agency has failed to be more detailed in its proposal.
“It is not as informative as it should be in describing well-designed studies indicating a risk of systemic illnesses,” Zuckerman told Salon. “It’s true that patients are reporting these illnesses, but there are also large studies with statistically significant findings.”
She pointed to one 2018 large-scale Israeli study, adding she believes industry politics got in the way of the FDA being transparent about research, for example, studies that say there are no issues with women having implants are often “funded by people who have a financial interest in saying there isn’t a problem here.”
Meanwhile, some plastic surgeons say they are happy the FDA has issued the proposal, but that the press around the concerns might be overhyped.
“ I think it’s a great thing,” Dr. Daniel Maman, Board Certified Plastic Surgeon with 740 Park Plastic Surgery told Salon. “Despite the press, breast implants remain incredibly safe.”