In October of 2008, TheU.S. Food and Drug Administration (FDA) issued a Public Health warninginvolving serious complications associated with surgical mesh placed through the vagina (transvaginal placement) to treat Pelvic organ prolapse (POP) and Stress urinary incontinence (SUI). In July of 2o11, the FDAupdated their warning toHealth care providers and recipients of implanted TransvaginalSurgical mesh, advising that the serious side effects from the aforementioned was“a continuing serious concern” and“not rare.”
If you are suffering from the side effects of TRANSVAGINAL SURGICAL MESH, please be assured you are not alone. The Yankowitz Law Firm understands what you are experiencing and would like to assist. Please contact The Yankowitz Law Firm @ 1-800-LAW-3333 and speak with one of our female professionals who understand and care.
Surgical mesh is a medical device that is generally used to repair weakened or damaged tissue. It is made from porous absorbable or non-absorbable synthetic material or absorbable biologic material. In urogynecologic procedures, surgical mesh is permanently implanted to reinforce the weakened vaginal wall to repair pelvic organ prolapse or to support the urethra to treat urinary incontinence.
Pelvic Organ Prolapse
Pelvic organ prolapse (POP) occurs when the tissues that hold the pelvic organs in place become weak or stretched. Thirty to fifty percent of women may experience POP in their lifetime . When POP happens, the organs bulge (prolapse) into the vagina and sometimes prolapse past the vaginal opening. More than one pelvic organ can prolapse at the same time. Organs that can be involved in POP include the bladder, the uterus, the rectum, the top of the vagina (vaginal apex) after a hysterectomy, and the bowel.
Stress Urinary Incontinence
Stress urinary incontinence (SUI) is a leakage of urine during moments of physical activity, such as coughing, sneezing, laughing, or exercise.
Transvaginal and Pelvic Mesh Complications and Failures
Complications reported to the FDA for surgical mesh devices for POP repair include:
- mesh erosion through the vagina (also called exposure, extrusion or protrusion)
- pain during sexual intercourse (dyspareunia)
- organ perforation
- urinary problems
- recurrent prolapse
- neuro-muscular problems
- vaginal scarring/shrinkage
- emotional problems
Many of the aforementioned complications require additional intervention, including medical or surgical treatment and hospitalization.
The FDA conducted a systematic review of the published scientific literature from 1996 – 2011 to evaluate the safety and effectiveness surgical mesh for POP and SUI. The review showed that transvaginal POP repair with mesh does not improve symptomatic results or quality of life over traditional non-mesh repair. Furthermore, the literature review revealed that:
- Mesh used in transvaginal POP repair introduces risks not present in traditional non-mesh surgery for POP repair.
- Mesh placed abdominally for POP repair appears to result in lower rates of mesh complications compared to transvaginal POP surgery with mesh.
- There is no evidence that transvaginal repair to support the top of the vagina (apical repair) or the back wall of the vagina (posterior repair) with mesh provides any added benefit compared to traditional surgery without mesh.
- While transvaginal surgical repair to correct weakened tissue between the bladder and vagina (anterior repair) with mesh augmentation may provide an anatomic benefit compared to traditional POP repair without mesh, this anatomic benefit may not result in better symptomatic results.
Erosion of mesh through the vagina is the most common and consistently reported mesh-related complication from transvaginal POP surgeries using mesh. Mesh erosion can require multiple surgeries to repair and can be debilitating for some women. In some cases, even multiple surgeries will not resolve the complication.
Mesh contraction (shrinkage) is associated with vaginal shortening, vaginal tightening and vaginal pain.
Both mesh erosion and mesh contraction may lead to severe pelvic pain, painful sexual intercourse or an inability to engage in sexual intercourse. Also, men may experience irritation and pain to the penis during sexual intercourse when the mesh is exposed in mesh erosion.
Notify your health care provider if you have complications or symptoms, including persistent vaginal bleeding or discharge, pelvic or groin pain or pain with sex.. Please ask your health care provider which device you had implanted. The following is a list of many of manufacturers and brands that were implanted in women:
- Avaulta Plus™ BioSynthetic Support System
- Avaulta Solo™ Synthetic Support System
- Faslata® Allograft
- Pelvicol® Tissue
- PelviSoft® Biomesh
- Pelvitex™ Polypropylene Mesh
- Advantage™ Sling System
- Obtryx® Curved Single
- Obtryx® Mesh Sling
- Prefyx Mid U™ Mesh Sling System
- Prefyx PPS™ System
- Ethicon TVT
- Gynecare TVT
- Gynemesh PS
- Prolene Polypropylene Mesh Patch
If you or someone you love suffered complications from the side effects related to a transvaginal mesh implant or transvaginal sling, you may be entitled to financial compensation based on the manufacturer’s failure to properly design these products or to adequately warn patients and doctors of mesh side effects. Protect your legal rights ! The Yankowitz Law Firm has recovered millions of dollars for victims of faulty products. Call 1-800-LAW-3333 for a complimentary confidential consultation.