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The FDA Requests Allergan Voluntarily Recall

On Behalf of | Feb 10, 2020 | FDA Alerts

In August 2019, the Food and Drug Administration (FDA) requested that Allergan recall its BIOCELL textured breast implants and tissue expanders due to an increased risk of cancer among implant patients. Here, the product and medical device liability litigation attorneys at Peter Angelos Law discuss the connection between Allergan’s BIOCELL products and the increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

Medical Device Reports (MDRs) Have Reported Worldwide Cases of BIA-ALCL

The BIOCELL textured breast implants use a unique textured surface that is only used by Allergan. The recalled products include the Natrelle Saline Filled Breast Implants, Natrelle Silicone-Filled Textured Breast Implants and Natrelle 410 Highly Cohesive Anatomically Shaped Silicone Filled Breast Implants. The FDA conducted a study examining worldwide cases of Allergan’s implants and the potential link to BIA-ALCL. Of the 573 cases of BIA-ALCL, 481 were attributed to Allergan implants.

In a study by the American Society of Plastic Surgeons, it was found that textured implants with a higher surface area lead to an increased risk of BIA-ALCL diagnosis. However, Allergan’s BIOCELL implants were found to be 14.11 times more likely to lead to a BIA-ALCL diagnosis, resulting in Allergan’s worldwide voluntary recall.

Affected Women Have Filed Class Action Complaints in Response

After the July 24, 2019 recall of BIOCELL implants by Allergan, various women filed class action complaints in response. While it is noted that individuals should not have their implants removed without careful consideration and monitoring of symptoms, affected and high-risk BIA-ALCL patients have found themselves with extraordinary medical bills along with both physical and emotional pain and suffering.

It is important to note that BIA-ALCL is not breast cancer, but rather a form of Non-Hodgkin’s Lymphoma that primarily affects the immune system. Common symptoms to monitor for the potential of BIA-ALCL include enlargement or asymmetry of the affected area, hardening of the breast, or a large fluid collection that typically occurs after a year of the original implantation. In January 2018, a Dutch study was conducted examining BIA-ALCL in women with breast implants, and the risk was found to be one in 35,000 for women at the age of 50, one in 12,000 at the age of 70, and one in 7,000 by the age of 75.

Find a Health Advocate at the Team of Baltimore Attorneys at Peter Angelos Law

It is the responsibility of organizations such as the FDA, as well as international corporations like Allergan, to create and monitor products with the public’s health and best interest at heart. When illness and possible death results from these products, individuals should be entitled to compensation and representation for their emotional, financial and physical hardships. At Peter Angelos Law, our team of product and medical device liability attorneys have proven their abilities in litigating both personal injury and class action cases. To learn more about your legal rights, schedule a free consultation with the Law Offices of Peter Angelos Law today.