Women struggle to get potentially cancer-causing breast implants removed, four years after recall

Concerns about the safety of breast implants have been reignited as warnings grow about links to cancer.

The U.S. Food and Drug Administration (FDA) said this month cases of squamous cell carcinoma may be linked to implants, noting that it had identified 19 cases in the scar tissue around the implants. The report is an update to an FDA warning in September 2022 about various types of cancer forming around breast implants. The agency says occurrences are rare but the “cause, incidence, and risk factors remain unknown.”

Recent updates are separate from growing reports of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), an immune system cancer which has been a known issue with textured implants for a decade, but those products weren’t removed from the market until 2019.

Allergan, one of the world’s largest breast implant manufacturers, issued a voluntarily global recall of textured implants and tissue expanders after growing research linking the products to BIA-ALCL. As of April 2022, at least 1,130 instances of the disease have been reported globally and more than 59 women have died.

Dominique Reed, a Durham woman with the recalled implants, says she never received communication from the manufacturer about the recall, instead learning by word of mouth and on the news.

“I think most people would be pretty scared to hear that they have something inside of them that has been directly linked with cancer,” Reed said.

A 2021 study in the European Journal of Breast Health shows estimates of risk and incidence have increased, affecting one in 355 patients with textured implants after reconstruction.

Reed originally sought plastic surgery after treatment for breast tumors left a divot in her breast in 2010. Textured implants are often used in reconstructive surgeries because of the way they can adhere to the skin and the low risk of scarring.

Dena Young, senior counsel in Berger Montague’s consumer protection practice group, is representing hundreds of women, including Reed, in class-action and personal injury lawsuits against Allergan.

Young says many of her clients are breast cancer patients who got textured Allergan products after a mastectomy.

“So now, you’re putting a cancer survivor at risk for additional cancer and they did not know about this risk when they sought reconstruction,” Young said.

The FDA does not recommend removal or replacement for asymptomatic patients because of the risks of an additional invasive surgery.

“Many of these women don't want to wait and see if they develop the disease before before getting them removed,” Young said. “I have clients who have died from this disease.”

BIA-ALCL isn’t a quick development, and the chances of the cancer forming goes up the longer they remain in the body. Young said many of her clients feel they are “ticking time bombs.”

Reed already had a family history of cancer and as a single mother, she feared the worst. She was also experiencing severe pain and swelling in her breasts, two symptoms of the disease. She went back to the surgeon that placed the implants to discuss her options, but felt her concerns were dismissed.

“It felt really dehumanizing,” Reed said. “I felt like I didn't matter.”

Despite discouragement and delay from the pandemic putting off elective surgeries, she moved forward with getting the implants removed. The surgery wasn’t covered by Allergan or her insurance company, costing her more than $10,000.

“It was a big financial decision to be able to go back and have this corrected out of my own pocket,” Reed said.

Allergan covers the costs of patients wishing to replace implants with their smooth-walled products, but Reed said she did not trust the manufacturer after the recall.

Reed said her experience with her initial removal surgery was a nightmare and expressed concerns about her results and the aftercare she was provided.

“I took off my bandages and was horrified,” Reed said. “I looked like I had four breasts and my skin kind of looked melted.”

Reed sought care from a different provider, Dr. Rhett High with the Raleigh Plastic Surgery Center, and learned that she needed another surgery to correct her issues.

High says said had consultations with several women with the recalled implants.

“Some patients feel comfortable monitoring the implants without the need for an operative intervention and then other patients depending on their own personal risk feel more comfortable just removing these implants, getting them out, and not having this worry in the back of their minds,” High said.

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 recovery away from work and normal-life activities.

Now, she’s hoping that speaking out about her story and fighting back in the courtroom against Allergan 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 is recalled, you get to go into the dealership, and they fix it for free.

"It’s crazy to me that as a woman, as a living human being, if a device is recalled because it could cause death or serious harm that I have to pay out of pocket to get it fixed.”

Young says some clients who have developed BIA-ALCL are getting insurance denials for cancer treatment because the implants are considered cosmetic.

“What does that say about how much we value women’s bodies, women’s lives?” Reed said.