After being reclassified by the US FDA as a Class III high-risk device, the pelvic mesh for transvaginal repair surgery gets tighter requirements. To be more specific, the exact process that gets an increase in regulation will be the transvaginal Pelvic Organ Prolapse that consists of the pelvic muscles increased weakness, leading to an inability of supporting the weight of the uterus, bladder or other pelvic organs.
The process of surgically implanting a mesh in order to stop organs from prolapsing into the vaginal area has been used since the 1990s through transvaginal intervention while in the 1970s it was used through abdominal surgery. Although POP is not a life threatening disease, it causes rather severe symptoms like pains during intercourse, increased pressure in the lower abdominal area or leakage and chronic urge to urinate.
The reason why this reclassification was conducted stems from various complaints received by the FDA from women that underwent transvaginal POP repair surgery. The side effects mentioned in these complaints ranged from organ perforations to bleeding and increase in urination-related pains. Mesh surgery for those suffering from SUI, stress urinary incontinence, or POP surgery made through the abdominal area will remain as a class II treatment.
Women that developed a weakness in pelvical muscles after childbirth, eventually leading to POP transvaginal repairs, have already issued lawsuits towards mesh manufacturers like Boston Corp. Over 3,000 cases were resolved with the payment of $119 million in damages while another 6,000 were settled down due to the company’s dismissal of violation. Endo International PLC also went through similar lawsuits, with over 20,000 cases resulting in $830 million in adjustments due to the allegations made against their manufactured mesh kits.
Although experts have different opinions in regards to transvaginal mesh devices, with some of them stating that this type of surgery requires a shortened recovery time when compared to abdominal surgery, the FDA will continue surveillance on the matter over the next few years. This inquiry will continue for months and years after the surgery has been done in order to see if any adverse effects appear, alongside a continued market surveillance in regards to the safety of said meshes.
Mesh manufacturing companies have up to 30 months time in order to submit a premarket approval to the FDA in order to continue the commercialization of the devices that are still used in hospitals and clinics. If their risk is deemed low enough for these to re-enter the market, this decision is completely in the hands of the FDA.
Taking into account the fact that the pelvic mesh for transvaginal repair surgery gets tighter requirements, women that currently suffer from POP will have to undergo a more invasive method of abdominal surgery in order to apply these meshes. The less invasive method, in the form of vaginal entry, will revert to a class II method only after a couple of years, being completely dependent on both the manufacturers as well as the FDA.