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Transvaginal Mesh Lawsuits

We are accepting Pelvic Mesh and Bladder Sling surgical revision or removal cases

2021 Update – Over $8 billion in Transvaginal Mesh verdicts and settlements occurred over the past decade. In 2019, the FDA stopped the sale of pelvic mesh to treat pelvic organ prolapse (POP), however, many manufacturers still sell Transvaginal Mesh products to treat stress urinary incontinence (SUI) in women. Thousands of women complain of suffering associated with Transvaginal Mesh devices, including:

  • chronic pelvic pain
  • urinary problems and/or incontinence
  • pain during sexual intercourse
  • recurrence of prolapsed bladder or uterus
  • infection and abscess

These symptoms have been linked to complications of the mesh surgery, including:

  • bowel, bladder, and blood vessel perforation
  • pelvic floor damage
  • pudendal nerve damage
  • mesh erosion or extrusion through the vaginal tissue
  • mesh contracture or shrinkage
  • chronic inflammation
  • fistula creation
  • internal scar tissue formation

Treatment of complications includes additional surgical procedures to revise or remove the mesh, blood transfusions, drainage of hematomas and abscesses from infection. The FDA announced many of the implants are no longer on the market and are not being sold after 2019: Urogynecologic Surgical Mesh Implants | FDA – US Food and Drug.

Contact us at 1-800-814-4540 or email carolyn@carolynstclair.com about your case and click the TVM video link to review medical legal animation, diagrams and warnings about TVM implants and litigation. Failed Transvaginal Mesh Injury Lawsuit Podcast with Howard L. Nations.

Pelvic Mesh Verdicts and Settlements

The plaintiffs have won 27 trials, the defendants have won 7 and thousands have been resolved. The verdicts, settlements, manufacturers, products, and jurisdictions include:

  1. 1/20: $0 – Salinero v. Ethicon/JJ (Artisyn Pelvic Mesh) FL
  2. 6/19: $500,000 – Dunfee v. Ethicon/JJ (Prolift Pelvic Mesh) PA
  3. 5/19: $80+ million – Mesigian v. Ethicon/JJ (Prolift Pelvic Mesh) PA
  4. 4/19: $120 million – McFarland v. Ethicon/JJ (TVT-O Sling) PA
  5. 1/19: $41 million – Emmett v. Ethicon/JJ (Prolift Pelvic Mesh & TVT-O Sling) PA
  6. 4/18: $68 million – McGinnis v. Bard (Solo Pelvic Mesh & Align Sling)  NJ
  7. 3/18: $35 million – Kaiser v. Ethicon/JJ (Prolift Pelvic Mesh) IN
  8. 9/17: $57.1 million – Ebaugh v. Ethicon/JJ (TVT Secur Sling) PA
  9. 5/17: $2.16 million – Betz v. Ethicon (Prolift Pelvic Mesh)  PA
  10. 4/17: $20.0 million – Engleman v. Ethicon/JJ (TVT Secur Sling) – PA
  11. 2/16: $13.5 – Carlino v. Ethicon/JJ (TVT Sling)  PA
  12. 2/16: $0 – Sherrer v. Boston Scientific (Solyx Sling & Bard Align Sling) MO
  13. 12/15: $12.5 million – Hammons v. Ethicon/JJ (Prolift Pelvic Mesh) PA
  14. 10/15: $0 – Martha Carlson v. Boston Scientific (Uphold Pelvic Mesh) NC
  15. 10/15: $0 – Carol Cavness v. Ethicon/JJ (Prosima Pelvic Mesh) TX
  16. 5/15: $100 million – Deborah Barda v. Boston Scientific (Pinnacle Pelvic Mesh, Advantage Fit Sling) DL
  17. 3/15: $5.7 million – Coleen Perry – Ethicon/JJ (Abbrevo Sling) CA
  18. 5/15: Settled – Sanchez v. Boston Scientific (Pinnacle Pelvic Mesh) CA
  19. 3/15: Settled  – Bellew v. Ethicon (Prolift Pelvic Mesh) MDL
  20. 2/15: Settled – Wise v. Bard (Avaulta, Avaulta Plus Pelvic Mesh) MDL
  21. 11/14: $6.7+ million – Amal Eghnayem – Boston Scientific (Pinnacle Pelvic Mesh) MDL FL
  22. 11/14: $6.7+ million – Margarita Dotres – Boston Scientific (Pinnacle Pelvic Mesh) MDL FL
  23. 11/14: $6.7+ million – Mania Nunez – Boston Scientific (Pinnacle Pelvic Mesh) MDL FL
  24. 11/14: $6.5+ million – Juana Betancourt – Boston Scientific (Pinnacle Pelvic Mesh) MDL FL
  25. 11/14: $5.25 million – Jeanie Blankenship – Boston Scientific (Obtryx Sling) MDL
  26. 11/14: $4.75 million – Chris Wilson – Boston Scientific (Obtryx Sling) MDL
  27. 11/14: $4.25 million – Carol Campbell – Boston Scientific (Obtryx Sling)  MDL
  28. 11/14: $4.25 million – Jacquelyn Tyree – Boston Scientific (Obtryx Sling) MDL
  29. 9/14: $73.465 million – Martha Salazar – Boston Scientific (Obtryx) TX
  30. 9/14: $3.27 million – Jo Huskey – Ethicon/JJ (TVT-O Sling) MDL WV
  31. 8/14: $0 – Maria Cardenas – Boston Scientific (Obtryx Sling) MA
  32. 7/14: $0 – Diane Albright – Boston Scientific (Pinnacle Pelvic Mesh) MA
  33. 4/14: $1.2 million – Linda Batiste – Ethicon/JJ (TVT-O Sling) TX
  34. 2/14: $0 – Carolyn Lewis – Ethicon/JJ (TVT-O Sling) MDL
  35. 8/13: $2 million – Donna Cisson – C.R. Bard (Avaulta Pelvic Mesh) MDL
  36. 2/13: $11.11 million – Linda Gross – Ethicon/JJ (Prolift Pelvic Mesh) NJ
  37. 7/12: $5.5 million – Christine Scott – C.R. Bard (Avaulta Plus Pelvic Mesh) CA

$344 Million Judgment

Johnson & Johnson and its subsidiary, Ethicon, must pay the state attorney general approximately $344 million for deceptively marketing their transvaginal mesh devices as safe. On January 20, 2020, San Diego County Superior Court Judge Eddie Sturgen issued the $343.99 million judgment following a lengthy trial that began on July 15.

$117 Million Settlement

Johnson & Johnson and Ethicon Inc. agreed to pay nearly $117 million to 41 states and the District of Columbia to settle allegations that they touted the benefits of their transvaginal surgical mesh devices while concealing the risks. The October 18, 2019 settlement requires the companies to fully disclose the device’s risks and accurate information on promotional material and “information for use” package inserts.

$500,000 Mesh Verdict

$500,000 was awarded to transvaginal mesh plaintiff, Linda Dunfee, by a jury in the Philadelphia County Court of Common Pleas on June 28, 2019. The jury found that design defects in Ethicon’s Prolift mesh resulted in Ms. Dunfee’s pain and suffering. The jury did not award any punitive damages against Ethicon/Johnson and Johnson.

$80+ Million Mesh Verdict

$80.025 million was awarded to transvaginal mesh plaintiffs Patricia and George Mesigian on May 19, 2019. Patricia was implanted with Prolift mesh in 2008 to treat organ prolapse, but the mesh eroded causing pain, infections, inflammation and scar tissue which required several revision surgeries. The award included $50 million in punitive damages and $30 million in compensatory damages.

$120 Million Mesh Verdict

$120 Million was awarded to a transvaginal mesh plaintiff on April 24, 2019. The jury found that Ethicon, the Johnson and Johnson subsidiary, negligently designed the pelvic mesh implant forcing Susan McFarland to suffer with incontinence and chronic pain that prevented her from having sex with her husband for over ten years. The TVT-O implanted in 2008 sawed through the soft tissue in Susan’s pelvis and was exposed in her vagina. She was eventually forced to undergo a second surgery to remove a portion of the implant. This is the second trial for the McFarland couple as the first jury deadlocked in September 2018, resulting in a retrial.

 $68 Million Mesh Verdict

A New Jersey state jury rendered a verdict against C.R. Bard Inc.in the total amount of $68 million in damages on Friday the 13th of April, 2018. The breakdown calculations of the award include $23 million in compensatory damages to plaintiff Mary McGinnis, $10 million to her husband, Thomas McGinnis, and $35 million in punitive damages. The New Jersey jury heard evidence that the manufacturer knew that two of its pelvic mesh products implanted in Mary were unsafe and failed to warn doctors about potential risks related to devices that caused overwhelming and debilitating pain and suffering. Bard vows to appeal the verdict.

$41 Million Mesh Verdict

$41 Million was awarded to a transvaginal mesh plaintiff by a jury on January 31, 2019. The Philadelphia jury found against Johnson & Johnson’s subsidiary, Ethicon Inc., and rendered a $41 million verdict. The jury found that defects in the plaintiff’s pelvic mesh implant manufactured by JJ/Ethicon left Suzanne Emmett with permanent injuries after three products sawed into her vagina. The three pelvic mesh devices were implanted after she suffered organ prolapse. The mesh repeatedly eroded into her vagina, leaving her with urinary incontinence, painful bladder contractions and pain during sex. Suzanne underwent nine surgical procedures and over 40 nerve treatments, including injections. Mr. Emmett, Suzanne’s husband’s had evidence that his privates were cut like a piece of barbed wire during sex.

 $35 Million Mesh Verdict

$35 million was awarded to Barbara Kaiser by a Gary, Indiana jury consisting of $10 million in compensatory damages and $25 million in punitives. Ms. Kaiser was implanted with a Prolift mesh in 2009 and suffered with pain and underwent a surgical revision of the implant. This follows $57.1 million awarded against Johnson & Johnson and Ethicon to Ella Ebaugh, who was implanted with TVT-Secur transvaginal mesh that eroded through her urethra, caused her internal injuries and permanently damaged her urinary system leaving her incontinent. The jury verdict included $7.1 million in compensatory damages and $50 million in punitive damages. The Philadelphia Court of Common Pleas verdict was delivered September 7, 2017, marking the fifth TVM verdict against the mesh manufacturers.

$20 million was awarded to a woman who suffered after multiple surgeries to remove a TVT-Secur mesh implant. On April 28, 2017, the Philadelphia Common Pleas Court jury awarded  $2.5 in compensatory damages and $17.5 million in punitive damages. Plaintiff, Peggy Engleman’s mesh failed within a month of implantation causing pain as the mesh eroded into her tissues leaving shreds of mesh in her body. On May 26, 2017, Sharon Beltz was awarded $2.16 million for injuries caused by Ethicon’s Prolift implanted in 2006. Johnson and Johnson vows to appeal the cases to a higher court.

Pelvic Mesh Ordered Off the Market

On April 16, 2019, the FDA ordered the manufacturers of pelvic synthetic surgical mesh products to stop selling and distributing their products in the United States immediately. Reported side effects include permanent incontinence, severe discomfort and an inability to have sex.  The mesh is made from polypropylene, which is the same material as fishing line. The FDA said it determined that “the manufacturers, Boston Scientific and Coloplast, have not demonstrated a reasonable assurance of safety and effectiveness for these devices.”   Additional information for patients and health care providers about the use of surgical mesh for transvaginal pelvic organ prolapse is provided in the links.

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
  • Perigee
  • 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
  • Altis Sling
  • 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

Verdicts by Product Manufacturer

The MDL’s were dismantled in 2018. Cases in each court have been resolved, dismissed or been tried to a jury. Past verdicts and settlements include:

MDL No. 2327 | In Re Ethicon, Inc., Pelvic Repair System Products Liability Litigation – Past verdicts and settlements include:

  1. 1/20: $0 – Salinero v. Ethicon/JJ (Artisyn Pelvic Mesh) FL
  2. 6/19: $500,000 – Dunfee v. Ethicon/JJ (Prolift Pelvic Mesh) PA
  3. 5/19: $80+ million – Mesigian v. Ethicon/JJ (Prolift Pelvic Mesh) PA
  4. 4/19: $120 million – McFarland v. Ethicon/JJ (TVT-O Sling) PA
  5. 1/19: $41 million – Emmett v. Ethicon/JJ (Prolift Pelvic Mesh & TVT-O Sling) PA
  6. 3/18: $35 million – Kaiser v. Ethicon/JJ (Prolift Pelvic Mesh) IN
  7. 9/17: $57.1 million – Ebaugh v. Ethicon/JJ (TVT Secur Sling) PA
  8. 5/17: $2.16 million – Betz v. Ethicon (Prolift Pelvic Mesh)  PA
  9. 4/17: $20.0 million – Engleman v. Ethicon/JJ (TVT Secur Sling) – PA
  10. 2/16: $13.5 – Carlino v. Ethicon/JJ (TVT Sling)  PA
  11. 12/15: $12.5 million – Hammons v. Ethicon/JJ (Prolift Pelvic Mesh) PA
  12. 10/15: $0 – Carol Cavness v. Ethicon/JJ (Prosima Pelvic Mesh) TX
  13. 3/15: $5.7 million – Coleen Perry – Ethicon/JJ (Abbrevo Sling) CA
  14. 3/15: Settled  – Bellew v. Ethicon (Prolift Pelvic Mesh) MDL
  15. 9/14: $3.27 million – Jo Huskey – Ethicon/JJ (TVT-O Sling) MDL WV
  16. 4/14: $1.2 million – Linda Batiste – Ethicon/JJ (TVT-O Sling) TX
  17. 2/14: $0 – Carolyn Lewis – Ethicon/JJ (TVT-O Sling) MDL
  18. 2/13: $11.11 million – Linda Gross – Ethicon/JJ (Prolift Pelvic Mesh) NJ
  19. 1/20: $0 – Salinero v. Ethicon/JJ (Artisyn Pelvic Mesh) FL
  20. 6/19: $500,000 – Dunfee v. Ethicon/JJ (Prolift Pelvic Mesh) PA
  21. 5/19: $80+ million – Mesigian v. Ethicon/JJ (Prolift Pelvic Mesh) PA
  22. 4/19: $120 million – McFarland v. Ethicon/JJ (TVT-O Sling) PA
  23. 1/19: $41 million – Emmett v. Ethicon/JJ (Prolift Pelvic Mesh & TVT-O Sling) PA

MDL No. 2325 | In Re American Medical Systems, Inc., Pelvic Repair System Products Liability Litigation – Settlement announced for all remaining mesh lawsuits in the MDL.

MDL No. 2187 | In Re C. R. Bard, Inc., Pelvic Repair System Products Liability Litigation –    Past verdicts and settlements include:

  1. 4/18: $68 million – McGinnis v. Bard (Solo Pelvic Mesh & Align Sling)  NJ
  2. 2/15: Settled – Wise v. Bard (Avaulta, Avaulta Plus Pelvic Mesh) MDL
  3. 8/13: $2 million – Donna Cisson – C.R. Bard (Avaulta Pelvic Mesh) MDL
  4. 7/12: $5.5 million – Christine Scott – C.R. Bard (Avaulta Plus Pelvic Mesh) CA

MDL No. 2326 | In Re Boston Scientific Corp. Pelvic Repair System Products Liability Litigation – Past verdicts include:

  1. 2/16: $0 – Sherrer v. Boston Scientific (Solyx Sling & Bard Align Sling) MO
  2. 10/15: $0 – Martha Carlson v. Boston Scientific (Uphold Pelvic Mesh) NC
  3. 5/15: $100 million – Deborah Barda v. Boston Scientific (Pinnacle Pelvic Mesh, Advantage Fit Sling) DL
  4. 5/15: Settled – Sanchez v. Boston Scientific (Pinnacle Pelvic Mesh) CA
  5. 11/14: $6.7+ million – Amal Eghnayem – Boston Scientific (Pinnacle Pelvic Mesh) MDL FL
  6. 11/14: $6.7+ million – Margarita Dotres – Boston Scientific (Pinnacle Pelvic Mesh) MDL FL
  7. 11/14: $6.7+ million – Mania Nunez – Boston Scientific (Pinnacle Pelvic Mesh) MDL FL
  8. 11/14: $6.5+ million – Juana Betancourt – Boston Scientific (Pinnacle Pelvic Mesh) MDL FL
  9. 11/14: $5.25 million – Jeanie Blankenship – Boston Scientific (Obtryx Sling) MDL
  10. 11/14: $4.75 million – Chris Wilson – Boston Scientific (Obtryx Sling) MDL
  11. 11/14: $4.25 million – Carol Campbell – Boston Scientific (Obtryx Sling)  MDL
  12. 11/14: $4.25 million – Jacquelyn Tyree – Boston Scientific (Obtryx Sling) MDL
  13. 9/14: $73.465 million – Martha Salazar – Boston Scientific (Obtryx) TX
  14. 8/14: $0 – Maria Cardenas – Boston Scientific (Obtryx Sling) MA
  15. 7/14: $0 – Diane Albright – Boston Scientific (Pinnacle Pelvic Mesh) MA

MDL No. 2440 | In Re Cook Medical, Inc., Pelvic Repair System Products Liability Litigation – No trials were scheduled. The following cases were dismissed: Ailey v. Cook Inc., Watkins v. Cook Inc., et al. Hovey v. Cook Inc., et al.

MDL No. 2387 | In Re Coloplast Corp. Pelvic Support Systems Products Liability Litigation – . There were no bellwether trials scheduled and the judge conducted settlement conferences.

MDL No. 2511 | In Re Neomedic Pelvic Repair System Products Liability Litigation – There were no bellwether trials scheduled. Settlement Program entered 11/2015.

  History and FDA 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.

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.

September 2011: FDA convened a public meeting of the Obstetrics and Gynecology Devices Panel to discuss the benefits and risks of this use. Subsequently, the FDA issued 131 orders to conduct post market surveillance studies (“522 orders”) to 34 manufacturers of surgical mesh for transvaginal repair of POP. Most manufacturers elected to stop marketing surgical meshfor transvaginal repair of POP after receiving their 522 orders.

January 2016: The FDA completed its reclassification of surgical mesh for transvaginal repair of POP into the highest risk class of devices (class III), which requires premarket approval (PMA) applications, the agency’s most stringent device review pathway, in order to stay on the market.

July 5, 2018: This was the deadline for applications to be filed for premarket approval for any surgical mesh marketed for transvaginal POP repair. Manufacturers that did not file PMAs by this deadline were required to withdraw their products from the market. Those that did file PMAs were allowed to keep their mesh products on the market while the FDA reviewed their PMAs.

February 12, 2019: The FDA convened an advisory committee meeting to share the available evidence and seek expert opinions on how to evaluate the risks and benefits of these devices. The committee evaluated mesh placed transvaginally in the anterior vaginal compartment, as well as identifying the appropriate patient population and physician training needed for these devices. Boston Scientific filed two PMAs for its devices, the Uphold LITE Vaginal Support System and the Xenform Soft Tissue Repair System. Coloplast filed a PMA for its device, Restorelle DirectFix Anterior.

In February 2019, the FDA convened an advisory panel of experts that recommended that to support a favorable benefit-risk profile, the effectiveness of surgical mesh for transvaginal repair of POP should be superior to native tissue repair at 36 months. The FDA agreed with these recommendations, and because such data were not provided by manufacturers in their PMAs, the FDA decided not to approve Pelvic Organ Prolapse devices. Even though these products can no longer be used in patients moving forward, Boston Scientific and Coloplast are required to continue follow up of the subjects already enrolled in their 522 studies.

Contact Us Now

Call us at 1-800-814-4540 or carolyn@carolynstclair.com about your case. Our consultations are free and confidential. There are time limits in each state and hospitals destroy medical records after a certain time frame, so contact us now to preserve your rights.

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