In March 2019, dozens of women appeared before a U.S. Food and Drug Administration (FDA) advisory panel to give their accounts of how breast implants had caused them to suffer illness. Eighteen months later, on September 28, 2020, the FDA issued its strongest warning for all breast implant products.
In this action, the FDA put forth its recommendations about labeling information for both saline and silicone gel-filled implants. The final guidance document, Breast Implants – Certain Labeling Recommendations to Improve Patient Communication, outlines specifications regarding both content and format the agency hopes will help ensure that potential breast implant recipients understand not just the benefits, but also the risks of these devices. Specifically, the guidance issues recommendations for:
- Boxed warnings
- Patient decision checklists
- Descriptions of the device and materials, such as any heavy metals or chemicals that the implants might contain or release
- Recommendations for silicone gel-filled implant rupture screening
- Patient device card
The Washington Post reported about the two-day hearing that occurred last March. Women offered up emotional accounts of how they were not adequately warned of the risks these implants posed and how they suffered medical complications from the devices.
Breast Implant-Associated Anaplastic Large Cell Lymphoma
One complication, in particular, has been getting much media exposure lately. Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare type of non-Hodgkin’s lymphoma. Typically, it appears in the scar tissue and fluid around the breast implant. Sometimes, however, the cancer spreads elsewhere throughout the patient.
Despite its rarity, BIA-ALCL is considered serious and can prove fatal. These outcomes increase in likelihood when the disease is not diagnosed early or is not treated. Treatment typically involves removing the scar tissue and the implant. Sometimes, treatment requires chemotherapy and/or radiation therapy.
According to an August 2020 update from the FDA, the agency has documented 733 unique cases of BIA-ALCL. Thirty-six deaths have resulted from the disease.
The FDA has also been documenting manufacturer information for each BIA-ALCL case and death. Of the current, known cases:
- 620 occurred in patients with Allergan breast implants
- 47 cases manifested in patients with implants from unknown manufacturers
- 496 cases stemmed from textured implants
- 209 cases did not mention the implant surface
Of the 36 total global deaths, 15 patients had Allergan breast implants when they received their BIA-ALCL diagnosis. Sixteen of the cases ending in death reported textured implants.
Lawsuits Related to BIA-ALCL
Hundreds of women have suffered grave illness from their breast implants, particularly those with textured surfaces. Many BIA-ALCL patients now seek compensation from the implant manufacturers and have filed lawsuits to recover their damages.
Typical demands in these lawsuits include Allergan (or another device manufacturer) covering the cost of removing and perhaps replacing plaintiffs’ breast implants. Quite likely, many plaintiffs will seek additional compensation for the pain and suffering linked with these implants, as well as the emotional stress and anxiety they endured while facing the risk of developing cancer.