Experts Worry About Rising Number of Cancers Linked to Textured Breast Implants

hand holding a breast implant

A cancer associated with textured breast implants appears to be more common than health officials originally thought. In January, a report from Health Canada noted more than 100 new cases of “breast implant-associated anaplastic large cell lymphoma” (BIA-ALCL). Roughly half of those claims were reported to the agency within the past 6 months.

Those reports have raised questions over whether or not the Canadian government should continue to describe the cancer as “rare,” as it does in official documents. More alarming is the slow global response to the revelations of the implants’ potentially carcinogenic properties.

Which Implants Are Associated With BIA-ALCL, or ‘Breast-Implant’ Cancer?

The World Health Organization (WHO) first classified BIA-ALCL as a unique cancer back in 2016. But implants linked to the illness, perhaps buoyed by a lack of media coverage, continued to be sold until last year. European authorities pulled the implants in December of 2018. Canada followed with its own ban in May of 2019.

Allergan, the Irish pharmaceutical company that produces most of the textured breast implants associated with the cancer, voluntarily recalled the products in August of last year. That recall followed a request by the U.S. Food and Drug Administration (FDA) to do so after it conducted its own research.

In a statement, the FDA said it had analyzed the risk of BIA-ALCL in patients with the Allergan BIOCELL implants, finding it to be 6 times higher than in patients with textured implants from other manufacturers that sell such products in the U.S.

The FDA wrote:

“Continued distribution of Allergan’s BIOCELL textured breast implants would likely cause serious, adverse health consequences and potentially death from BIA-ALCL.”

While global data on textured breast implants is still being gathered, analyses from health agencies in both Europe and North America point to a growing trend. According to a July report from the American Society for Plastic Surgeons (ASPC), there have been 573 confirmed cases of BIA-ALCL worldwide, and 33 of those patients have died.

Are Cases of BIA-ALCL Still ‘Rare’?

Some experts think cases may be underreported or not yet diagnosed. The reason has much to do with the use of the word “rare.” Governments and health organizations continue to describe the cancer as a “serious but rare” type of non-Hodgkin’s lymphoma.

As a result, doctors are reluctant to diagnose or take seriously a condition that other experts are describing as uncommon.

Terri McGregor, a patient who was diagnosed with BIA-ALCL in 2015, summed up the problem in an interview with the CBC:

“We have women in Canada presenting symptoms to their physician, and the physician is telling them that they don’t have cancer and … that they should get on with their lives because of the word rare. What I will tell you is, [for] every single diagnosed woman I know there was a little bit of luck involved, in that she landed at the right time and right place—and that is no way to diagnose cancer.”

Year after year, breast enhancement is listed as the most common cosmetic procedure in the United States, with more than 300,000 operations annually.

CNN reports that the specific type of cancer-causing breast implant represented roughly 5% of all breast implants sold up until it was recalled last year. That means around 15,000 women with breast implants face an elevated risk of developing a very deadly form of cancer.

Allergan Breast Implant Lawsuits

The lack of concrete data only elevates the fear patients, doctors, and health officials are having. The FDA itself notes that the real number of BIA-ALCL cases is not truly known, because officials do not know how many women have received implants — let alone whether or not the implants were textured or smooth.

“We are continuing our assessment to determine whether the risk of developing BIA-ALCL is limited to specific models of textured, or all textured breast implants,” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in a statement last year. “We continue to advise women and health care professionals that the use of breast implants is associated with a risk of developing BIA-ALCL and that the risk is greater with textured implants.”

This connection dates back to 2011, when the FDA first reported the potential connection between breast implants and cancer of the lymphatic system. Since then, women around the U.S. have sought financial compensation through Allergan breast implant lawsuits.

Many Women Remain at Risk

What risk assessments currently exist are broad but, nevertheless, indicate an undeniable correlation.

As The New York Times reports, the best estimate put forth by the FDA is that the lymphoma occurs in one in 3,817 to 30,000 women with textured implants. Health Canada, meanwhile, puts the estimate at roughly one in 3,500.

But Dr. Peter Cordeiro, a reconstructive breast surgeon in New York who claims to have had that many patients, estimated that BIA-ALCL is at least 10 times more prevalent that what official statistics report.

“What’s been the experience of 3,546 patients?” Cordeiro said at a conference on BIA-ALCL in Rome last October, as quoted by the CBC. “Ten now have BIA-ALCL. I’ve submitted this data for publication, but I can tell you, I’ve had one more patient since.”

And that’s just in the U.S.

Dr. Julia Khanna, a plastic surgeon in Oakville, Ontario, told the CBC that she had been using textured implants since the late 1990s, and only stopped once the WHO announced the elevated cancer risk in 2016. Khanna explained her concern in a quote for the CBC:

“I think the numbers that we’re getting from Health Canada are really scary, even worldwide, because they’re changing so quickly.”

Author:Sokolove Law

The Sokolove Law Content Team consists of writers and editors who work alongside the firm’s attorneys and case managers. The team strives to present the most accurate and relevant information for those who need legal help.

Last modified: February 28, 2020

View 10 Sources
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  8. TMC (Texas Medical Center) News, “Textured breast implants associated with rare cancer pulled from shelves.” Retrieved from https://www.tmc.edu/news/2019/07/textured-breast-implants-associated-with-rare-cancer-pulled-from-shelves/. Accessed on Jan 22, 2020.

  9. U.S. Food and Drug Administration, “The FDA Requests Allergan Voluntarily Recall Natrelle BIOCELL Textured Breast Implants and Tissue Expanders from the Market to Protect Patients: FDA Safety Communication.” Retrieved from https://www.fda.gov/medical-devices/safety-communications/fda-requests-allergan-voluntarily-recall-natrelle-biocell-textured-breast-implants-and-tissue. Accessed on Jan 22, 2020.

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