Concerns about the safety of breast implants have been reignited as warnings of links to cancer mount.
The US Food and Drug Administration (FDA) said this month cases of squamous cell carcinoma could be linked to implants, noting that it had identified 19 cases in scar tissue around the implants. The report is an update of a September 2022 FDA warning about various types of cancer that form around breast implants. The agency says occurrences are rare, but “cause, incidence and risk factors remain unknown.”
The recent updates differ from the increasing reports of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a cancer of the immune system that has been a known problem with textured implants for a decade, but these products were not withdrawn from the market until 2019 .
Allergan, one of the world’s largest manufacturers of breast implants, has issued a voluntary worldwide recall of textured implants and tissue expanders after research linked the products to BIA-ALCL. As of April 2022, at least 1,130 cases of the disease have been reported worldwide and more than 59 women have died.
Dominique Reed, a Durham woman with the recalled implants, says she never received notice of the recall from the manufacturer, but found out through word of mouth and on the news.
“I think most people would be pretty scared to hear that they have something directly linked to cancer,” Reed said.
A 2021 study in the European Journal of Breast Health shows that risk and incidence estimates have increased, affecting one in 355 patients with textured implants after reconstruction.
Reed originally turned to plastic surgery after treatment for breast tumors left a hole in her chest in 2010. Textured implants are often used in reconstructive surgeries because they adhere to the skin and the risk of scarring is low.
Dena Young, senior counsel in Berger Montague’s consumer protection practice group, represents hundreds of women, including Reed, in class action and personal injury claims against Allergan.
According to Young, many of her clients are breast cancer patients who received Allergan textured products after a mastectomy.
“So now you’re exposing a cancer survivor to another cancer risk, and they didn’t know about that risk when they were trying to reconstruct,” Young said.
Because of the risks of additional invasive surgery, the FDA does not recommend removal or replacement in asymptomatic patients.
“Many of these women don’t want to wait and see if they develop the disease before having it removed,” Young said. “I have clients who have died from this disease.”
BIA-ALCL is not a rapid development, and the longer they remain in the body, the more likely it is that cancer will form. Young said many of her clients felt they were “ticking time bombs.”
Reed had a family history of cancer, and as a single mom, she feared the worst. She also experienced severe pain and swelling in her breasts, two symptoms of the disease. She went back to the surgeon who placed the implants to discuss her options, but felt like her concerns had been put aside.
“It felt really dehumanizing,” Reed said. “I felt like I didn’t matter.”
Despite the discouragement and delay caused by the pandemic delaying elective surgeries, she continued with the removal of the implants. The surgery was not covered by Allergan or her insurance company and cost her more than $10,000.
“It was a big financial decision to be able to go back and have this fixed out of pocket,” Reed said.
Allergan covers the costs for patients who want to replace implants with their smooth-walled products, but Reed said she didn’t trust the manufacturer after the recall.
Reed said her experience with her first removal surgery was a nightmare and expressed concern about her results and the follow-up care she was provided.
“I took off my bandages and was horrified,” Reed said. “I looked like I had four breasts and my skin looked kind of melted.”
Reed sought help from another provider, Dr. Rhett High of the Raleigh Plastic Surgery Center, and was told she needed another operation to fix her problems.
High said he consulted with several women with the recalled implants.
“Some patients are comfortable monitoring the implants without the need for surgery, and other patients are more comfortable just removing those implants, getting them out, and not having that concern in the back of their minds, based on their personal risk. ‘ said High.
Reed says she was much happier with the outcome of her second surgery and is starting to feel like herself again. But both surgeries cost her more than $20,000 out of pocket and weeks of convalescence away from work and activities of normal living.
Now she hopes that speaking out about her story and standing up to Allergan in the courtroom will help other women with potentially cancer-causing implants.
“Financial compensation for surgery is the least we can expect from Allergan,” Reed said. “If your car has a part that’s being recalled, you can go to the dealer and they fix it for free.
“It’s crazy to me that as a woman, as a living person, when a device is recalled because it could cause death or serious damage, I have to pay out of my own pocket to have it repaired.”
Young says some clients who developed BIA-ALCL are getting denied insurance for cancer treatment because the implants are considered cosmetic.
“What does that say about how much we value women’s bodies and women’s lives?” Reed said.