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A federal judge has cleared the way for a breast implant lawsuit against Mentor to proceed, but dismissed most of the claims raised in the complaint.
In an order (PDF) issued earlier this month, U.S. District Judge James Moody, Jr. indicated that claims involving manufacturing negligence over a ruptured breast implant may proceed, but dismissed other claims after finding that they are preempted by federal law.
The complaint was brought by Colleen Rowe, who underwent breast augmentation surgery in April 2015, at which time Mentor MemoryGel silicone implants were placed in her body. However, by November of that year it became apparent that the left breast implant had ruptured, requiring her to undergo a second surgery to replace the implant. Rowe continued to suffer pain, discomfort and swelling in her left side, and her doctors have recommended a third surgery, at which time she intends to have the implants removed.
The original Mentor breast implant lawsuit presented claims for negligence, strict liability, and breach of implied warranty. However, Mentor sought to dismiss the case, arguing that the claims are preempted by federal law. However, Judge Moody only dismissed the charges of strict liability and breach of implied warranty, allowing the case to move forward on the negligence claim; specifically focusing on claims of manufacturing defect.
The order requires Rowe to file an amended complaint.
Breast Implant Problems
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.
More recently, new concerns have emerged about a link between certain breast implants and lymphoma, which may develop in the tissue surrounding the implant. The problems appear to be linked to certain textured implants, which may increase the risk of a rare type of cancer now known as breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL).
Product liability lawyers in the U.S. are reviewing potential textured breast implant lawsuits against Mentor and other companies, for women diagnosed with ALCL.