Risks with Cystocele and Rectocele Mesh Repair , FDA Warnings, Vaginal mesh lawyers
In July 2011, the FDA released a safety communication warning healthcare providers of the serious risks associated with surgical mesh used to repair pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Specifically, the FDA stated that complications were not rare, and that surgery with the mesh may be no better than traditional surgery options that don’t use mesh.
Public Citizen and Vaginal mesh
In October 25, 2011, a consumer advocacy group called Public Citizen submitted an appeal to the FDA that all non-absorbable vaginal mesh be recalled. They stressed that there is a need for these non-absorbable vaginal meshes to be removed from the market since it’s benefits over other non-mesh procedures used to repair POP and SUI were unseen, and patients who received them developed fatal reactions. The group also recommends that all non-absorbable vaginal mesh be tested appropriately for safety and effectiveness before the FDA approves its availability in the market.
FDA 510 (K) Process
Manufacturers needed only to show they were similar to devices already on the market to gain approval through the FDA’s 510(k) approval process. The remaining eight recalled devices didn’t have to go through any kind of FDA review. Of the 113 recalls, 35 were for cardiovascular devices, including automated external defibrillators, or AEDs, and only 12 of them had been required to undergo patient testing.
POP repair surgeries may include cystocele and rectocele.
Unfortunately, complications have been found with both.
Types of POP Repair Include Cystocele and Rectocele.The sling procedure, or suburethral sling procedure, refers to a particular kind of surgery using ancillary material to aid in closure of the urethral sphincter function of the bladder. It is performed as a treatment of severe urinary incontinence. The sling procedure, also known as the suburethral fascial sling or the pubovaginal sling, has many forms due to advances in the types of material used for the sling. Some popular types of sling material are Teflon (polytetrafluoroethylene), Gore-Tex ® , and rectus fascia (fibrous tissue of the rectum).
Cystocele and rectocele repair
- Cystocele—bladder prolapse
- Rectocele—rectal prolapse (end of the large intestine, or rectum)
- Uterine prolapse
- Vaginal prolapse
- Enterocele—herniated small bowel
Mesh was initially incorporated into POP surgical repair because it offered more support to the affected organ and helped shore up surrounding muscles and tissues. Since the risk for recurrence of prolapse is high in women who have cystocele surgery and rectocele surgery, the hope was that surgical mesh would help sustain the repair. The FDA received many reports, however, or cystocele mesh complications and rectocele mesh complications.
Mesh complications
- erosion of mesh
- serious infection
- recurrence of pop / sui
- perforation
- pain
- corrective surgeries
- injury to other organs
- vaginal scarring
- urinary problems
- hardening of mesh
Cystocele Mesh Complications and Rectocele Mesh Complications
During cystocele surgery, transvaginal mesh is inserted through the vagina to help act as a barrier and to hold the bladder in place. The mesh is also intended to help stop related problems like incontinence.
A rectocele occurs when the thin wall of tissue separating the rectum from the vagina weakens, allowing the front of the rectum to bulge into the vagina. During rectocele surgery, excess stretched tissue is removed through the vagina, and a mesh patch may be used to support and strengthen the wall. (Surgery may also proceed from the abdomen, anus, or perineum.)
Though surgical mesh does seem to provide better support for pelvic organs, cystocele mesh complications and rectocele mesh complications made the improvement a moot point. The FDA, in its 2011 warning, mentioned that it had received nearly 3,000 reports of vaginal mesh complications between 2008 and 2010, with the most common being mesh erosion through the vagina. Mesh erosion can require multiple surgeries to repair and may be extremely debilitating.
Other cystocele mesh complications and rectocele mesh complications included pain, infection, bleeding, pain during sex, organ perforation, urinary problems, recurrent prolapse, vaginal scarring/shrinkage, and neuro-muscular problems. Many required additional surgical treatment and hospitalization.
Cystocele Surgery and Rectocele Surgery
Cystocele, urethrocele, enterocele, and rectocele are particularly likely to occur together. Urethrocele is virtually always accompanied by cystocele (cystourethrocele). Cystocele and cystourethrocele commonly develop when the pubocervical vesical fascia is weakened. Enterocele usually occurs after a hysterectomy. Weakness in the pubocervical fascia and rectovaginal fascia allows the apex of the vagina, which contains the peritoneum and small bowel, to descend. Rectocele results from disruption of the levator ani muscles.
Severity of these disorders can be graded based on level of protrusion:
- 1st degree: To the upper vagina
- 2nd degree: To the introitus
- 3rd degree: External to the introitus
If you have been injured due to a vaginal mesh from any of the manufactuirers listed below contact Vaginal mesh Helpline 1 877 522-2123
Manufacturers
Johnson & Johnson
- Ethicon TVT
- Gynecare Prolift
- Gynecare Prosima
- Gynecare TVT
- Gynemesh PS
C.R. Bard
- Avaulta PlusT BioSynthetic Support
- Avaulta SoloT Synthetic Support
- Faslata Allograft
- PelvitexT Polypropylene Mesh
- Pelvicol Tissue
- PelviSoft Biomesh
Boston Scientific
- AdvantageT Sling System
- Prefyx Mid UT Mesh Sling System
- Prefyx PPST System
- Obtryx Curved Single
- ObtryxMesh Sling
- Arise
- Pinnacle
- Solyx
- Lynx
American Medical Systems
- SPARC
- BioArc
- MiniArc
- Apogee
- Elevate
- Monarc
- In-Fast
- Perigree
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