Breast Implant Lymphoma Risk From Allergan Biocell Known By Manufacturer Since 2011: Lawsuit
A group of women have anonymously filed a class action lawsuit against Allergan over its recalled Biocell breast implants and tissue expanders, indicating that they have been exposed to a higher risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) due to the textured design of the products.
The complaint (PDF) was filed earlier this month in the U.S. District Court for the Central District of California, involving claims on behalf of 14 women identified only by their initials, who each indicate that they received recalled Allergan breast implants that used Biocell technology, which has been found cause the development of a rare form of lymphoma in the tissue surrounding the implant.
The lawsuit alleges that Allergan should be required to pay for all of the medical costs associated with removing and replacing the breast implants, and should provide medical monitoring for all women who received the recalled devices.
Allergan was forced to issue a worldwide worldwide breast implant recall for products featuring the Biocell design, after the FDA determined earlier this year that the product was linked to nearly all reported cases of BIA-ALCL, which is a form of non-Hodgkins lymphoma.
Although Allergan allegedly knew about the breast implant lymphoma risk for years, the lawsuit notes that the only reason the implants are off the market is because the FDA forced the issue.
“Although it knew of the increased risks of BIA-ALCL as early as 2011, Allergan failed to warn women considering their implants,” the lawsuit states. “Although Allergan has now issued a recall pursuant to FDA’s directive, it refuses to take full responsibility and refuses to cover the significant costs associated with removal and replacement of the defective devices and medical monitoring, among other damages.”
The case joins dozens of similar class action lawsuits filed in recent months, as well as individual product liability complaints brought by women diagnosed with the breast implant lymphoma, which have been centralized as part of a multidistrict litigation (MDL) in the federal court system.
Allergan Biocell Breast Implant Problems
The FDA indicates there are at least 573 known cases of BIA-ALCL diagnosed worldwide, including 33 deaths. Of those, 481 have been linked to Biocell breast implant designs. Allergan implants were also linked to 12 of the 13 deaths where the manufacturer of the breast implant was known.
In June 2017, a study published in the medical journal Plastic and Reconstructive Surgery suggested that certain textured breast implants may increase the risk of anaplastic large cell lymphoma anywhere from 10 to 14 times, when compared to smooth breast implants.
Another study, published in October 2017, warned that many breast implant cancer cases worldwide have likely not been reported, and noted doctors and patients may not be aware of BIA-ALCL.
The FDA is not recommending women have the breast implants removed if they are showing no symptoms. Instead, the regulators recommend recipients of these implants become familiar with the symptoms of BIA-ALCL, including persistent swelling or pain near the implant, and talk to their health care provider for further information. Those with BIA-ALCL should undergo breast implant removal and removal of the surrounding scar capsule.
The agency also recommends those who receive breast implants keep a record of the device manufacturer, unique device identifier and implant model name, which may have been provided on a patient device card from the surgeon.
Those with questions regarding the safety communication can email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or by calling 800-638-2041 or 301-796-7100.
Cases of BIA-ALCL or other complications should be reported to the FDA MedWatch Adverse Event Reporting Program.