If you are a woman who has undergone surgery for pelvic organ prolapse and have received a transvaginal mesh implant in your pelvic area, you may be at risk.
For women who have pelvic organ prolapse, mesh can be placed through the vagina in order to repair the pelvic organ prolapse (POP). FDA released a warning July 13, 2011, saying that patients who have the surgical mesh placement through the vagina to repair pelvic organ prolapse may be exposed to greater risk than other surgical options.
What you need to know:
1. FDA says there is no evidence of greater clinical benefit such as improved quality of life with the surgical placement of mesh.
2. Last year, there were about 100,000 POP repairs completed with the use of surgical mesh. About 75,000 of those were transvaginal procedures.
3. 1503 adverse event reports associated with the surgical placement of mesh used in POP from 2008 to 2010 have been reported to the FDA.
4. The most serious complications reported from the use of surgical placement of mesh include: bleeding; infections; organ perforation from surgical tools used in the mesh placement; urinary problems; mesh becoming exposed or protruding out of the vaginal tissue; and pain during sexual intercourse
5. FDA first issued a safety warning about the surgical placement of mesh because of increasing concerns about adverse events in 2008. Since this first warning, the number of adverse events has continued to increase. A review of scientific literature published between 1996 and 2010 comparing mesh surgeries to non-mesh surgeries was conducted by FDA. After this review, FDA suggested that many patients who undergo transvaginal POP repair with surgical placement of mesh are exposed to additional risks in comparison to patients who have POP repair with stitches alone.
6. An outside panel of experts in gynecology and obstetrics are meeting on September 8th-9th to further discuss the effectiveness and safety of surgical mesh placement used to treat POP and stress urinary incontinence. The panel will also discuss clinical studies that may be necessary and the risks of transvaginal POP repair.
What you need to do:
(If you have not had surgery already): FDA recommends you to ask your surgeon before surgery about all POP treatment options and understand why the surgeon may be recommending treatment of POP with mesh. Ask your surgeon about the treatment options that do no involve mesh. After surgery, continue with follow-up care after surgery and routine check-ups. If you have any complications, notify the surgeon immediately.
(For those who have had surgery): If you have already had POP surgery and do not know whether your surgeon used the surgical placement of mesh, contact your surgeon. You can also contact one of our transvaginal mesh implant lawyers and we can help you obtain this information for you.
The law firm of Childers, Schlueter and Smith, LLC based in Atlanta, Georgia continues to review and investigate potential transvaginal mesh implant cases on behalf of women all over the United States. Initial case consults are free of charge to all victims affected by defective and dangerous transvaginal mesh implants. Please feel free to contact our firm with any questions regarding the mesh implants.
All inquiries are completely confidential. In addition, they will be handled with compassion and total discretion. Our trained transvaginal mesh implant lawyers understand what to do and how to help.
Some of the more common polypropylene mesh products of concern are for pelvic organ prolapse (POP) and stress urinary incontinence (SUI) are:
CR Bard: (with Sofradim Production S.A.S. and/or Tissue Science Laboratories Limited)
Align Urethral Support System
Align TO Urethral Support System
Avaulta Anterior BioSynthetic Support System
Avaulta Posterior BioSynthetic Support System
Avaulta Plus Anterior BioSynthetic Support System
Avaulta Plus Posterior BioSynthetic Support System
Avaulta Solo Anterior Synthetic Support System
Avaulta Solo Posterior Synthetic Support System
InnerLace BioUrethral Support System
Pelvicol Acellular Collagen Matrix
PelviLace BioUrethral Support System
PelviLace TO Trans-obturator BioUrethral Support System
PelviSoft Acellular Collagen BioMesh
Pelvitex Polypropylene Mesh
Uretex SUP Pubourethral Sling
Uretex TO Trans-obturator Urethral Support System
Uretex TO2 Trans-obturator Urethral Support System
Uretex TO3 Trans-obturator Urethral Support System
Ethicon / Johnson & Johnson:
Gynecare Prolift Mesh
Prolift Total
Prolift Anterior
Prolift Posterior
Gynecare Prolift +M
Prolift +M Total
Prolift +M Anterior
Prolift +M Posterior
Gynecare Gynemesh
Gynecare Prolene Mesh
Gynecare Prolene Soft Mesh
Gynecare Prosima
Gynecare TVT Exact
Gynecare TVT Abbrevo
Gynecare TVT Retropubic System
Gynecare TVT (TVT)
Gynecare TVT Obturator (TVT-O)
Gynecare TVT Secur (TVT-S)
American Medical Systems:
Elevate Apical /Anterior (POP)
Elevate Apical/Posterior (POP)
Apogee (POP)
Perigee (POP)
Monarc Subfascial Hammock (For SUI)
Sparc Sling System (SUI)
Mini-Arc Precise Single Incision Sling (SUI)
Mini-Arc Single Incision Sling (SUI)
In-Fast Ultra Transvaginal Sling (SUI)
BioArc (SUI)
Boston Scientific:
Pinnacle
Uphold System
Advantage Sling System
Advantage Fit
Lynx Suprapubic Mid-Urethral System
Obtryx Mesh System
Obtryx Curved Single
Prefyx PPS System
Prefyx Mid U Mesh Sling System
Solyx
Repliform
Coloplast: (with Mpathy and/or Mentor)
T-Sling-Universal Polypropylene Sling;
Aris-Transobturator Sling System;
Supris-Suprapubic Sling System;
Novasilk-Synthetic Flat Mesh;
Suspend-Tutoplast Processed Fascia Lata;
Exair-Prolapse Repair System;
Axis-Tutoplast Processed Dermis;
Restorelle;
Smartmesh;
Omnisure;
Minitape;
Caldera:
T-Sling
Desara Sling
Tyco:
IVS Tunneller
Covidien:
Surgipro
