Transvaginal Mesh Implants

News Alert:

November 2014: Jurors in two separate trials sided against vaginal mesh manufacturer Boston Scientific. In a West Virginia case, the jury awarded four women who filed lawsuits against the company $18.5 million. In another case in Florida, the jury awarded $26.7 million to four injured women. Thousands of lawsuits remained pending against Boston Scientific and numerous other vaginal mesh manufacturers.

These verdicts are not the only ones mesh victims have won. They represent a major victory for the thousands of women who have filed or plan to file transvaginal mesh lawsuits

Transvaginal Mesh Patch Failures

A July 2011 FDA alert warns of serious complications associated with transvaginal mesh patches when implanted to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI). That same year, the New England Journal of Medicine compared vaginal mesh to colporrhaphy, a traditional treatment of POP, and found vaginal mash carries greater risks, including:

  • 7 times the risk of bladder perforation
  • Nearly twice the risk of urinary incontinence (loss of bladder control)
  • 3.2 percent of women required follow-up surgery to correct problems

According to the FDA, significant complications resulting from transvaginal mesh patches are not rare and commonly include:

  • Erosion of the vaginal tissue
  • Infection
  • Bleeding
  • Pelvic pain
  • Urinary problems such as incontinence
  • Pain during sexual intercourse (dyspareunia)
  • Organ perforation (puncturing) from surgical tools during mesh implantation
  • Vaginal scarring/shrinkage
  • Nerve damage

Less frequent problems included:

  • Return of POP
  • Return of SUI
  • Neuro-muscular problems
  • Emotional problems

If you have suffered complications due to the implantation of a transvaginal patch to treat POP or SUI, contact the experienced medical device lawyers of Childers, Schlueter & Smith, LLC for a free consultation today by calling us toll-free at (800) 641-0098 or by filling out the form on this page. All inquires are completely confidential.

Transvaginal Mesh Timeline

2011 FDA Alert: Serious and painful complications are associated with the transvaginal placement of surgical mesh, and their occurrence is not rare. The FDA also found the risky surgical mesh treatment of POP to be no more effective than traditional treatment.

2008 to 2010: FDA received 2,874 more reports of adverse complications linked to transvaginal mesh repair of POP and stress urinary incontinence (SUI). This brings the total adverse reports to over 3,800.

2010 Study: A study featured in the Obstetrics & Gynecology journal had to be terminated due to the extent of injuries to participants who received the transvaginal mesh patch. Of the women who were treated with the surgical mesh, 15 percent experienced erosions, and other complications included two cystotomies (bladder incision) and one blood transfusion.

2005 to 2008: FDA received more than 1,000 reports from nine surgical mesh manufacturers about complications related to the device and its treatment of POP and SUI.

Over 68,000 Lawsuits Filed Already

More than 68,000 women across the U.S. have filed lawsuits at the federal and state levels against manufacturers of transvaginal mesh patches, including:

  • C.R. Bard (along with TSL and Sofradim)
  • Johnson & Johnson (Ethicon, Inc.)
  • American Medical Systems
  • Boston Scientific
  • Coloplast
  • Coviden
  • Caldera
  • Tyco

What Should You Do?

If you have suffered complications due to the implantation of a transvaginal patch to treat POP or SUI, you are not alone, and may have a right to compensation. By filing a claim against the surgical mesh manufacturer, you could receive compensation for medical costs, lost wages, other financial burdens and for the pain and suffering caused by this defective medical device. You will also send a clear message to the manufacturer that it is unacceptable to sell medical devices that harm innocent people.

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

Contact Us

Contact the experienced medical device lawyers of Childers, Schlueter & Smith, LLC. for a free initial consultation. We will listen to your story and explain your legal rights to help you choose the best course of action for your claim.

Call us toll-free at (800) 641-0098