On April 16, 2019, the Food and Drug Administration (FDA) ordered that all sales of surgical mesh products intended for transvaginal repair of anterior compartment prolapse (cystocele) stop immediately. This order came after the FDA made the determination that the manufacturers, Boston Scientific and Coloplast, have not demonstrated “reasonable assurance of safety and effectiveness for these devices.” The failure to show that transvaginal mesh products are reasonably safe and effective violates the premarket standard that applies to them as Class III or high-risk products. There are currently over 48,000 transvaginal mesh lawsuits pending across the country.
What are Transvaginal Mesh Patches Used to Treat?
Transvaginal mesh patches are intended to treat urinary incontinence and pelvic organ prolapse. These conditions are characterized by a weakening of the muscles and tissues in the pelvic area. This can lead to a loosening of the organs in the pelvic area resulting in symptoms such as urine leakage, low back pain, a feeling of constant pressure in the pelvic area, and painful intercourse. A transvaginal mesh patch is implanted surgically to provide support to the muscles in the pelvic area and alleviate these symptoms. However, after being treated with these patches, a number of serious side effects and complications have been reported.
Why are Transvaginal Mesh Patches Allegedly Dangerous?
The FDA has indicated that the makers of transvaginal mesh patches have failed to show that the benefits of the patches outweigh the risks involved. This means that the products are too dangerous to be used to treat women. As a result of these findings, the FDA ordered that sales of transvaginal mesh patches stop immediately. Over 48,000 lawsuits have been filed against the makers of transvaginal mesh products alleging that the company knew about these risks but failed to warn the public of the potential dangers. Lawsuits continue to be filed as women come forward and report injuries they have suffered.
Contact an Experienced Transvaginal Mesh Lawyer
If you or a loved one has been injured as a result of being treated with a transvaginal mesh patch, you may be entitled to compensation for your medical bills, lost income and pain and suffering, among other losses. Our firm is working with experienced transvaginal mesh lawyers across the country, who are investigating these cases. They may be able to file a transvaginal mesh lawsuit for you, and they charge no fee unless you win an award or settlement. For a free (no obligation) case evaluation, call our toll free number at 1-800-992-6878 or fill out a contact form online.