Transvaginal Mesh Implants

News Alert:

Johnson & Johnson subsidiary Ethicon, manufacturer of several transvaginal mesh implants, announced that it is pulling four such products from the market, including:

  • Gynecare TVT Secur system
  • Gynecare Prosima Pelvic Floor Repair System
  • Gynecare Prolift Pelvic Floor Repair System
  • Gynecare Prolift+M Pelvic Floor Repair System

This represents a major victory for the thousands of women who have filed or plan to file transvaginal mesh lawsuits. Several other manufacturers of POP products have also recalled some of their pelvic organ prolapse mesh kits as well.

Transvaginal Mesh Patch Failure

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). The FDA has received more than 3,800 reports of adverse effects caused by the surgical mesh or during implantation of the patch.

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

  • 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.

FDA Alerts and Research Find Transvaginal Patches Unsafe

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

2011 Study Published – The New England Journal of Medicine published research showing an increased risk of complications associated with transvaginal mesh implants. Compared to colporrhaphy, a traditional treatment of POP, surgical mesh had a higher risk of defect 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

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 Published – 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 55,000 Lawsuits Filed Already

More than 55,000 women across the United States have filed lawsuits at the federal and state levels against ten manufacturers of transvaginal mesh patches:

  • 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 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