Vaginal mesh has been recognized worldwide as a medical device used in the surgical repairs of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI), but recently recipients complaining about the complications caused by these medical devices build up. Filed vaginal lawsuits also increased as discussions on the possibility of vaginal mesh products to be recalled created a public commotion.
Surgical mesh products were first introduced for the treatment of hernia in 1950 and it was recorded to be effective most of the time. But after it was used for the repair of POP and SUI, numerous complications were reported.
Primary adverse reactions that result from vaginal mesh surgery include erosion of the mesh, development of infections, hemorrhage, recurrence of prolapse, difficulty in voiding, perforation of any of the pelvic organs, and pain. Among these, mesh erosion is the most difficult to treat once it occurs; it can even expose the patient to even more dangerous complications that require more surgeries to correct. Some may need blood transfusions and other painful clinical interventions, and some may even be irreversible and cause life-altering injuries or death.
The U.S. Food and Drug Administration (FDA) ensures that the medical products available in the market are safe and effective for the consumers to use. After the negative reports associated with vaginal mesh, the FDA made an announcement informing doctors and patients of the serious risks caused by vaginal mesh surgery and made recommendations on how to lessen these complications.
A consumer advocacy group called Public Citizen filed a request for the recall of all non-absorbable mesh products, since most vaginal mesh products are composed of non-absorbable synthetics known as polypropylene.
Public Citizen stated that vaginal mesh products present unreasonable risks of injuries and even deaths. they suggested that production of all non-absorbable mesh products be stopped, mesh manufacturers should remove all non-absorbable mesh devices in the market, and future vaginal mesh devices should undergo premarket approval application to test for efficacy and safety.
The FDA has not come up with a decision yet about
vaginal mesh recall. However, it is currently investigating the possibility of these medical devices to be removed from the market. Because more women are exposed to POP and SUI, an increasing number of vaginal mesh procedures and complications are at hand. In the mean time, FDA encourages health care providers and patients to report any complication that may be related to vaginal mesh implantations, to better understand the risks involved with vaginal mesh products.
