A 60-year-old woman in Pennsylvania claims that both she and her husband sustained injuries due to a faulty vaginal mesh implant she received in 2007. The product's manufacturer reportedly ignored warnings that it could cause pain and injury and put the product on the market in 2005 without approval from the Food and Drug Administration. The woman is now suing the pharmaceutical company for knowingly releasing a faulty product.
The device in question is a vaginal mesh used to treat a condition called pelvic floor prolapse, which occurs when the muscles of the pelvic floor weaken, allowing the pelvic organs to drop into the vagina. The purpose of the mesh implant is to hold the organs in place. The manufacturer claimed that it did not think it needed FDA approval to produce and sell the product because of its similarity to other vaginal mesh devices already on the market. It was only three years later, after the FDA received alerts that the product was on the market, that it gained approval. In 2012, after the device had been on the market for seven years and implanted in untold numbers of patients, the FDA ordered further testing, prompting the manufacturer to take it off the market.
However, staff members with the pharmaceutical company involved in the development and testing of the product allegedly reported as early as 2004 that the mesh could harden, fold in on itself and cause complications such as cutting into the vagina. This is reportedly what happened to the woman who filed the lawsuit in Pennsylvania. Not only did she allegedly suffer traumatic complications from the implant, but her husband reportedly received injuries during sexual intercourse as a result of wire penetration into his wife's vagina.
When asked to comment on the pending litigation, the pharmaceutical manufacturer declined, but individuals who sustain injuries from faulty medical devices have the right to seek compensation and may wish to consult an attorney.