Allergan wants to track breast implants—and they have a really good reason.
Responding to a request from the U.S. Food and Drug Administration, Allergan Aesthetics, an AbbVie company, issued a recall of its BIOCELL breast implants and tissue expanders in the summer of 2019. Studies have linked these Allergan medical devices with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)—a potentially fatal cancer.
An increasing awareness of the health risks has bubbled up to the public, despite manufacturers’ attempts to cloak the problems, according to an investigation conducted by Fortune magazine. Further exacerbating these risks, Allergan has not done a good job of tracking its medical devices.
To date, the company admits to lacking tracking information for around 52,000 BIOCELL breast implants.
To try to identify the recipients, Allergan is asking patients to visit BIOCELLinformation.com if they:
- Know they have an Allergan implant and have not participated in device tracking; or
- Need to update their information
is strongly advising patients to register for device tracking.
Recipients Must Learn About the Health Risks of BIOCELL Implants and Tissue Expanders
Driving the significance of device tracking is Allergan’s need to notify all its implant and tissue expander recipients that the devices have been recalled due to the risks of BIA-ALCL. The FDA urged the manufacturer to beef up its outreach efforts to patients. Hence, the announcement of a multi-channel campaign aimed at contacting patients who may not have heard about the recall and encouraging device recipients to register in the company’s tracking system.
“We are determined to make sure every woman has the information they need related to the BIOCELL® voluntary recall and we will continue to encourage women with breast implants to determine their implant type and opt-in to our device tracking system,” said Carrie Strom, Senior Vice President AbbVie and President Global Allergan Aesthetics, in a company-issued press release.
“Patient education is a priority.”
Storm added that Allergan has partnered with the American Society of Plastic Surgeons (ASPS) and the American Society of Aesthetic Plastic Surgery (ASAPS) on “major initiatives to raise awareness regarding the importance of breast implant tracking.”
More on the BIOCELL Recall
Allergan issued its voluntary recall of BIOCELL products at the FDA’s request. New Medical Device Reports (MDRs) revealed cases of BIA-ALCL and BIA-ALCL-related deaths linked to the textured implants and tissue expanders. The FDA published the results of its analysis, which showed that the risk of BIA-ALCL with the company’s BIOCELL textured implants was six times greater than the risk of textured implants from other manufacturer’s textured implants.
The agency’s statement on the topic concluded that “…continued distribution of Allergan’s BIOCELL textured breast implants would likely cause serious, adverse health consequences and potentially death from BIA-ALCL.”
BIA-ALCL is a type of non-Hodgkin’s lymphoma and is found near the implant in fluid and scar tissue. The cancer can also spread throughout the body. A diagnosis of this lymphoma is serious and potentially fatal, however removing the implant and its surrounding scar tissue can yield positive results. In some cases, chemotherapy and/or radiation therapy may be required.
Recipients Are Filing Lawsuits
BIA-ALCL is considered a rare form of cancer. However, 80 percent of known cases are connected to Allergan breast implants, according to the FDA. This is alarming news for recipients of the medical devices, and the manufacturer’s failure to warn recipients of the risks has prompted several to file lawsuits against the company.
Several of the plaintiffs have not been diagnosed with BIA-ALCL, but they are suing Allergan for the increased risk of developing the cancer that they now face. Damages will likely include the cost of removing the implants, disfigurement, and emotional distress.