What is a transvaginal mesh implant?
Also called a vaginal sling, patch, and tape, a transvaginal mesh implant is a surgical mesh device used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in women. Several medical device manufacturers such as C.R. Bard, Johnson & Johnson, American Medical Systems, and Boston Scientific manufactures and sells surgical mesh products designed for transvaginal implantation. In recent months, the FDA and thousands of patients have been questioning the safety of these products; the FDA even issued a warning to patients and healthcare providers regarding the potential risks of this product.
Why are vaginal mesh devices dangerous?
More than 4,000 patients filed injury reports to the FDA during 2005 and 2010. The FDA estimates that failure rates for vaginal mesh devices may be as high as 10 percent. Device failure can result in serious complications such as:
- Vaginal scarring
- Recurrence of condition
- Mesh erosion through the vaginal epithelium
- Urinary problems
- Pain during sexual intercourse
Why did the FDA approve a product with such a high failure rate?
The first transvaginal mesh device was approved in 1996 under the FDA code 510(k), a clearance process that does not require the manufacturer to conduct thorough testing of the product. Although the device was recalled after three years, due to overwhelming numbers of injury reports, dozens of medical device manufacturers have been able to receive clearance for products similar to the recalled mesh.
I have a vaginal sling implant for my POP or SUI, what should I do?
If you are satisfied with your treatment, it is not necessary for you to take further action. However, it is important for all patients to go through annual and other routine check ups to ensure complications do not develop in the future.
What are the symptoms I should watch out for?
The most common symptom for vaginal mesh failure is pelvic or vaginal pain. Sometimes the pain may only occur during sexual intercourse. Other symptoms include: bleeding, persistent discharge, and a return of the treated condition (POP or SUI).
What are my options in the event of a vaginal mesh sling failure?
If you have suffered severe health complications as a result of a defective vaginal patch, patients may be capable of filing a product liability lawsuit against the medical device manufacturers. Presently, several companies are facing lawsuits from women who have been harmed as a result of transvaginal mesh devices such as:
- Gynecare TVT
- Advantage Transvaginal Mid-Urethral Sling
Patients who have been injured by a surgical mesh implant and are considering legal action should contact a professional product liability lawyer as soon as possible.
Why should I choose Estey Bomberger to handle my case?
Product Liability lawyers at Estey Bomberger have accumulated years of experience litigating large corporations on behalf of wrongfully injured consumers. With a track record of successfully taking on large corporations, our attorneys have even against international medical device manufacturing companies recovered millions in settlements and verdicts for serious injury victims. For more information on how the transvaginal mesh sling failure lawyers at Estey Bomberger can help you, please call us today to schedule a free consultation.