Mentor Breast Implant Lawsuit Filed Over Mold Infection, Bio-Toxin Disease

Complications from leaking breast implants allegedly caused a Georgia woman to develop a mold infection, which led to bio-toxin disease, according to a product liability lawsuit filed against Johnson & Johnson and it’s Mentor Corporation subsidiary. 

The complaint (PDF) was filed this month by Melissa Shirley in the U.S. District Court for the Northern District of Georgia, alleging that her Mentor saline breast implants were defectively designed and unreasonably dangerous.

Shirley underwent breast augmentation surgery in June 2003, at which time saline breast implants manfufactured and sold by Mentor were implanted.

More than ten years later, in 2015, Shirley indicates that she was diagnosed with bio-toxin disease, which is often caused by exposure to mold and results in severe and chronic inflammation and a number of resulting health problems. According to the lawsuit, Shirley developed this condition due to problems with the Mentor breast implants, which manifested as enlarged lymph nodes, sternal pain and mastodynia.

On May 14, 2015, Shirley had the breast implants surgically removed, at which time it was determined that the breast implants were leaking.

“Plaintiff, her prescribing physicians, and her health care providers neither knew nor had reason to know at the time of Plaintiff’s use of The Implants of the aforementioned defects,” the lawsuit states. “Ordinary consumers would not have recognized the potential risks for which Defendants failed to include the appropriate warnings.”

Shirley presents claims for product liability, negligence, strict liability, breach of express warranty, breach of implied warranty, and negligent misrepresentation.

Breast Implant Health Risks

The complaint comes amid increasing concerns about the risk of problems with breast implants used during augmentation and reconstructive surgery in recent years.

In March 2017, the FDA issued a breast implant cancer warning, indicating that it was aware of at least 359 medical device reports involving women diagnosed with a rare form of non-Hodgkins lymphoma, known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The illness has been linked to at least nine deaths.

The agency indicated at the time that the lymphoma cases appeared to be more common among breast implants with textured surfaces, as opposed to smooth breast implants, but a definitive connection was not able to be made.

Australia’s Therapeutic Goods Administration (TGA) launched an effort monitor the association between breast implants and anaplastic large cell lymphoma, more than doubling the recognized number of cases identified among Australian patients between September 2016 and April 2017.

Researchers from the TGA published a study in May indicating that side effects of textured breast implants may be linked to a 14 times higher risk of ALCL in some cases.

The TGA has estimated that the breast implant lymphoma risk may be between 1-in-1,000 and 1-in-10,000, with most cases occurring between 3 and 14 years after implant, but the median being 8 years and some cases diagnosed as much as 37 years after breast surgery,

Due to the potential lymphoma risk with breast implants, regulators have made efforts to increase awareness among health care providers about cases of the rare cancer linked to textured breast implants, indicating that they should discuss the benefits and side effects of the implants with their patients.

The FDA has also recommended that doctors consider the possibility that a breast implant recipient is suffering from anaplastic large cell lymphoma (ALCL) when they present with late, onset, persistent peri-implant seroma.

In the United States, a growing number of women are now considering potential breast implant lawsuits against the manufacturers of the products, alleging that inadequate warnings have been provided for consumers and the medical community about the potential risk of cancer and other problems.

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