FDA Warns About The Transvaginal Mesh Patch

The US Food and Drug Administration (FDA) had cautioned that the use of transvaginal mesh can depict patients to a very greater risk of complications than the general contemporary methods of surgical vaginal repair. The FDA has also stated that patients undergoing mesh repair surgery will be prone to experience severe side effects including vaginal mesh erosion and organ perforation.

Transvaginal mesh, transvaginal patch or transvaginal sling is a type of surgical mesh which is used for the repair of pelvic organ prolapse (POP) or stress urinary incontinence (SUI) in human females. Gynecologists initially started to use surgical mesh to repair POP or SUI in the early 1970s and gradually the manufacturers started to develop specially designed products which are intended to use in the surgeries.

The FDA has been keeping on warning about the several complications linked to the use of transvaginal mesh, including the vaginal mesh erosion, unbearable pain, opportunistic infections, urinary problems, uncontrolled bleeding and organ perforation. Since 2007, the reports of complications linked with the use of surgical mesh for POP repair surgery have risen to five folds the number of reports got over the preceding three years.

More than 1000+ transvaginal mesh lawsuits have been filed against the makers and the manufacturers of these products. In addition to unbearable pains and other side effects, some patients are in need of repeat surgeries in order to help out to correct complications with their transvaginal mesh.

Patients who face pain or other related problems with transvaginal mesh may be forced to undergo a repair surgery – a surgery done in order to correct problems that occurred after the mesh implantation.

The most common side effect reported so far by transvaginal mesh implanted patients is the erosion of the mesh into the vaginal tissue. Patients who are experiencing vaginal mesh erosion are in a compulsion to undergo multiple surgeries in order to correct this problem. The FDA has mentioned that even in cases where multiple repair surgeries are performed, it might still be impossible for doctors to completely treat the complications caused by transvaginal mesh products.

The FDA has clearly mentioned that complications from surgeries with transvaginal mesh were more frequent than the agency had previously believed. Manufacturers will have to use the ordered clinical trials to work on the rates of organ damage, transvaginal mesh complications and also the quality of life for female implant patients.

A recent study has found that transvaginal mesh does not meet the requirements and fails nearly one third of all patients within a period of 7 years of receiving the device. Published in a peer reviewed journal, the study followed 215 women who received transvaginal mesh to treat their pelvic prolapse for 7 years.

About 1 in 4 women had suffered from pelvic organ prolapse or stress urinary incontinence, and between 11% and 19% had received mesh surgery to correct it. However, of the total women in the study, nearly one third saw their problems turning back to them, with about 17% requiring additional palliative and surgical procedures to correct transvaginal mesh complications.