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Transvaginal Mesh Lawsuits

$100 Million Jury Verdict Against Boston Scientific

$100 Million was awarded to the plaintiffs in Deborah Barba v. Boston Scientific by a Delaware jury on May 28, 2015.  Ms. Barba had been implanted with Boston Scientific’s Pinnacle Pelvic Floor Repair Kit as well as an Advantage Fit mid-urethral sling system and sustained significatn injuries. The award was reduced to $10 Million by Judge Mary Johnston after trial. 

Please note: At this late date in the litigation, we review only mesh/sling removal or revision cases. Contact other counsel if your mesh/sling has not been removed or revised or is not scheduled for removal or revision surgery.

On February 10, 2016, $13.5 million was awarded by a Philadelphia jury in Carlino v. Ethicon. $10 million of that award was for punitive damages. The plaintiff suffered through three TVT sling revision and removal mesh surgeries following her Ethicon/Johnson and Johnson implant.

This follows a $12.5 million jury verdict in a transvaginal mesh lawsuit against Johnson and Johnson’s Ethicon division on December 22, 2015. A Philadephia jury found that Patricia Hammons suffered injuries from a Prolift pelvic mesh implant, which was removed from the medical device market in 2012. The $12.5 million award included $7 million in punitive damages as the jury heard evidence of Ethicon’s document destruction. 

On February 2, 2016, a Kansas City, Missouri jury awarded nothing to the plaintiff in a Boston Scientific Solyx and C.R. Bard Align case. On October 16th,  2015, the jury awarded nothing to the plaintiff in Martha Carlson v. Boston Scientific in Statesville, North Carolina. On October 5th, 2015, the jury awarded nothing for the plaintiff in Carol Cavness v. Ethicon/ Johnson and Johnson in Dallas, Texas.  

As of August 3rd, 2016, eighteen (18) transvaginal mesh plaintiffs have won trials and the defendants have won six (6). Following the failed status conferences, TVM trials moved forward, resulting in two plaintiffs’ verdicts ranging from $100 Million to $5.7 Million and numerous confidential settlements.  Boston Scientific, Coloplast, AMS and Bard have begun offering settlements.   Judge Goodwin has ordered all MDL counsel to appear for status conferences September 13 and 14, 2016. 

Transvaginal Mesh Verdicts 

A chronology of the eighteen (18) plaintiffs’ verdicts and six (6) defense verdicts, settlements, manufacturers, products, and jurisdictions follows:

  1. 7/12: $5.5 million – Christine Scott – C.R. Bard Avaulta Plus –  CA
  2. 2/13: $11.11 million – Linda Gross – Ethicon/JJ Prolift – NJ
  3. 8/13: $2 million – Donna Cisson – C.R. Bard Avaulta – MDL WV
  4. 2/14: $0 – Carolyn Lewis – Ethicon/JJ TVT-O – MDL WV
  5. 4/14: $1.2 million – Linda Batiste – Ethicon/JJ TVT-O  – TX
  6. 7/14: $0 – Diane Albright – Boston Scientific Pinnacle – MA
  7. 8/14: $0 – Maria Cardenas – Boston Scientific Obtryx – MA
  8. 9/14: $3.27 million – Jo Huskey – Ethicon/JJ TVT-O – MDL WV
  9. 9/14: $73.465 million – Martha Salazar – Boston Scientific Obtryx – TX
  10. 11/14: $6.7+ million – Amal Eghnayem – Boston Scientific Pinnacle – MDL FL
  11. 11/14: $6.7+ million – Margarita Dotres – Boston Scientific Pinnacle – MDL FL
  12. 11/14: $6.7+ million – Mania Nunez – Boston Scientific Pinnacle – MDL FL
  13. 11/14: $6.5+ million – Juana Betancourt – Boston Scientific Pinnacle – MDL FL
  14. 11/14: $5.25 million – Jeanie Blankenship – Boston Scientific Obtryx –  MDL WV
  15. 11/14: $4.75 million – Chris Wilson – Boston Scientific Obtryx – MDL
  16. 11/14: $4.25 million – Carol Campbell – Boston Scientific Obtryx – MDL
  17. 11/14: $4.25 million – Jacquelyn Tyree – Boston Scientific Obtryx – MDL
  18. 2/15: Settled – Wise v. Bard in the MDL
  19. 3/15: Settled  – Bellew v. Ethicon (Prolift) in the MDL;
  20. 5/15: Settled – Sanchez v. Boston Scientific (Pinnacle) – CA
  21. 3/15: $5.7 million – Coleen Perry – Ethicon/JJ Abbrevo sling – CA
  22. 5/15: $100 million – Deborah Barda v. Boston Scientific Pinnacle and Advantage Fit – DL
  23. 10/15: $0 – Carol Cavness v. Ethicon/JJ Prosima –  TX
  24. 10/15: $0 – Martha Carlson v. Boston Scientific Uphold – NC
  25. 12/15: $12.5 million – Hammons v. Ethicon/JJ (Prolift) –  PA
  26. 2/16: $0 – Sherrer v. Boston Scientific Solyx and Bard Align – MO
  27. 2/16: $13.5 – Carlino v. Ethicon/JJ (TVT)  – PA

TVM MDL Status 

In multidistrict litigation,  exemplar cases, called bellwethers, are chosen to be tried by the lawyers and Judge. Thousands of other cases remain on the dockets while the bellwether cases are tried. The awards in the bellwether trials provide a range of settlement values for the remaining cases on the dockets. The bellwether trial schedule is updated as follows:

MDL No. 2325 | In Re American Medical Systems, Inc., Pelvic Repair System Products Liability Litigation – 20,230 cases listed on file with 11,456. Settlements in process with no trials scheduled.

MDL No. 2327 | In Re Ethicon, Inc., Pelvic Repair System Products Liability Litigation – 33,874 cases listed on file with 1345 closed. MDL trial scheduled and verdicts include:

  1. Mullins, et al. v. Ethicon, Inc., et al., 2:12-cv-02952 (37 TVTs) trial continued
  2. Edwards v. Ethicon, Inc., et al., 2:12-cv-09972-  Dismissed
  3. Dianne Bellew v. Ethicon, Inc. (Prolift) settled March 6, 2015
  4. Carolyn Lewis v. Ethicon, et al. Defense Judgment
  5. Huskey v. Ethicon, et al. $3.27 Million Verdict for Plaintiffs
  6. Brenda Lehrer v. Ethicon, Inc., et al. (Prolift) Dismissed

MDL No. 2187 | In Re C. R. Bard, Inc., Pelvic Repair System Products Liability Litigation– 13,778 cases on file with 1886 closed.  Settlements in process with no MDL trials scheduled.

  1. Wise, et al. v. C. R. Bard, Inc. – Settled
  2. Donna Cisson v. Bard, Inc.  – $2 Million Verdict
  3. Wanda Queen v. Bard, Inc. 2:11-cv-00012  – Settled
  4. Carolyn Jones v. Bard, Inc. 2:11-cv-00114 – Settled

MDL No. 2326 | In Re Boston Scientific Corp. Pelvic Repair System Products Liability Litigation – 21,692 cases listed on file with 1637 closed. Settlements in process with no trials scheduled.

  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
  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. 2440 | In Re Cook Medical, Inc., Pelvic Repair System Products Liability Litigation – 508 cases listed on file with 112 closed. No trials have been scheduled. The following cases were dismissed:

  • Ailey v. Cook Inc., et al. 2:13-cv-18888
  • Watkins v. Cook Inc., et al. 2:13-cv-20370
  • Hovey v. Cook Inc., et al. 2:13-cv-18900

MDL No. 2387 | In Re Coloplast Corp. Pelvic Support Systems Products Liability Litigation – 2489 cases listed on file with 1144 closed. There are no bellwether trials scheduled and the judge is conducting settlement conferences. 

MDL No. 2511 | In Re Neomedic Pelvic Repair System Products Liability Litigation – 135 cases listed on file with 8 closed. There are no bellwether trials scheduled. Settlement Program entered November 2015.

Verdicts and Settlements Against Ethicon

A  California jury awarded $5.7 million to Coleen Perry, who was implanted with an Abbrevo sling device. Ms. Perry experienced pain after surgery, but the sling could only be partially surgically removed  because the mesh had grown into the tissues. The jury unanimously awarded $5 million in punitive damages finding Ethicon acted with malice. 

Trial began March 2, 2015 in Bellew v. Ethicon in the MDL and settled March 6, 2015 for an undisclosed amount. This case involved removal of a Prolift mesh, a product which had been taken off the medical device market. 

Bard Bellwether Case Settles Before Trial

Wise v. Bard, the bellwether case set for trial February 18, 2015, was settled right before trial for a confidential amount.  On February 12, 2015,  Judge Goodwin appointed Ellen Reisman as Special Master to facilitate settlement negotiations in the Bard MDL. Christine Scott, the first Bard Avaulta Plus plaintiff who endured nine mesh revision surgeries stated, “Thank God, we can finally get the word out to women.”

$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;
  4. Jacquelyn Tyree  – $3.25 million + $1 million punitive damages

Transvaginal Mesh Adverse Events

Click the TVM video link which contains medical legal animation, diagrams and warnings about TVM implants and the transvaginal mesh litigation. Failed Transvaginal Mesh Injury Lawsuit Podcast with Howard L. Nations

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 

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

Transvaginal Mesh Litigation Update Contact Information 

We can’t help if you don’t call. As trial lawyers, we provide a monthly attorney-client privileged e-newsletter with case updates and reports to our private clients only. We cannot give legal advice if you are already represented by a law firm. For additional information on the upcoming TVM trial schedule, to review our FAQS, doctors’ discussions of chronic pelvic pain and medical legal information, and you are not represented by a law firm, fill out the “Do I Have a Case” form or contact nurse lawyer, Carolyn St. Clair, RN, BSN, JD, by email at carolyn@carolynstclair.com or call 1-800-814-4540.
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