The wide use of vaginal mesh implants in women as a means of preventing pelvic organ prolapse in women has come under severe scrutiny and the USFDA (U.S. Food and Drug Administration) has come up with much stricter rules.
In what is being seen by many as a step in the right direction, the vaginal mesh implants were reclassified on Monday. They have been elevated from a ‘moderate risk’ category to a ‘high risk’ category.
While this adds an additional step to the manufacturing process as manufacturers must now submit pre-market approval applications to the FDA, it helps decrease the risk to the patients as the FDA can now assess the implants’ safety and effectiveness in a more thorough fashion. .
In pelvic organ prolapse some internal structures that support organs such as the bladder, bowel and uterus get stretched and weak. This typically happens after childbirth, a hysterectomy or menopause. The prolapse can present with symptoms like pelvic pain, urinary leakage and constipation. In many cases it also affects the woman’s sexual activity and desire.
For many years surgeons have tried to solve the problem of prolapse with the help of mesh implants to reinforce weakened pelvic floor muscles. But the problem with these devices is that they could cause bleeding, infection, bleeding, urinary problems and pain during intercourse.
According to Dr. William Maisel, deputy director of science and chief scientist at the FDA Center for Devices and Radiological Health, the new classification will bring into effect stronger clinical requirements which in turn will help reduce the significant risks associated with vaginal meshes.
In Dr. Maisel’s own words, “We intend to continue monitoring how women with this device are faring months and years after surgery through continued post-market surveillance measures.”
It’s important to note that the updated requirements apply only to the mesh implants placed through the vagina (trans-vaginal) to treat pelvic organ prolapse, and not to other uses of surgical mesh.
The new ruling will put added pressure on the trans-vaginal mesh implant manufacturers as they have just have 30 months to submit pre-market approval applications for the devices which are already on the market. As for all new devices, they must be approved under the new guidelines, before they can get to market in the United States.