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Medical Devices Defective Drugs Transvaginal Mesh

Transvaginal Mesh Lawsuits

$26.7 Million and $18.5 Million Verdicts Against Boston Scientific 

$26.7 million and $18.5 million verdicts against Boston Scientific were awarded in two transvaginal mesh MDL trials. On November 13, 2014, a Miami, Florida jury awarded $26.7 million to four women implanted with Boston Scientific’s Pinnacle mesh devices. On November 20, 2014,  a Charleston, West Virginia jury awarded  $18.5 million to four women implanted with Boston Scientific’s Obtryx mid-urethral slings. The Obtryx verdict included $4 million in punitive damages, with $1 million awarded to each plaintiff.

The women in the Florida Pinnacle trial were each awarded between $6.5 million and $6.7 million. Boston Scientific’s Pinnacle mesh devices were implanted during pelvic organ prolapse surgeries and are no longer on the market. The individual awards for the women in the Pinnacle mesh trial include: 

  1. Amal Eghnayem – $6.7 + million;
  2. Margarita Dotres – $6.7 + million;
  3. Mania Nunez – $6.7 + million; and
  4. Juana Betancourt – $6.5 + million

The women in the West Virginia Obtryx sling trial were each awarded between $3.25 million to $4.25 million, plus an additional $1 million each for punitive damages. The Obtryx sling devices are implanted during stress urinary incontinence surgeries and are still on the market. The individual awards for the women in the Obtryx sling trial include: 

  1. Jeanie Blankenship – $4.25 million +  $1 million punitive damages;
  2. Chris Wilson – $3.75 million +  $1 million punitive damages;
  3. Carol Campbell – $3.25 million + $1 million  punitive damages; and
  4. Jacquelyn Tyree  – $3.25 million + $1 million punitive damages

Upcoming Bellwether Trials Against C. R. Bard and Ethicon/Johnson and Johnson

Transvaginal mesh MDL trials are scheduled for the next two months against C.R. Bard and Ethicon/Johnson and Johnson.  The verdicts in the bellwether trials assist in the evaluation and resolution of the remaining cases pending in litigation. Over 66,000 pelvic mesh cases against seven manufacturers are consolidated in the MDL. Ethicon/JJ lawsuits are in the majority, with close to 22,000, followed by American Medical Systems nearing 19,000, Boston Scientific lawsuits approximate 14,000, and C.R. Bard lawsuits number over 10,000. Coloplast, Cook and Neomedic lawsuits are in smaller numbers.

TVM MDL Bellwether Trial Schedule

In multidistrict litigation,  exemplar cases, called bellwethers, are chosen by the lawyers and Judge. The bellwether trial schedule is updated as follows:

MDL No. 2327 | In Re Ethicon, Inc., Pelvic Repair System Products Liability Litigation

  • Dianne Bellew v. Ethicon, Inc., et al. (Prolift) Trial begins December 4, 2014
  • Carolyn Lewis v. Ethicon, et al. Defense Judgment
  • Huskey v. Ethicon, et al. $3.27 Million Verdict for Plaintiffs
  • Brenda Lehrer v. Ethicon, Inc., et al. (Prolift) dismissed

MDL No. 2187 | In Re C. R. Bard, Inc., Pelvic Repair System Products Liability Litigation

  • To Be Announced – Trials starting January 30, 2015.
  • Donna Cisson v. Bard, Inc.  - $2 Million Verdict
  • Wanda Queen v. Bard, Inc. 2:11-cv-00012  - Settled.
  • Carolyn Jones v. Bard, Inc. 2:11-cv-00114 - Settled.

MDL No. 2326 | In Re Boston Scientific Corp. Pelvic Repair System Products Liability Litigation

Jacquelyn Tyree, et al. v. Boston Scientific Corp. Trial – $18.5 Million:

  1. Jeanie Blankenship – $4.25 million +  $1 million punitive damages
  2. Chris Wilson – $3.75 million +  $1 million punitive damages
  3. Carol Campbell – $3.25 million + $1 million  punitive damages
  4. Jacquelyn Tyree  – $3.25 million + $1 million punitive damages

Eghnayem v. Boston Scientific (Florida Pinnacle) Trial – $26.7 Million Total with individual awards:

  1. Amal Eghnayem – $6.7 + million;
  2. Margarita Dotres – $6.7 + million;
  3. Mania Nunez – $6.7 + million; and
  4. Juana Betancourt – $6.5 + million

MDL No. 2325 | In Re American Medical Systems, Inc., Pelvic Repair System Product Liability Litigation

1 – 5. The following cases have been resolved and their trials cancelled: Serrano 2:12-cv-03719; Jilovec 2:12-cv-05561; Weiler 2:12-cv-05836; Fontes 2:12-cv-02472; and Najor 2:12-cv-6722.

6. Pattison v. AMS, 2:12-cv-7154, is continued until further notice by the court.

MDL No. 2440 | In Re Cook Medical, Inc., Pelvic Repair System Products Liability Litigation

  • Bellwether Trials To Be Named: April 20, 2015 8:30 am, May 18, 2015 at 8:30 am, June 8, 2015

MDL No. 2387 | In Re Coloplast Corp. Pelvic Support Systems Products Liability Litigation

There are no bellwether trials scheduled.

MDL No. 2511 | In Re Neomedic Pelvic Repair System Products Liability Litigation

There are no bellwether trials scheduled.

Transvaginal Mesh Verdicts and Settlements

As of November 20, 2014, the plaintiffs have won nine trials  for 14 transvaginal mesh plaintiffs and the defendants have won three. An undisclosed number of plaintiffs have entered into confidential settlement agreements. A brief summary of the verdict awards, plaintiffs, manufacturers, products, jurisdictions and venues follows:

7/12: $5.5 million – Christine Scott – C.R. Bard Avaulta Plus –  CA

2/13: $11.11 million – Linda Gross – Ethicon/JJ Prolift – NJ

8/13: $2 million – Donna Cisson – C.R. Bard Avaulta – MDL WV

2/14: $0 – Carolyn Lewis - Ethicon/JJ TVT-O – MDL WV

4/14: $1.2 million – Linda Batiste – Ethicon/JJ TVT-O  - TX

7/14: $0 - Diane Albright - Boston Scientific Pinnacle – MA

8/14: $0 – Maria Cardenas – Boston Scientific Obtryx – MA

9/14: $3.27 million – Jo Huskey – Ethicon/JJ TVT-O – MDL WV

9/14: $73.465 million – Martha Salazar – Boston Scientific Obtryx – TX

11/14: $6.7+ million – Amal Eghnayem – Boston Scientific Pinnacle – MDL FL

$6.7+ million – Margarita Dotres – Boston Scientific Pinnacle – MDL FL

$6.7+ million – Mania Nunez – Boston Scientific Pinnacle – MDL FL

$6.5+ million – Juana Betancourt – Boston Scientific Pinnacle – MDL FL

11/14: $5.25 million – Jeanie Blankenship – Boston Scientific Obtryx –  MDL WV

$4.75 million – Chris Wilson – Boston Scientific Obtryx – MDL WV

$4.25 million – Carol Campbell – Boston Scientific Obtryx – MDL WV

$4.25 million – Jacquelyn Tyree – Boston Scientific Obtryx – MDL WV

Transvaginal Mesh Adverse Events

Transvaginal mesh and vaginal sling products have been linked to thousands of reported serious, life-threatening side effects or adverse events from seven surgical mesh manufacturers. The complications are associated with surgical mesh devices used to repair Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). The mesh devices are typically placed transvaginally for minimally invasive placement. Complications include:

  • erosion through the vaginal tissue
  • mesh contraction
  • mesh extrusion
  • inflammation
  • fistula
  • infection and abscess
  • pain
  • blood loss
  • chronic and acute nerve damage
  • pudendal nerve damage
  • pelvic floor damage
  • scar tissue
  • chronic pelvic pain
  • urinary problems and/or incontinence
  • recurrence of prolapse
  • bowel, bladder, and blood vessel perforation
  • dyspareunia or pain during sexual intercourse

Treatment of the complications includes additional surgical procedures to revise or remove the mesh, blood transfusions, drainage of hematomas, drainage of abscesses from infection, IV medication, pain injections, botox injections, physical therapy, among other treatments to alleviate the complications. 

In July 1, 2012, Bard stopped selling the Avaulta Mesh in the United States because the FDA required additional clinical trials and testing.

On June 4, 2012: Johnson and Johnson/Ethicon withdrew four mesh products from the US Market, including its controversial Gynecare Prolift, Prolift+ M, TVT Secur and Prosima systems.

History of Warnings:

Surgical mesh is a metallic or polymeric screen surgically implanted to reinforce and support weakened soft tissue or bone. On the market since the 1950s for use in abdominal hernias, gynecologists in the 1970s began using surgical mesh to reinforce vaginal tissue to treat pelvic organ prolapse. In the 1990s, surgeons began using surgical mesh to treat stress urinary incontinence in women.

Transvaginal mesh was approved for sale through the 510(k) process simply by comparing it to the kind of mesh used to treat abdominal hernias. Most transvaginal mesh products on the market today are based on Boston Scientific Corp.’s ProteGen mesh, which the FDA approved in 1996 as the first surgical mesh to treat stress urinary incontinence. Two years later, the FDA approved Johnson & Johnson’s Gynecare TVT mesh through the 510(k) process after the company claimed the mesh was substantially equivalent to ProteGen.

However, in October, 1999, the FDA recalled Boston Scientific’s ProteGen sling due to the large number of complications experienced by women, including erosion of the vaginal tissues. The complete irony is that a majority of the transvaginal mesh are based upon this recalled defective device.

On October 20, 2008, the U.S. Food & Drug Administration (FDA) issued an urgent public health notification to physicians and patients regarding serious complications associated with transvaginal placement of surgical mesh in repair of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI).

On May 16, 2011, the New England Journal of Medicine (NEJM) Study on Transvaginal Mesh Complications confirmed that the use of surgical mesh to treat pelvic organ prolapse carries the risk of serious side effects including bladder perforation and pelvic hemorrhaging.

On July 13, 2011, FDA issued an updated safety communication warning that surgical placement of transvaginal mesh to repair POP may expose patients to a greater risk of side effects than other treatment options. In addition to the increased risk of side effects, the FDA stated that vaginal mesh offers no greater clinical value or improved quality of life over other surgical methods.

On August 25, 2011, Public Citizen called on FDA to recall the vaginal mesh in response to a high number of reports linking vaginal mesh products to erosion, pain, bleeding and urinary incontinence.

Transvaginal Mesh Products & Manufacturers include:

Ethicon

  • Secure
  • Prolift
  • Prolift +M
  • Gynemesh/Gynemesh PS
  • Prosima
  • TVT
  • TVT-Obturator (TVT-O)
  • TVT-SECUR (TVT-S)
  • TVT-Exact
  • TVT-Abbrevo

C. R. Bard

  • Align
  • Avaulta Plus™ BioSynthetic Support System
  • Avaulta Solo™ Synthetic Support System
  • Faslata® Allograft
  • Pelvicol® Tissue
  • PelviSoft® Biomesh
  • Pelvitex™ Polypropylene Mesh
  • PelviLace
  • InnerLace
  • Uretex

American Medical Systems

  • SPARC®
  • Mini-Arc
  • Apogee
  • Elevate
  • Monarc
  • In-Fast
  • BioArc

Boston Scientific

  • Obtryx® Curved Single
  • Obtryx® Mesh Sling
  • Obtryx Transobturator Mid-Urethral Sling System
  • Prefyx Mid U™ Mesh Sling System
  • Prefyx PPS™ System
  • Uphold Vaginal Support System
  • Pinnacle Pelvic Floor Repair Kit
  • Advantage Transvaginal Mid-Urethral Sling System
  • Advantage Fit System
  • Solyx SIS System

Coloplast

  • 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
Cook 
  • Surgisis

Neomedic

The firm provides a monthly attorney-client privileged e-newsletter with case updates and reports to our private clients only. For additional information, or to review our public FAQS, doctors’ discussions of chronic pelvic pain and medical legal information, click on the TVM YouTube channel and click the link:  TVM :: Transvaginal Mesh Products
If you have been injured or suspect that you may have complications linked to transvaginal mesh surgery or the placement of a transvaginal mesh product, you should contact us immediately for a free medical legal review of your potential case. Please fill out the “Do I Have a Case” form or contact nurse lawyer, Carolyn St. Clair, RN, BSN, JD, by emailing carolyn@carolynstclair.com or call toll free 1-800-814-4540.