Abscesses (pus-filled sores)
Pain during sexual intercourse
Vaginal shrinkage due to scar tissue
The complications may occur immediately after surgery or many years later. These complications can require surgical intervention such as revision surgery to try and remove the mesh. However, sometimes the mesh cannot be removed and multiple revision surgeries will be required.
Of the complications, vaginal mesh erosion, pain, and organ perforation are some of the most difficult to treat. Vaginal mesh erosion is the most common complication. It occurs when the transvaginal mesh erodes through the tissue and becomes visible. It is extremely painful, it can cause infections, and it can affect other areas of the body such as the bladder and rectum.
Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP)
SUI occurs when the bladder leaks urine during moments of greater physical activity because there is increased pressure on the bladder. The transvaginal mesh supports the urethra when the pelvic muscles become weak. Surgical treatment of SUI with mesh (often referred to as a bladder sling or vaginal tape) is the most common type of surgical procedure to correct the condition.
POP occurs when organs sag or fall into the vaginal canal because the pelvic muscles are weak. Usually, the bladder, uterus, rectum, or bowel are the organs involved in the prolapse, and the bladder is the most common. The transvaginal mesh is used to hold the organs up above the vaginal canal. The FDA has focused its regulatory efforts on transvaginal mesh for POP because the agency finds that procedure to be riskier.
Why is Transvaginal Mesh for POP Riskier?
In 2016, the FDA reclassified transvaginal mesh for POP from “moderate” risk to a “high” risk device. This means transvaginal mesh for POP is now a Class III device and manufacturers must submit and obtain approval of pre-market approval (PMA) applications to the FDA to help the agency make sure the implant is safe and effective. PMAs are the most stringent device review pathway and are reserved for the riskiest devices. The FDA explained, “the safety and effectiveness of surgical mesh for transvaginal POP repair has not been established.”
In April 2019, the FDA reviewed the PMAs from the two companies that manufactured transvaginal mesh for POP, Boston Scientific and Coloplast. Boston Scientific’s mesh included the Uphold Lite Vaginal Support System and the Xenform Soft Tissue Repair System. Coloplast’s device was the Restorelle DirectFix Anterior. After the review, the FDA denied the applications because the data did not provide “reasonable assurance of safety and effectiveness.” In other words, the FDA determined that the risks outweighed the benefits of using transvaginal mesh for POP treatment. As a result, the FDA ordered the two manufacturers to stop selling and distributing their products immediately. The companies then withdrew their transvaginal mesh for POP products from the market. It’s important to note that the transvaginal mesh for POP was not recalled; rather, the manufacturers stopped selling their products on the market. There has not been a transvaginal mesh device recall since Boston Scientific recalled ProteGen Sling in 1999.
As of January 31, 2019, the FDA and MAUDE received 69,000 adverse event reports for transvaginal mesh for POP. This statistic includes 64,600 injuries to patients and 383 deaths.
How GoldenbergLaw Can Help You
If you or a loved one suffered a complication after being implanted with a transvaginal mesh, contact the Medical Device Attorneys at GoldenbergLaw today. Medical device cases are complex, and you need a team with a track record of success. The GoldenbergLaw team has provided the Gold standard of advocacy to our clients for more than 35 years. Contact us today to learn what we can do for you!
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