In the last two decades, more than 150 surgical mesh devices have been introduced to the market: 83 for stress urinary incontinence, 63 for pelvic organ prolapse, and 22 for both conditions. Sales reps from medical device manufacturers travelled the country in an effort to convince doctors that these synthetic mesh devices were the best option for treating pelvic organ prolapse and stress urinary incontinence. It was not until 2008 that adverse health complications were noted with mesh devices. Only in 2010 did in-depth studies on transvaginal mesh begin. By 2011, the mesh itself was labeled a greater risk than the surgery.
Synthetic mesh is made from flexible plastic material that looks similar to a window screen. It is usually implanted through the vagina and holds the organs in place and bind with pelvic tissue. Over time this mesh can erode and crumble, creating sharp edges that can perforate organs and cause infection, intense pain, and other serious injuries. At least two deaths have been reported related to bowel perforation resulting from pelvic organ prolapse. Perforation can occur during the insertion of the transvaginal mesh, or as the mesh erodes over time. Initial symptoms of perforation may include:
- Abdominal pain
- High fever.
In July 2011, the Food and Drug Administration (FDA) issued a safety alert warning medical professionals that complications of transvaginal mesh surgery could include perforation of the bladder, bowel or blood vessels. The FDA found that there was no evidence that the mesh devices had greater benefit than other available treatment options. Despite this warning, surgeons continue to perform mesh procedures at alarming rates, sometimes without warning women of the risk of perforation and other serious complications.
According to an article published in May 2011 in the New England Journal of Medicine, someone with transvaginal mesh has a seven percent higher risk of bladder perforation than traditional treatment. The FDA is considering changing the risk classification of using mesh to treat transvaginal pelvic organ prolapse from Class II to Class III, as well as expanding monitoring of how well mesh devices perform once they are on the market (have been surgically implanted).
If not treated, organ perforation can lead to sepsis, and could be fatal. In one reported case, a 61-year-old woman died from perforation injuries 10 days following having a Gynemesh device implanted. According to the FDA, between 2008 and 2010, seven deaths were reported.
Vaginal mesh perforation is a painful condition with long-lasting effects, not just on victims, but also on loved ones. The impact of a failed mesh surgery is not just physical, but emotional and financial as well. If a loved one has died as a result of a mesh surgery complication, surviving family members may also be entitled to compensation in a wrongful death claim. At Estey Bomberger, our experienced defective product attorneys are here to help you recover the maximum compensation you deserve and hold negligent medical device manufacturers accountable. For more information, contact us today for a fee consultation with no obligation.