Transvaginal Mesh Lawsuits 2024

$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 Ethicon 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.

$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 implants, Ethicon Prolift and TVT-O, left Suzanne Emmett with permanent injuries after three products sawed into her vagina, leaving her with urinary incontinence, painful bladder contractions and pain during sex. Suzanne underwent nine (9) surgical procedures, 40+ nerve treatments, including injections. Suzanne’s husband’s had evidence that his privates were cut like barbed wire during relations.

$68 Million Mesh Verdict

$68 million was awarded to Mary McGinnis and her husband  by a New Jersey jury consisting of: $33 million in compensatory damages for pain and suffering, medical bills, and other damages; $35 million in punitive damages to punish C.R. Bard for failing to adequately warn about side effects and selling two defective pelvic mesh implants. Mary McGinnis was implanted with two Bard pelvic mesh in March 2009 — Avaulta Solo mesh and Align Transobturator, which had both been pulled off the market by 2016. She suffered chronic pain, treatment for serious complications for over a decade, and incurred large medical bills to treat her numerous injuries.

$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 an Ethicon Prolift mesh in 2009 and suffered with pain and complications for years, then underwent a surgical revision of the implant.

$57 Million Mesh Verdict

$57.1 million was awarded against Transvaginal Mesh manufacturer, Johnson & Johnson and Ethicon, to Ella Ebaugh, who was implanted with an Ethicon 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 Mesh Verdict

$20 million was awarded to Peggy Engleman by a Pennsylvania jury consisting of $2.5 in compensatory damages and $17.5 million in punitive damages. Peggy suffered with multiple surgeries to remove an Ethicon TVT-Secur sling, which failed within a month of implantation causing pain as the mesh eroded into her tissues leaving shreds of mesh in her body. On April 28, 2017, the Philadelphia Common Pleas Court jury awarded  the verdict.

$2.16 Million Mesh Verdict

$2.16 million was awarded to Sharon Beltz by a Philadelphia, Pennsylvania jury for injuries caused by Ethicon’s Prolift mesh implanted in 2006. Sharon suffered with chronic severe pain, incontinence, retention, lower flank pain, urinary tract infections, and severe pain with intercourse and incurred volumes of itemized medical bills.

$13.5 Million Mesh Verdict

$13.5 million was awarded by a Philadelphia jury to Sharon Carlino and her husband for injuries caused by her Ethicon TVT sling and three additional surgeries due to complications.The verdict rendered in February 2016, consisted of $3.25 compensatory, $250k to Sharon’s husband, Charles, and $10 million punitive damages. The verdict was appealed by Ethicon and finally affirmed by the Superior Court in April 2019.

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.” The statement adds that if patients have experienced no problems with the mesh, no action needs to be taken to remove the 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.

TVM MDL Dismantled

The MDL has been  dismantled, with cases being transferred or remanded to other courts for trials, mediation or dismissals as follows:

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

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

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

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

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

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

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

History of Transvaginal Mesh Bellwether Trials and Settlements:

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

• Mullins, et al. v. Ethicon, Inc., et al., 2:12-cv-02952 (37 TVTs) Settled
• 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.

MDL No. 2187 | In Re C. R. Bard, Inc., Pelvic Repair System Products Liability Litigation–   The court ordered Mandatory Settlement Conferences for unsettled Covidien LP, Sofradim and TSL plaintiffs.     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.

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.

MDL No. 2387 | In Re Coloplast Corp. Pelvic Support Systems Products Liability Litigation – . There are no trials scheduled.

MDL No. 2511 | In Re Neomedic Pelvic Repair System Products Liability Litigation –  Settlement Program entered 11/2015.

Other TVM Verdicts and Trials

A $12.5 million jury verdict in a transvaginal mesh lawsuit was delivered 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:

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 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

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

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