Thousands of cases have been filed against manufacturers for mesh used in both pelvic organ prolapse and stress urinary incontinence surgeries. Seemingly in response to these lawsuits (although this has not been publicly stated), manufacturers have recalled some of their mesh products.
Vaginal mesh was introduced in the late 1990s to correct pelvic organ prolapse and stress urinary incontinence that occurs when pelvic muscles weaken and pelvic organs (bladder, uterus or rectum) drop into the vagina. These conditions can typically occur in women after childbirth, hysterectomies, or menopause. Generally, transvaginal mesh is composed of a polypropylene/synthetic material, but can also consist of a biologic material or a combination of the two.
Surgical mesh is a Class II device, meaning that it is not required to go through the Federal & Drug Administration’s (FDA) pre-market review process. Instead, surgical mesh was introduced to the market through the regulatory process known as the Section 510(k) approval process. Section 510(k) only requires the manufacturer to show their product is “substantially similar” to a “predicate device.” A “predicate device” is a Class II device that is already on the market. Therefore, vaginal mesh manufactures cited mesh used for hernia repair to be the predicate device that was substantially similar to their product. The FDA approved and vaginal mesh was introduced to the market without having any clinical data. However, because the manufacturers used Section 510(k) process to streamline their products, they are not exempted from liability.
The FDA requires physicians and hospitals to report deaths and serious complications associated with the use of medical devices. In 2008, after thousands of reports, the FDA issued a public notification acknowledging that transvaginal mesh could cause serious complications in women. It said these complications were rare and physicians should obtain specialized training, inform patients of the risks associated with the mesh, and if available, provide the patient with a copy of the labeling. Despite the public notification, even more complications were reported. These complications include infections, severe pain, urinary problems, vaginal bleeding, organ perforation, painful intercourse, recurrent organ prolapse, vaginal scarring/shrinkage, and mesh erosion. In addition to these complications, there are increased risks and harm from additional surgeries to correct these problems.
The FDA began to conduct a review of scientific literature from 1996 through 2011 to review the safety and effectiveness of transvaginal mesh. The results of the review sparked the FDA to release its findings in June 2011 to the general public saying it could find no benefit to the patient in using synthetic mesh compared to using traditional forms of pelvic organ prolapse repair. The FDA specifically said that implanting vaginal mesh introduces the patient to additional harm not present in traditional forms of pelvic organ prolapse repair. However, these warnings were only for the use of mesh in pelvic organ prolapse, not stress urinary incontinence. At this point, the FDA seem to agree with mesh manufacturers that mesh used for stress urinary incontinence is more effective than traditional repair. Thousands of cases have been filed against manufacturers for mesh used in both pelvic organ prolapse and stress urinary incontinence surgeries. Seemingly in response to these lawsuits (although this has not been publicly stated), manufacturers have recalled some of their mesh products. However, despite the ongoing litigation, vaginal mesh is still used daily to treat women for pelvic organ prolapse and stress urinary incontinence.