Transvaginal Mesh Lawsuits
November 20, 2018 – Update on the FDA’s actions to strengthen requirements for surgical mesh intended for transvaginal pelvic organ prolapse (POP) repair
The FDA is taking further steps to assure women’s health and access to safe and effective medical devices. The FDA’s efforts on urogynecologic surgical mesh have focused on identifying benefit-risk concerns related to some of these devices, and strengthening the FDA’s regulatory oversight to protect patients, while enabling those who need these devices to benefit from them. Providing patients with access to the safest possible medical devices on the market to meet their health care needs remains a top FDA priority.
In 2011, the FDA issued an FDA Safety Communication, which identified concerns about the use of surgical mesh for transvaginal repair of pelvic organ prolapse , and 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 postmarket surveillance studies (“522 orders”) to 34 manufacturers of surgical mesh for transvaginal repair of pelvic organ prolapse. Most manufacturers elected to stop marketing surgical mesh for transvaginal repair of pelvic organ prolapse after receiving their 522 orders. Currently, there are four ongoing 522 studies for five devices.
On January 5, 2016, the FDA reclassified surgical mesh for transvaginal repair of pelvic organ prolapse into class III, which require premarket approval (PMA) applications, the agency’s most stringent device review pathway. The FDA mandated that premarket approval applications be filed by July 5, 2018 for any surgical mesh marketed for transvaginal pelvic organ prolapse repair. As a result of the FDA’s actions, all manufacturers ceased marketing of surgical mesh intended for transvaginal repair of posterior compartment prolapse (rectocele). In addition, only three surgical mesh products intended for transvaginal repair of anterior compartment prolapse (cystocele) remain on the market while FDA reviews their premarket approval applications.
On February 12, 2019, the FDA plans to convene an advisory committee meeting to share the available evidence and seek expert opinion about the safety and effectiveness of surgical mesh intended for transvaginal POP repair. This meeting will also provide the public, including patients, an opportunity to comment.
$68 Million Verdict Against Bard
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 2018. The breakdown of the award includes $23 million in compensatory damages to plaintiff Mary McGinnis, $10 million to her husband, Thomas McGinnis, and $35 million in punitive damages. The jury heard evidence that the manufacturer knew that two of Bard’s pelvic mesh products (Avaulta Solo and Align TO) were unsafe and failed to warn doctors about potential risks related to devices that caused the plaintiff’s overwhelming and debilitating pain and suffering. Read about Bard’s hernia mesh lawsuits pending here: Hernia Mesh Lawsuit
$35 Million Verdict Against Ethicon
$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 Ethicon mesh manufacturers.
Sixty Minutes reported the controversy over Boston Scientific utilizing Chinese imported product labeled as Marlex. $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 both cases to a higher court.
Transvaginal mesh bellwether trials and settlements update:
MDL No. 2327 | In Re Ethicon, Inc., Pelvic Repair System Products Liability Litigation – Cases are being prepared for trials, dismissals or remands. Total Cases: 40,290 Total Closed: 13,056 Past verdicts and settlements include:
- Mullins, et al. v. Ethicon, Inc., et al., 2:12-cv-02952 (37 TVTs) trial continued
- Edwards v. Ethicon, Inc., et al., 2:12-cv-09972- Dismissed
- Dianne Bellew v. Ethicon, Inc. (Prolift) settled March 6, 2015
- 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. 2325 | In Re American Medical Systems, Inc., Pelvic Repair System Products Liability Litigation – Settlement announced for all remaining mesh lawsuits in the MDL. Total Cases: 21,251 Total Closed: 19,991
MDL No. 2187 | In Re C. R. Bard, Inc., Pelvic Repair System Products Liability Litigation– Cases are being prepared for trials, dismissals or remands. The court ordered Mandatory Settlement Conferences for unsettled Covidien LP, Sofradim and TSL plaintiffs. Total Cases: 15,694 Total Closed: 12,029 Past verdicts and settlements include:
- Wise, et al. v. C. R. Bard, Inc. – Settled
- 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 – Settlements in process with no trials scheduled. Total Cases: 25,581 Total Closed: 16,303
Past verdicts include:
- Jeanie Blankenship – $4.25 million + $1 million punitive damages
- Chris Wilson – $3.75 million + $1 million punitive damages
- Carol Campbell – $3.25 million + $1 million punitive damages
- Jacquelyn Tyree – $3.25 million + $1 million punitive damages
- Juana Betancourt – $6.5 + million
- Mania Nunez – $6.7 + million; and
- Margarita Dotres – $6.7 + million;
- Amal Eghnayem – $6.7 + million
MDL No. 2440 | In Re Cook Medical, Inc., Pelvic Repair System Products Liability Litigation – No trials have been scheduled. Total Cases: 640 Total Closed: 571
MDL No. 2387 | In Re Coloplast Corp. Pelvic Support Systems Products Liability Litigation – . There are no bellwether trials scheduled. Total Cases: 2678 Total Closed: 2536
MDL No. 2511 | In Re Neomedic Pelvic Repair System Products Liability Litigation – There are no bellwether trials scheduled. Settlement Program entered 11/2015. Total Cases: 137 Total Closed: 125
Transvaginal Mesh Verdicts
A chronology of the verdicts, settlements, manufacturers, products, and jurisdictions 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
- 11/14: $6.7+ million – Margarita Dotres – Boston Scientific Pinnacle – MDL FL
- 11/14: $6.7+ million – Mania Nunez – Boston Scientific Pinnacle – MDL FL
- 11/14: $6.5+ million – Juana Betancourt – Boston Scientific Pinnacle – MDL FL
- 11/14: $5.25 million – Jeanie Blankenship – Boston Scientific Obtryx – MDL WV
- 11/14: $4.75 million – Chris Wilson – Boston Scientific Obtryx – MDL
- 11/14: $4.25 million – Carol Campbell – Boston Scientific Obtryx – MDL
- 11/14: $4.25 million – Jacquelyn Tyree – Boston Scientific Obtryx – MDL
- 2/15: Settled – Wise v. Bard in the MDL
- 3/15: Settled – Bellew v. Ethicon (Prolift) in the MDL;
- 5/15: Settled – Sanchez v. Boston Scientific (Pinnacle) – CA
- 3/15: $5.7 million – Coleen Perry – Ethicon/JJ Abbrevo sling – CA
- 5/15: $100 million – Deborah Barda v. Boston Scientific Pinnacle and Advantage Fit – DL
- 10/15: $0 – Carol Cavness v. Ethicon/JJ Prosima – TX
- 10/15: $0 – Martha Carlson v. Boston Scientific Uphold – NC
- 12/15: $12.5 million – Hammons v. Ethicon/JJ (Prolift) – PA
- 2/16: $0 – Sherrer v. Boston Scientific Solyx and Bard Align – MO
- 2/16: $13.5 – Carlino v. Ethicon/JJ (TVT) – PA
- 4/17: $20.0 million – Engleman v. Ethicon/JJ (TVT Secur) – PA
- 5/17: $2.16 million – Betz v. Ethicon/Prolift – PA
- 9/17: $57.1 million – Ebaugh v. Ethicon/JJ (TVT-Secur) – PA
- 2/18: $68 million – McGinnis v. Bard – (Avaulta Solo, Align TO) NJ
- 3/18: $35 million – v. Kaiser v. Ethicon/JJ (Prolift) – IN
Other TVM Verdicts and Trials
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.
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:
- Amal Eghnayem – $6.7 + million;
- Margarita Dotres – $6.7 + million;
- Mania Nunez – $6.7 + million; and
- 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:
- Jeanie Blankenship – $4.25 million + $1 million punitive damages;
- Chris Wilson – $3.75 million + $1 million punitive damages;
- Carol Campbell – $3.25 million + $1 million punitive damages;
- 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
- infection and abscess
- 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 Meshin the United States because the FDA required additional clinical trials and testing.
On June 4, 2012: Johnson and Johnson/Ethicon withdrewfour mesh products from the US Market, including its controversialGynecare 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
- Prolift +M
- Gynemesh/Gynemesh PS
- TVT-Obturator (TVT-O)
- TVT-SECUR (TVT-S)
C. R. Bard
- Avaulta Plus™ BioSynthetic Support System
- Avaulta Solo™ Synthetic Support System
- Faslata® Allograft
- Pelvicol® Tissue
- PelviSoft® Biomesh
- Pelvitex™ Polypropylene Mesh
American Medical Systems
- 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
- 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