The banning of all mesh for prolapse by the FDA has failed to recognize that there is a major difference between mesh sheets applied behind the vagina for POP and repair of POP by shortening and reinforcing damaged suspensory ligaments, much as is used in the midurethral sling (MUS) which retains endorsement by the FDA. Mesh sheets interfere with the vaginal elasticity essential for function and may cause pain and massive urine loss post-operatively, in some cases; tapes far less so, as they have little contact with vagina and work by shortening and reinforcing damaged ligaments in the same way as the MUS operation. The main pathogenesis of POP is leaching out of collagen after the menopause. Weakened ligaments cannot support the organs so they prolapse. Only artificial collagenous neoligaments created by implanted tapes (as per the MUS) can create the new collagen required to repair these ligaments.
The major advances developed over the past 30 years for treatment of POP using these ligament repair techniques has in one stroke been abolished. The treatment of POP has been set back 100 years. In their twilight years, many women will suffer the consequences of loose posterior ligaments, major prolapse, urge, nocturia, chronic pelvic pain, obstructed micturition defecation and fecal incontinence. The FDA needs to reconsider its ban, at least for tapes, which are supported by individual, multicentre and long-term studies.
Corresponding Author: ABENDSTEIN B.|