Understanding Allergan’s Textured Breast Implant Recall

Multiple women are suing Allergan, claiming the pharmaceutical company’s textured breast implants gave them a rare form of cancer. While the Food and Drug Administration recalled these implants in July 2019, lawsuits allege that the company knew about the risks as early as the 1990s and failed to warn patients.

Who is Allergen and What are the Concerns with their Breast Implants?

Allergan manufactures many popular medicines and devices geared towards eye care, aesthetics, cardiovascular health, and more. Some of their more popular products include Botox, Lexapro, and Refresh. They also make several different breast implants.

While most breast implants manufactured are smooth, Allergan also offered several textured implant options under the brand names of BIOCELL, Natrelle, McGhan, and Inhamed. Textured implants were marketed to adhere better to the tissue, causing them to stay in place. However, over time, a growing number of women who opted for the textured implants began developing a rare form of cancer.

Anaplastic Large Cell Lymphoma and its Link to Allergen

Allergan’s textured breast implants have been linked to a cancer called Anaplastic Large Cell Lymphoma (ALCL). In fact, the association is so well documented that it’s referred to as Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). To be clear, this cancer is not associated with smooth breast implants, which dominate the market.

Even though BIA-ALCL is triggered by the textured breast implants, it is not a breast cancer. It’s a rare form of lymphoma, a cancer of the immune system. It is thought that over time, the implants cause an allergic-type reaction to the surrounding tissues spurring the growth of cancerous cells.

Here are some sobering statistics about Allergan’s connection to BIA-ALCL:

  • To date, 573 patients worldwide contracted BIA-ALCL. There have been 33 deaths
  • Of the 573 patients who contracted BIA-ALCL, 481 (or 84%) had Allergan’s BIOCELL textured implants
  • 276 of the reported cases were in America (48%)
  • Patients were 6 times more likely to develop lymphoma with Allergan’s BIOCELL implants than other textured breast implants on the market

The good news is that textured breast implants only account for 5% of the implant market. The bad news is that means many thousands of American women may currently have the recalled implants.

What are Some of the Issues with the Recall?

With most recalls, you’re able to return the defective product for a refund. But what do you do if the recalled product is something you’ve had surgically implanted?

The FDA formally issued a recall of Allergan’s textured breast implants in July of 2019, and that halted them from being marketed to new patients. But the FDA did not recommend that women who have the implants remove them. Instead, they urged them to discuss the issue with their health care providers and watch for symptoms. The news has understandably caused many women emotional distress and worry, wondering if the implants are a ticking time bomb.

Furthermore, the FDA issued a recall months after other countries made similar decisions. The FDA had hearings about the safety back in March of 2019 as well. Their delay certainly meant additional patients had the option to elect for the textured implants.

Besides this, the first diagnosed case of BIA-ALCL was clear back in 1997. Critics say Allergan knew there were risks but continued to market their product and failed to warn patients.

What Should you do if you Have Breast Implants?

Here are some practical steps you can take if you have breast implants:

  • Determine which kind of breast implants you have. Remember, the concern is with textured implants, not smooth. The overwhelming majority of patients elect for smooth implants.
  • If you do have textured implants, check to see which ones have been recalled.
  • If you have recalled, textured implants, reach out to your surgeon for advice. They can evaluate your risks and options, based on your personal health history.
  • Know the symptoms. Watch for fluid build-up, pain and soreness, or any unusual lumps.

Some additional information about the recall can be found on the FDA website.

What Should I Do if I Believe my Allergan Breast Implants Gave me Cancer?

If you have Allergan’s recalled textured breast implants and have been diagnosed with BIA-ALCL, please call our attorneys at Ladenburg Law today. You may also wish to speak to us about your options if you have the implants and have no symptoms. We understand your concerns; and are able to speak with you.

We’re able to evaluate your case at no cost to you, and help you determine your legal options.

    Get a Free Case Evaluation