Transvaginal Mesh Lawsuits
Surgical pelvic mesh is a medical device, made of polypropylene, a form of plastic, commonly referred to as transvaginal or vaginal mesh, tape, hammock, or bladder sling products. It is designed to repair pelvic organ prolapse (POP) and to treat stress urinary incontinence (SUI). Unfortunately, the use of this device has led to severe complications, resulting in extreme pain and other symptoms, and frequently necessitating further surgery.
FDA Approval: Vaginal mesh was approved by the FDA under a controversial system called the 510(k) premarket notification process, a system that allows a manufacturer to put a product on the market without any prior clinical testing on human subjects to assess the safety and efficacy of these devices. However, as early as October 20, 2008 the FDA issued a public health notification, warning health care practitioners about the serious complications associated with vaginal mesh products.
On July 13, 2011, under the pressure of overwhelming evidence, the FDA issued a second safety communication to address the additional 2,874 reports of transvaginal mesh complications between 2008 and 2010. Specifically, the FDA stated: (i) Complications related to transvaginal mesh surgery are NOT rare; (ii) There is no evidence that transvaginal mesh repair is more effective than traditional non mesh repair; and (iii) Transvaginal mesh surgery exposes patients to greater risk than traditional non mesh repair. Find the full text of the July 2011 here.
Despite this, large Pharmaceutical Companies continue to produce the surgical pelvic mesh. These companies have a duty to produce safe products and to warn of any adverse health effects, which they failed to do correctly. The women who have been injured by these products have a right to compensation.
Manufacturers and Products
These are some of Pharmaceutical Companies that produce surgical pelvic mesh, and the names of the products that they produce:
|Boston Scientific Corporation||The Uphold Vaginal Support System; The Pinnacle Pelvic Floor Repair Kit; the Advantage Transvaginal Mid Urethral Sling System; The Advantage Fit System; The Lynx Suprapublic Mid-Urethral Sling System; The Obtryx Transobturator Mid-Urethral Sling System; The Prefyx PPS System; and the Solyx SIS System|
|Johnson & Johnson/Ethicon, Inc.||Prolene Mesh/Prolene Soft Mesh, Gynemesh, Gynemesh PS, TVT, TVT-Obturator (TVT-O), TVT-Secur (TVT-S), TVT Exact, TVT Abbrevo, Prolift, Prolift +M, Prosima|
|American Medical Systems
(AMS); Endo Pharmaceuticals,
Inc.; Endo Pharmaceuticals
Holdings Inc.; or Endo Health
|Apogee, Perigee, Mini-Arc Sling, Monarc Subfascial, Hammock, Sparc, Bio-Arc, In-Fast Ultra, Influence In-Fast, and Elevate|
|Caldera Medical||Ascend Anterior, Ascend Posterior|
|C.R. Bard, Inc. (Bard); Sofradim
Production SAS (Sofradim); or
Tissues Science Laboratories
|The Align Urethral Support System; The Align TO
Urethral Support System; The Avaulta Anterior
BioSynthetic Support System; The Avaulta Posterior
BioSynthetic Support System; The Avaulta Plus Anterior
BioSynethic Support System; The Avaulta Plus Posterior
BioSynthetic Support System; The Avaulta Solo Anterior
Synthetic Support System; The Avaulta Solo Posterior
Synthetic Support System; The InnerLace BioUrethral
Support System; The Pelvicol Acellular Collagen Matrix;
The Pelvilace BioUrethral Support System; The PelviLace
TO Trans-obturator BioUrethral Support System; The PelviSoft Accellular Collagen BioMesh; The Pelvitex Polypropylene Mesh; The Uretex SUP Pubourethral Sling; The Uretex TO Trans-obturator Urethral Support System; The Uretex TO2 Trans-obturator Urethral Support System; and The Uretex TO3 Trans-obturator Urethral Support System
|Coloplast Corp.; Coloplast
Manufacturing; or Porges, S.A.
|T-Sling-Universal Polypropylene Sling, Aris
Transobturator Sling System, Surpris-Suprapubic Sling System, Novasilk-Synthetic FlatMesh, Exair-Prolapse Repair System, Restorelle, Smartmesh, Omnisure, Minitape, Suspend-Tutoplast Processed Fascia Lata, and Axis-Tutoplast Processed Dermis
|Cook Medical, Inc.||Surgisis Biodesign Tension-Free Urethral Sling; Surgisis Biodesign Anterior Pelvic Floor Graft; Surgisis Biodesign Posterior Pelvic Floor Graft; Cook Urological Stratasis Urethral Sling; Stratasis Tension Free Urethral Sling|