After a push from the U.S. Food and Drug Administration (FDA), medical device manufacturer Allergan on July 24 issued a worldwide breast implant recall of its Biocell textured implants, Yahoo news reports.

2019 Allergan Breast Implant Recall

Allergan’s worldwide breast implant recall comes after years of outcry from patients, doctors, and victim advocates claiming that the company’s textured implants may increase the risk of cancer.

Before the July recall, 38 countries had already banned Allergan’s Biocell textured breast implants due to the link with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

In March 2019, the FDA held a two-day hearing during which patients and medical professionals spoke about the risks of breast implants. According to the FDA, 573 cases of BIA-ALCL have been reported worldwide, with 33 of these cases resulting in deaths. Allergan implants were linked to 481 of the reported cancer cases.

Of the 33 deaths, the type of implant was known in 13 cases. Twelve of the 13 women who died had Allergan implants.

Despite the risks associated with Allergan textured breast implants, the FDA does not recommend breast implant removal for patients who do not have symptoms of BIA-ALCL, according to medical and science news site medicalxpress.com.

“The FDA does not recommend removal for patients without symptoms due to potential risks, but we provide helpful information for patients and providers to consider when discussing next steps.” says Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

Many women with Allergan implants were emotional after hearing about the breast implant recall. Some took to social media to express feelings of anger, relief, and vindication. Other with Allergan implants commented on the feasibility of recalling a device that must be surgically removed from patients’ bodies.

Although Allergan’s recall will ensure that unused implants will be removed from doctors’ offices and suppliers, the FDA has not recommended that women who already have the implants get them removed.

Breast Implants and BIA-ALCL

Approximately 10 million women across the world have breast implants, and an additional 400,000 in the U.S. receive them each year. Allergan breast implants account for approximately 5 percent of the breast implants in the U.S. According to the FDA, the risk of developing BIA-ALCL is approximately six times higher for patients with Allergan Biocell textured implants compared to patients with textured implants from other manufacturers.

If you have Allergan breast implants and have been diagnosed with BIA-ALCL or other side effects from the implants, you may qualify to hire an attorney and pursue compensation. Victims who file lawsuits against Allergan and other manufacturers of textured breast implants may be able to collect compensation for injuries, pain and suffering, and other damages.

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This article is not legal advice. It is presented
for informational purposes only.