Based on their most recent official announcement, FDA adds transvaginal mesh implants to class III risk procedures. The administration has labeled this medical procedure as highly dangerous considering that many female patients have experienced complications in the past years.
The FDA has issued numerous warnings in the past concerning the dangers that women subject themselves to when they agree to use transvaginal mesh implants. FDA’s warnings were made based on the negative reports that the administration has received from medical experts.
After following the medical evolution of women with mesh implants, the FDA has agreed that this is a class III procedure. Previously, the surgical intervention was regarded as a class II procedure, but the risks are too high, in experts’ opinion.
The current class modification is only related to transvaginal meshes that are normally used for the repair of pelvic organ prolapse also known as POP. This condition presupposes a weakening of the pelvic muscles and the drop of the bladder, the uterus and the bowel into the vagina. Women with this condition often complain of pelvic pains, constipation, urinary difficulties as well as painful intercourse.
The FDA made it all clear through their most recent announcement that only the POP transvaginal meshes will be inserted in the class III procedures. The other surgical intervention for abdominal POP or those involving meshes for the treatment of stress urinary incontinence will continue to be regarded as moderately risky (class II).
Transvaginal POP meshes are now highly risky because they can cause severe complications. Most women, who have resorted to this type of medical procedure have experienced infection, bleeding, perforation of adjacent organs and urinary problems. Neither did they get rid of pelvic pains and painful intercourses; on the contrary, these have become unbearable.
Special measures will be imposed to manufacturers of POP meshes. They will have to release a PMA within a 30-month period for those medical devices that are already on the market. Meshes that have not been released on the market will get a PMA before they are marketed, the FDA has concluded.
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