By age 80, more than one in every 10 women will have undergone surgery for stress urinary incontinence and pelvic organ prolapse, according to Harvard Medical School’s Family Health Guide. Since being introduced in 1996, transvaginal mesh has been surgically implanted in hundreds of thousands of women to treat these conditions. Because of the increasing rate of diagnosis, there’s even a new surgical specialty of urogynecology that has arisen to correct prolapse conditions. Today, many primary care physicians and gynecologists routinely screen patients for symptoms and may recommend transvaginal mesh surgery to patients. With a growing number of problems and failures associated with the mesh however, women should be extremely cautious and consider other treatments before pelvic mesh or bladder sling surgery.
More Harm Than Good?
The synthetic surgical mesh products designed to fix stress urinary incontinence and pelvic organ prolapse are actually associated with a high failure rate. Many women have reported serious complications including erosion of the device through the vaginal wall, which can lead to painful sexual intercourse, inability to have sexual intercourse, and severe pain. Erosion of the transvaginal mesh can require revision surgeries, although there’s never a guarantee that such a surgery will be successful. In some cases, the mesh becomes so intertwined with tissue and organs that it can never be fully removed safely.
New England Journal of Medicine Study
A May 2011 study published in the New England Journal of Medicine found that transvaginal mesh products may be no more effective in treating stress urinary incontinence and pelvic organ prolapse than traditional forms of treatment that involve stitching the connective tissue of the vaginal wall together (colporrhaphy). In July 2011, the US Food and Drug Administration (FDA) issued a nationwide alert to women and medical professionals, acknowledging the findings of the study and warning of the potentially dangerous side effects of vaginal mesh products. The FDA no longer believes transvaginal mesh is the safest treatment for pelvic organ prolapse and recommends against of its use as a first response.
Vaginal Mesh Complaints
When the FDA issued its July 2011 warning, it announced the agency had received nearly 4,000 complaints of serious injuries in patients. In addition to the mesh eroding into the vaginal walls, women who have undergone mesh surgery reported many other complications, including:
- Severe pelvic pain
- Pain during sexual intercourse
- Perforation of bladder, intestines, urethra, bowel
- Vaginal scarring
- Vaginal bleeding / hemorrhaging
- Nerve damage
- Urinary tract infection (UTI).
Erosion of vaginal mesh puts women at risk for potentially fatal complications such as infection, nerve damage, hemorrhaging, and perforation of other organs. Erosion is sometimes also called exposure, extrusion or protrusion. When there is significant risk of further damage occurring, revision surgery may be necessary. Many women who suffer complications are also diagnosed with depression.
Multiple Revision Surgeries Are Often Necessary
Surgeries to revise a failed transvaginal mesh can be complicated procedures. Over time, the mesh fuses with the soft tissue, essentially becoming embedded into pelvic organs, the uterus, or the bladder. In many cases, multiple revision surgeries are required, with relative success. The severity of the complications of the initial surgery determines the extent of the revision surgery. In one case, a 47-year-old South Dakota woman had a Prolift pelvic mesh implanted in 2005 and subsequently underwent 18 revision surgeries. At trial in 2013, she testified that the vaginal mesh implant has rendered her unable to work, have sexual intercourse with her husband, or even sit comfortably for more than 20 minutes at a time. In that case, a $3.35 million verdict was awarded to the plaintiff, who is now disabled.
Don’t Wait To Contact a Lawyer
It is not too late to file a suit against Johnson & Johnson, Bard, AMS, Boston Scientific and other mesh manufacturers. However, if you have been harmed by mesh, you have a limited period of time to pursue a lawsuit. The attorneys at Estey & Bomberger are here to help you. For a free consultation, call us today. Under our contingency fee agreement, there are no fees unless we win your case.
Medical device cases are complex and medical device manufacturers are willing to invest millions to keep their products on the market. Don’t trust your case to just any law firm. Choose a firm that has the experience, knowledge and skills to The attorneys at Estey Bomberger work with some of the best experts in the country, including psychologists, medical professionals, and medical device experts to maximize the value of your case.