Transvaginal Mesh FINALLY Pulled from Market
On April 15, The FDA ordered the only two remaining manufacturers of mesh used for transvaginal repair of pelvic organ prolapse to stop selling the products in the U.S. Unfortunately, this is too little too late for thousands of women injured by the mesh. Litigation over pelvic mesh is one of the largest mass tort cases in history. More than 100,000 women have filed suit due to injuries including bleeding, pain, inflammation, pain during sex, and perforation of organs. Many women have had multiple surgeries to attempt to remove the mesh but continue to suffer ongoing symptoms and complications.
For years women and legal advocates have tried to persuade the FDA to do something about pelvic mesh. In 2016 The FDA reclassified the mesh as high risk which would require the manufacturers to submit applications to gain premarket approval to continue marketing them in the U.S. All but two mesh manufacturers declined to do this and withdrew their products from the market in 2018. Boston Scientific and Coloplast filed applications for their devices but the FDA found that they had not demonstrated a reasonable assurance of safety and effectiveness for the devices (source: showardlaw.com).
SIDE-EFFECTS AND ADVERSE EVENTS LINKED TO TRANSVAGINAL MESH AND VAGINAL SLING PRODUCTS
Transvaginal mesh and vaginal sling products have been linked to thousands of reported serious, life-threatening side effects or adverse events from 7 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
The injuries that women are alleged to have suffered from this mesh implant are severe and debilitating and could have been avoided had people had the proper information.
The edges of the mesh/sling can cut through the skin after implantation, causing infection and cutting into nearby structures sometimes puncturing the bladder, bowel, and uterus.
Complications from these infections can include incontinence, extreme pain during intercourse, UTI, back pain, inability to walk, etc. Some of these infections can spread through the whole body and lead to death.
(Source: Torhoermanlaw.com/defective_product_lawsuit/vaginal-mesh/)
Releases & Articles
April 1, 2016: FDA Release on Boston Scientific Urogynecologic Mesh:
Boston Scientific Surgical Mesh May Contain Counterfeit Raw Material
January 15, 2016: Transvaginal Mesh is the Stuff of Nightmares
"...surgical Mesh to be reclassified as class III or high risk medical device...", may be off the market by 2019 Read More in the Daily Beast
April 24, 2015: Use and risks of surgical mesh for pelvic organ prolapse surgery in women in New York state: population based cohort study
Study Shows that despite multiple FDA warning use of Transvaginal Mesh increased by 44.7%
July 13, 2011: FDA Safety Communication:
UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse
SOURCES:
https://www.molllawgroup.com/blog/delaware-court-reduces-transvaginal-mesh-product-liability-claim-verdict-25-million-10...
https://www.drugwatch.com/transvaginal-mesh/verdict-settlement/
https://www.carolynstclair.com/medical-device-lawsuit/transvaginal-mesh/ https://www.medicalmalpracticehelp.com/news/large-transvaginal-mesh-verdicts/
https://www.theexpertinstitute.com/15-million-johnson-johnson-pelvic-mesh-verdict-new-jersey/ https://www.law.com/thelegalintelligencer/2019/04/12/pa-appellate-court-affirms-13-5m-pelvic-mesh-verdict/?slreturn=2019...
https://www.meshmedicaldevicenewsdesk.com/mesigian-prolift-pelvic-mesh-trial-underway-in-philadelphia/ https://www.fiercebiotech.com/medtech/philadelphia-juries-knock-j-j-two-multimillion-dollar-verdicts-vaginal-mesh-cases https://www.beasleyallen.com/news/jj-hit-with-80-million-verdict-in-latest-vaginal-mesh-trial/ https://www.inquirer.com/business/pelvic-mesh-verdict-80-million-johnson-and-johnson-media-woman-20190517.html
Latest transvaginal mesh verdicts
May 2019 - Johnson & Johnson’s Ethicon unit has been ordered by a Philadelphia jury to pay $80 million to a woman whose vaginal mesh implant eroded following a 2008 procedure, and who said it caused pain, inflammation and infections.
The Pennsylvania state court’s verdict includes $50 million in punitive damages; the jury found that Ethicon’s Prolift mesh was defective and that J&J had failed to adequately describe the device’s risks when treating pelvic organ prolapse, according to a report from the Philadelphia Inquirer.
April 2019 - $120 million – McFarland v. Ethicon/JJ (TVT-O) PA
April 2019 - The Pennsylvania Superior Court rejected a Johnson & Johnson subsidiary’s efforts to overturn a $13.5 million verdict over injuries a Philadelphia jury determined were caused by a pelvic mesh device implanted during surgery.
A unanimous three-judge Superior Court panel on Thursday affirmed the multimillion-dollar verdict in Carlino v. Ethicon, which a jury awarded in February 2016. The case was the second pelvic mesh trial in Philadelphia state court, and ended with a verdict of $3.5 million in compensatory damages and $10 million in punitive damages. (Source: law.com/thelegalintelligencer/2019/04/12/pa-appellate-court-affirms-13-5m-pelvic-mesh-verdict/?slreturn=20190503221827)
April 2019 - A single $120 million verdict was issued against Ethicon in a Philadelphia court, related to a woman who received a mesh implant to treat urinary incontinence.
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.
January 31, 2019 - In Philadelphia, $41 million was awarded to a transvaginal mesh plaintiff by a jury against Johnson & Johnson’s subsidiary, Ethicon Inc.
January 2019 - $41 million – Emmett v. Ethicon/JJ (Prolift & TVT-O) PA
June 2018 - PA State Appeals court backs $12.8M verdict against Johnson & Johnson subsidiary in medical mesh defect case
April 2018 - $68 million – McGinnis v. Bard (Solo & Align) NJ
March 2018 - In Indiana, $35 million – Kaiser v. Ethicon/JJ (Prolift)
January 2018 - In Bergen County, NJ a jury handed down a $15 million verdict against Ethicon, a company owned by Johnson and Johnson, based on defective pelvic mesh implants that caused plaintiff Elizabeth Hrymoc chronic pain. The verdict consisted of $4 million for pain and suffering, $1 million for loss of consortium, and $10 million in punitive damages.
September 2017 - In Philadelpia, $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.
Even after settlements and verdicts with more than 100,000 women, there are still more than 50,000 unresolved pelvic mesh cases pending against eight manufacturers. Many of those cases are consolidated in the U.S. District Court of the Southern District of West Virginia, with at least 30,000 more filed in State Courts all over the country.
Manufacturers include:
- Boston Scientific
- American Medical Systems
- J&J Ethicon
- C. R. Bard
- Coloplast
- Cook Medical
- Neomedic
- Caldera (insolvent)
BOSTON SCIENTIFIC:
- 2014: W.V. verdict $18.5 million
- 2014: Fla. Verdict $26.7 million to four women (Pinnacle device)
- 2014: Texas verdict $73 million
- 2015: Delaware jury award $100 million to one woman
- 2015: first mass settlement to 2,970 women $119 million
- Still about 22-23,000 cases pending against Boston Scientific
- 2016: another $200 million to settle with at least another 3,000 women
AMERICAN MEDICAL SYSTEMS/ENDO PHARMACEUTICALS:
- 2012: settled unknown number of claims for $54.4 million, court approved
- 2013: company then estimated additional exposure of $160 million.
- May 2014: company entered into another agreement with 20,000 women for $830 million
- September 2016: increased the settlement to $1.6 billion to try to settle all claims with approximately 25,000 women
C. R. BARD:
- 2012: $5.5 million California verdict
- July 2013: $2 million N.J. award to Donna Cisson
- A few days later—settled second bellweather trial
- Third bellweather—settled in September
- 2014: agreed to pay $21 million to settle with 500 women, but over 10,000 cases still then pending
- 2015: agreed to pay another $200 million to settle with another 3,000 women. Again, claims of 12,000 women still pending with over 7,000 in federal court
- 2015: another $121 million for 6,470 women for Bard’s subsidiary Medtronic Mesh
- Also 2015: Bard’s subsidiary Covidien agreed to pay $121 million for 2,300 of 11,300 claims pending
COLOPLAST:
- 2014: $16 million settlement claims with 400 women. Has another 2,323 claims still pending just in the federal court - MDL alone
- 2015: announced $727 million set aside for currently pending cases
JOHNSON & JOHNSON/ETHICON:
- Over 55,000 cases have been filed in federal and state courts
- Four major individual settlements of bellweather trials on eve of trial prior to 2014
- 2013: $11 million N.J. verdict
- 2013: $1.2 million verdict in Texas
- March 2015: $5.7 million verdict in California
- December 2015: $12.5 million verdict to Philadelphia woman
- February 2016: $4.4 million Fla. verdict bladder sling, not a POP kit
- February 2016: $13.5 million verdict in N.J.
- April 2016: $5 million settlement to one woman
- January 2016: agreed to pay $120 million to resolve 2-3,000 cases.
J&J has been the last major manufacturer to come to the settlement table on mesh cases. It has announced it has spent about $4 billion defending these cases—and again, is still defending at least 38,000 cases still pending, just in Federal courts alone.
