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A Mississippi woman indicates that she developed a rare form of lymphoma from McGhan Breast Implants, indicating that the textured design resulted in the development of cancer in the tissue surrounding the implant.
Jaime Hallman Guttierrez filed the complaint (PDF) in the U.S. District Court for the Southern District of Mississippi on January 15, indicating that the design of McGhan Breast Implants resulted in a diagnosis of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), which has since been linked to the use of textured breast augmentation implants.
Guittierrez received the breast implants in August 2003, indicating they were removed last month, following the discovery of cancer.
The lawsuit, which names Allergan, Inc. and its subsidiaries as defendants, noting that the company purchased McGhan and it’s parent company Inamed in 2006. According to allegations raised in the complaint, neither company adequately warned the medical community or patients about the potential risks of developing BIA-ALCL.
Allergan was forced to issue a worldwide breast implant recall last year for products featuring its macrotextured Biocell design, which some say was a successor to the McGhan design. The action was taken after the FDA determined last year that the products were 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.
The lawsuit further indicates Allergan delayed reporting incidents of BIA-ALCL when it learned of them from adverse event reports and postmarket approval studies.
“Despite having knowledge and possession of evidence showing that the use of the McGhan Breast Implants was dangerous and likely to place consumers’ health at serious risk, as will be detailed further below, Defendants refused or recklessly failed to identify, disclose and warn of the health hazards and risks associated with the product, and about all adverse events which were known to Defendants,” the lawsuit states. “Instead, Defendants marketed, advertised and promoted the product while at the same time consciously refusing and/or recklessly failing to monitor, warn, or otherwise ensure the safety and efficacy for users of the McGhan Breast Implants.”
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.