It is estimated that more than 50 percent of all women who have children will suffer some type of prolapse over the course of their lives and nearly 10 percent of these women will require surgery for this health condition. Pelvic Organ Prolapse happens when muscles and ligaments supporting the pelvic organs weaken or slip out of place. This may be a direct result of pregnancy where the muscles and ligaments are weakened by the added weight experienced during pregnancy. POP can also lead to bladder and bowel slippage which places abnormal pressure on the vaginal area causing pain and discomfort.
On April 16, , the FDA ordered all manufacturers of surgical mesh intended for transvaginal repair of anterior compartment prolapse cystocele to stop selling and distributing their products immediately. The FDA has determined that the manufacturers, Boston Scientific and Coloplast, have not demonstrated reasonable assurance of safety and effectiveness for these devices, which is the premarket standard that now applies to them since the agency reclassified them into class III high risk in Since the FDA has not received sufficient evidence to assure that the probable benefits of these devices outweigh their probable risks, the agency has concluded that these products do not have reasonable assurance of safety and effectiveness. The companies will have 10 days to submit their plans to withdraw these products from the market.
The pause and same restrictions, as outlined below, will remain in place until a set of conditions have been met. For more information, visit the mesh safety alert page. For the majority of patients, mesh surgery should not be performed during this period of high vigilance restriction.
As part of BAUS membership, registered members may join Urolink and up to three other sections which are relevant to their particular areas of practice. Membership of BAUS is open to any medical practitioner in urological practice interested in promoting the objects or the organisation. The pause on mesh surgery for stress incontinence see below remains in place, and this will be the case until a series of pre-specified conditions are met.