Allergan Failed to Conduct FDA Required Studies on Recalled Breast Implants

The FDA sent a warning letter to Allergan this week, accusing the company of failing to comply with orders to conduct post-approval studies on its Natrelle breast implants, which were recalled last year due to a higher-than-expected risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). If you or someone you love has been diagnosed with BIA-ALCL and you believe a defective breast implant to be the cause, do not hesitate to seek legal help. Allergan’s textured breast implants were recalled last year after the FDA discovered that nearly all reported cases of BIA-ALCL worldwide were tied to the implants. Contact an experienced breast implant BIA-ALCL attorney as soon as possible to find out if you are eligible for compensation through a product liability lawsuit.

FDA Ordered Allergan to Conduct Post-Approval Studies

According to the FDA’s warning letter, the agency approved Allergan’s Natrelle Silicone-Filled Breast Implants and Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants under two different premarket approval applications, on November 17, 2006, and February 20, 2013, respectively. In addition to periodic reporting requirements, the FDA ordered Allergan to “conduct certain post-approval studies in accordance with 21 C.F.R. § 814.82(a), to provide information on the long-term device performance, and to evaluate device performance under general conditions of use.” According to the FDA, Allergan failed to comply with the post-approval study requirements, which required the company to:

  • Conduct a 10-year large postapproval study to evaluate certain safety endpoints.
  • Collect data on the following safety endpoints: long-term local complications, connective tissue diseases (CTDs), CTD signs and symptoms, neurological disease, neurological signs and symptoms, offspring issues, reproductive issues, lactation issues, cancer, suicide, mammography issues, and MRI compliance and rupture results.
  • Collect local complication data from physician evaluations at one, four and 10 years.

Potential Risk of Breast Implant Cancer

In the warning letter sent to Allergan, the FDA says that Allergan’s failure to conduct the proper post-approval studies “prevents adequate evaluation of the safety, effectiveness, and reliability of the device at this late stage in the study period and will prevent such an evaluation at the end of the study.” In a press release issued by the FDA on May 14, Dr. Binita Ashar, director of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health, said, “Post-approval studies are especially important to inform our understanding of the long-term potential risks associated with Allergan’s implants, including the models that have since been recalled from the market due to increased risk of breast implant associated anaplastic large cell lymphoma.”

Unfortunately, we now know that women implanted with the devices may face an increased risk of breast implant cancer. BIA-ALCL is not a breast cancer. Rather, it is a rare but treatable type of lymphoma that can develop around breast implants. Due to the potential risk of BIA-ALCL associated with Allergan’s breast implants, dozens of women across the country have filed product liability claims against the manufacturer, alleging that they could have avoided a cancer diagnosis had Allergan properly researched the potential long-term side effects of its breast implants and provided adequate cancer warnings to consumers and the medical community. Additional claims are being filed by women who have not been diagnosed with cancer, but are having their implants removed for their own safety.

Allergan’s Breast Implants Recalled Due to BIA-ALCL Risk

In August 2019, the FDA announced that it was requesting a worldwide recall of all breast implants featuring the “Biocell” textured surface, “to protect individuals from the increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), associated with Allergan BIOCELL textured breast implants.” The Allergan breast implant recall came after the FDA confirmed that the company’s textured breast implants were associated with a risk of BIA-ALCL that was substantially higher than any other type of breast implants. According to the recall announcement, of the 573 cases of BIA-ALCL reported worldwide, 481 involved Allergan breast implants. Of the 13 deaths occurring in patients with BIA-ALCL where the implant manufacturer was known, 12 involved an Allergan-made breast implant.

Pursuing Compensation for BIA-ALCL Lymphoma Side Effects

The FDA warning letter says that Allergan must still complete the required studies in order to assess potential long-term outcomes in women who have already been implanted with the recalled breast implant devices. If you or someone you know has suffered a serious side effect allegedly caused by a recalled breast implant, such as breast implant-associated anaplastic large cell lymphoma, your first course of action should be to contact a knowledgeable breast implant lymphoma attorney to discuss your legal options. You may have grounds to file a breast implant BIA-ALCL lawsuit against Allergan, in order to pursue compensation for your injuries, medical expenses, pain and suffering and other damages. The amount of time you have to file a claim is limited, so don’t wait to call.