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A U.S. District Judge has cleared the way for a Mentor silicon breast implant lawsuit to proceed, indicating that that the claims over health complications caused by a ruptured implant are not preempted by federal law.
In a memorandum opinion and order (PDF) on January 11, U.S. District Judge Gary Feinerman denied in part and granted in part a motion to dismiss filed by Mentor World Wide. As a result the lawsuit can move forward, but without some of the original claims.
Catherine Gravitt and her husband, Travis, filed the original complaint (PDF) in the Circuit Court of Cook County, Illinois in June 2017, and the case was later removed to the U.S. District Court for the Northern District of Illinois by Mentor.
According to allegations raised in the product liability lawsuit, Gravitt was implanted with textured Mentor MemoryGel Silicone Breast Implants in 2010. However, she began to suffer muscle soreness, fatigue, abnormal thyroid levels, drowsiness, anxiety, and depression.
As a result of the breast implant complications, Gravitt underwent a number of procedures to alleviate the symptoms, and later gave birth to a son with severe heart defects, and a daughter with severe bladder and kidney defects, as well as additional physical and mental health problems.
It was not until 2016, after a lump developed in her breast, that Gravitt’s doctor discovered that the Mentor breast implant ruptured and had been leaking. The lawsuit blames Gravitt’s health problems and her children’s birth defects on the allegedly toxic materials leaked from the breast implant into her body.
She underwent revision surgery in October 2016, and several lymph nodes were removed as well, due to silicone contamination, the lawsuit indicates.
Mentor tried to have the case dismissed, arguing that the claims were preempted by the fact that the breast implant was approved for use by the FDA. However, Judge Feinerman noted that Gravitt’s original claim noted that Mentor had failed to disclose to the FDA certain details in its original studies regarding health complications suffered by women during clinical trials.
“Plaintiffs may proceed with Catherine’s claim that Mentor violated its state tort law duties by concealing that the risk of gel bleed associated with MemoryGel was higher than the company publicly revealed, and with Travis’s associated consortium claim,” the judge ruled. “Plaintiffs’ other claims are dismissed, though the dismissal is without prejudice.”
Judge Feinerman indicated that the plaintiffs have until February 1 to file an amended complaint, which could reinstate some of the dismissed claims.
The case is one of several lawsuits filed against Mentor over silicone breast implant problems.
Silicone Breast Implant Concerns
Silicone breast implants were introduced in the 1960s, and were removed from the market after safety concerns were raised with the FDA in 1992, amid reports of breast implant ruptures. A moratorium was placed on the silicon implants until findings concerning their long-term safety could be determined.
The implants were reintroduced to the market in 2006, after no definitive links to health side effects or disease were found. The FDA ruled against a second silicone breast implant recall in 2011, and called for improved surveillance, demanding manufacturers perform long term follow-up studies.
Researchers have struggled to determine the health risks linked to silicone breast implants. In November 2015, a study in the Annals of Internal Medicine found an association between silicone breast implants and an increased risk of lung cancer.
However, the same study also linked silicone breast implants to a decreased risk of breast cancer and endometrial cancers.
In 2012, UK health officials said the silicone gel in Poly Implant Porthese (PIP) breast implants was not toxic to women. The report revealed the implants had a tendency to rupture in on-third of women, but the industrial-grade silicone gel was nontoxic.
In 2011, the consumer watchdog group Public Citizen warned that the FDA did not adequately alert women to silicone breast implant risks. The group advised women against getting the silicon implants.
Breast Implants Lymphoma
Last year, the FDA issued warnings about breast implant lymphoma rates, indicating that the agency was aware of at least 359 medical device reports worldwide involving women diagnosed with the rare form of non-Hodgkins lymphoma, including at least nine deaths.
In June, another 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.
In October 2017, a study published in the medical journal JAMA Surgery warned that many breast implant cancer cases worldwide have likely not been reported, and noted that doctors and patients may not be aware of breast anaplastic large-cell lymphoma (ALCL). As more information becomes public about the breast implant cancer cases, experts have warned that the number of cases reported will likely increase significantly.
As regulators and researchers worldwide continue to evaluate the specific cause of the breast implant lymphoma problems, many women are raising serious questions about why certain products appear to be more likely to be associated with the development of cancer, and how manufacturers failed to address potential design defects earlier.
Product liability lawyers in the U.S. are reviewing potential textured breast implant lawsuits for women diagnosed with anaplastic large cell lymphoma (ALCL), which develops in the tissue surrounding the breast.