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Two women have filed a product liability lawsuit that alleges they experienced a variety of health problems, commonly referred to as “breast implant illness”, after Mentor MemoryGel silicone implants were placed in their bodies.
The complaint (PDF) was filed by Amber Brooks, of Missouri, and Jamie Gale, of Kansas, in the U.S. District Court for the District of Kansas, seeking damages from Mentor Worldwide, LLC, for selling the silicone breast implants without warning about potential side effects and adverse reactions experienced by women.
Brooks indicates that she received Mentor MemoryGel Breast Implants in March 2016, and Gale received her implants in September 2009. In each case, the women indicate that they began suffering a large number of health problems from the breast implants, including muscle pain, joint pain, fatigue, weakness, weight loss, recurrent vaginal infections, rashes, lesions, bumps, cognitive problems, headaches, loss of breast sensation, inflammation, gastrointestinal issues and other health problems.
Similar symptoms have been reported by a growing number of women in recent years after breast augmentation or reconstructive surgery, and the condition is increasingly referred to as “breast implant illness”.
As a result of the problems, Brooks indicates that she had her breast implants removed in February 2017, less than a year they were put in place. Gale had her implants removed in July 2017. In both cases, the side effects disappeared after removal of the breast implants.
The lawsuit claims Mentor has known about the health problems linked to silicone breast implants for years, yet failed to warn the medical community or patients, actively concealing the risks women may face, and failing to properly conduct a number of post-approval studies required by the FDA.
“(A) Mentor chemist of 15 years reported to the FDA that Mentor’s implants are more likely to break than the company reported. It has also been reported that the silicone is more likely to leak, even when the implants are intact, and that the materials used in the implants are more dangerous than reported,” the lawsuit states. “Mentor knew of these risks associated with its implants, but covered them up by terminating studies, sponsoring only self-serving research it could control, and by misrepresenting the risks to the users, physicians, and regulatory agencies.”
Brooks and Gale present claims of negligence, failure to warn and manufacturing defect.
Breast Implant Side Effects
A growing number of doctors are recognizing symptoms and problems similar to those experienced by Brooks and Gale as “breast implant illness,” commonly involving chronic side effects, such as fatigue, cognitive problems, muscle and joint pain, hair loss, infections, gastrointestinal problems, rashes and thyroid issues. In many cases, the problems have led women to have their breast implants removed, and concerns about the risk have become a factor many are questioning whether to undergo breast enhancement or reconstruction surgery.
Breast implants have been placed in the bodies of more than 10 million women across the globe over the last decade, and the FDA’s own data acknowledges that as many as 20% these women will get the breast implants removed less than 10 years later, often to complications like rupturing, scar tissue problems and deflation.
In addition to breast implant illness, new concerns have emerged in recent years about growing reports involving women diagnosed with a rare cancer in the tissue surrounding the device, which is known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
According to a report published in December 2018, as part of an investigation into medical devices known as the “Implant Files”, investigators found that regulators have largely allowed manufacturers to hide these potential side effects of breast implants from the public in prior years.
Before 2016, there were fewer than 200 suspected breast implant injuries reported every year, according to the report. However, in 2017, the FDA deployed more stringent medical device reporting rules, which no longer allowed manufacturers to report “routine events” without making them public. In 2017, the number of reports jumped to 4,567, and there were more than 8,200 reports in the first half of 2018 alone.
The report indicates that regulators worldwide allow breast implant manufacturers to get away with violating reporting rules.