In 2010 alone, an estimated 75,000 women received transvaginal mesh implants to treat pelvic organ prolapse (POP), and an additional 200,000 women underwent vaginal sling implant surgeries for stress urinary incontinence (SUI). As a result, a growing number of women are reporting serious adverse effects related to the vaginal mesh failure. One of the most common reported causes of mesh-related complication is the contraction of the surgical mesh. The FDA has identified that serious complications for patients who receive vaginal mesh implants are not rare, and can result in:
- Vaginal shrinkage/scarring
- Recurrent prolapse/incontinence
- Urinary problems
What is Mesh Contraction?
When a patient undergoes a POP or SUI correction surgery using a surgical mesh, a device made of polypropylene is implanted in the pelvic region to support the prolapsed organs or strengthen the muscles around the urethra. Constructed out of surgical mesh, and designed to be permanent, overtime, the vaginal tissue will grow on top of the device. But in some cases, the polypropylene used in vaginal mesh devices can shrink, causing substantial morbidity as it contracts around the vaginal tissue. To reverse the side effects of mesh contraction, patients frequently require surgery (sometimes multiple surgeries) to extract the device. Symptoms of mesh contraction include:
- Persistent bleeding
- Pelvic or vaginal pain
- Excessive discharge
- Pain during sex
- Sense of something protruding from the vagina
Past FDA Notices
Problems with transvaginal mesh devices were evident since 1998, with Boston Scientific’s ProteGen, which the company eventually recalled after facing more than 700 lawsuits that were settled in 2003 for an undisclosed amount. On October 20, 2008, the FDA noted that transvaginal mesh devices could potentially cause serious side effects but that the cases were rare. In 2011, the FDA released several statements, first noting that the risks of mesh-related complications is not rare, followed by a reclassification of the devices from moderate-risk to high-risk. The FDA also noted that there was no evidence to suggest that a transvaginal mesh implant had better symptomatic results than non-mesh surgeries.
Safety Testing and Manufacturer Liability
This dangerous device received FDA clearance via the 510(k) process that enabled the manufactures to sell and market the vaginal slings without previously conducting clinical trials. As a result of the thousands of injury reports and the dearth of human clinical studies, the FDA ordered 33 vaginal mesh device manufacturers to conduct three-year studies to assess the risks and health complications associated with the product. More than 650 patients have filed lawsuits against manufacturers like Johnson & Johnson, C.R. Bard, American Medical Systems, and Boston Scientific.
Consult an Experienced Transvaginal Mesh Injury Lawyer
Patients who have suffered serious complications due to a defective transvaginal mesh device may be capable of recovering compensation for the damages incurred. The skilled vaginal sling injury attorneys at Estey Bomberger can ensure you recover maximum compensation for your injuries. Our attorneys are currently offering free case evaluations to women who have received a transvaginal mesh implant. To determine your rights and legal options, please contact us today for a free consultation with a knowledgeable surgical mesh implant lawyer.