Women suffer worldwide from pelvic organ prolapse (POP), or the dropping of pelvic organs into the lower belly, with over 3 million women affected in the United States alone. When the muscles that hold women’s pelvic organs in place are weakened or stretched due to vaginal childbirth or surgery, their risk of POP increases. POP can involve the dropping of the intestines, bowel, uterus, cervix, and rectum, but most often occurs with the bladder.
POP involves a variety of major health issues and side effects, including painful pressure in the vagina, urinary incontinence, chronic constipation, and painful intercourse, among other varying symptoms. Many doctors prescribe using a transvaginal mesh to repair the weakened or damaged pelvic tissue.
Transvaginal mesh is a surgical mesh made from either synthetic materials or animal tissue, designed to reinforce weakened vaginal walls and repair POP. The synthetic version is intended to permanently treat the affected area, while the animal tissue mesh is temporary and will eventually be absorbed into the body. Both types of transvaginal mesh offer benefits to women suffering from different levels and types of POP, but they also can carry serious safety risks.
There are currently five manufacturers dominating the market for transvaginal mesh devices, including Johnson & Johnson, Bard Medical, and Boston Scientific. For years, there has been widespread speculation in the healthcare field about the possible negative effects of transvaginal mesh, but there are yet to be any measures taken to prevent them from entering the market.
With nearly 500,000 transvaginal mesh surgeries occurring each year, the FDA has seen a significant increase in reported adverse effects associated with the product. Not all transvaginal mesh products are safe or reliable for use against POP, even though they have yet to be removed from the market.
Complications and side effects of a transvaginal mesh implant can include:
These are only complications of procedures that were done correctly and with the appropriate devices. They do not include severe health problems that have recently been associated with counterfeit transvaginal mesh surgeries.
In light of recent allegations against the medical device manufacturer Boston Scientific, more and more women are nervous about the potential dangers associated with a transvaginal mesh implant. The FDA is currently investigating Boston Scientific after it was accused of smuggling counterfeit plastic resin from China for their transvaginal meshes. Women have suffered bleeding, infections, urinary issues, and other painful side effects after a Boston Scientific transvaginal mesh was implanted, and these women are taking the company to court.
The FDA has recently released an announcement that they’ve increased the requirements for transvaginal mesh to be approved, hoping to prevent catastrophes like the current Boston Scientific scandal in the future. Tens of thousands of lawsuits are pending against transvaginal mesh distributors – not only limited to Boston Scientific. After growing concern from the FDA, Johnson & Johnson have ceased to manufacture or distribute their transvaginal mesh products, although they haven’t recalled their existing products.
Thousands of women have been gravely injured or negatively effected by transvaginal mesh implantations and are seeking justice for their pain and suffering. If you or someone you know has had transvaginal mesh or pelvic mesh placement and have been caused to suffer serious negative side effects, there is a time limit on how long you have to pursue your case called the Statute of Limitations. The Statute of Limitations in Massachusetts is three years, but is different in each state. Therefore, if you or someone you know has suffered the serious negative side effects caused by transvaginal mesh or pelvic mesh, have them contact an attorney at Sweeney Merrigan Law for a case evaluation before it’s too late.