Transvaginal mesh manufacturers and products
The overwhelming majority of TVM pending lawsuits have been filed against large medical device manufacturers and centralized before U.S. District Judge Joseph Goodwin in West Virginia as multidistrict litigation (MDL). The lawsuits have been consolidated to reduce duplicative discovery, avoid conflicting rulings from different judges and to serve the convenience of the parties, witnesses, and the courts. However, claims against certain smaller manufacturers such as Caldera Medical have not been included in this MDL.
American Medical Systems
AMS is a company that belongs to Endo International PLC, a global healthcare corporation with over 100 years in the industry.
Products for incontinence:
- BioArc SP Sling System
- BioArc TO Subfascial Hammock
- In-Fast Ultra Transvaginal Sling
- Influence In-fast
- In-fast Ultra
- MiniArc Precise Single-Incision Sling
- Monarc Sling System
- Monarc Subfascial Hammock
- SPARC (SUI only)
Products for POP:
- Apogee Pelvic Floor Repair System
- Apogee Systems with PC Coated IntePro Lite
- Apogee Vault Suspension System
- Elevate Anterior & Posterior Prolapse Repair System
- Elevate with InteXen LP Prolapse Repair System
- InterPro Y Sling
- Large Pore Polypropylene Mesh
- Perigee Pelvic Floor Repair System
- Perigee Systems with PC Coated IntePro Lite
- Perigree Vault Suspension System
- Spare Self-Fixating Sling System
There are thousands of open lawsuits against AMS. The company was estimated to have liability for $159.8 million in 2013. In 2014, AMS agreed to settle a number of these cases paying out $54 million and then an additional $830 million. The company is the only one to have reached a large settlement and is believed to have paid out a total of $1.6 billion in doing so. There are more than 21K product liability cases against AMS in multidistrict litigation (MDL) in federal court in West Virginia; only 1,264 are pending. In 2017, Endo made a $775 million settlement to resolve 22K mesh lawsuits.
BSC is the company responsible for producing the first transvaginal mesh devices, back in the 1990s. Its first device had to be recalled due to safety concerns. A second BSC vaginal mesh recall occurred in 2011 when the FDA recalled the Pinnacle Pelvic Repair Kits.
BSC manufactures the following TVM products:
- Advantage Fit System
- Advantage Sling System
- Lynx Suprapubic Mid-Urethral Sling System
- Obtryx Curved Single
- Obtryx Mesh Sling
- Pinnacle Pelvic Floor Repair Kit
- Pinnacle Pelvic Floor Repair Kit II
- Polyform Synthetic Mesh
- Prefyx Mid U Mesh Sling System
- Prefyx PPS System
- Solyx SIS System
- Uphold Vaginal Support System
Pending cases against BSC are filed in both state and federal courts and are claims for design and manufacturing defects, a failure to warn, breach of warranty, fraud, violations of state consumer protection laws and loss of consortium.
BSC lost two successive federal trials in 2014. A Miami, Florida jury awarded $26.7 million to four women implanted with Boston Scientific’s Pinnacle mesh devices. The women in the trial were each awarded between $6.5 million to $6.7 million. A Charleston, West Virginia jury awarded $18.5 million to four women implanted with BSC’s Obtryx mid-urethral slings. 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. In 2015, BSC made a $119 million settlement to resolve 3K mesh cases (~$40K per case).
In a quarterly report (10-Q), filed with the Securities and Exchange Commission (SEC) in May 2017, BSC admits that 37K of a pending 43K product liability cases filed against BSC will be resolved. Of those approximately 12K have met the condition of settlement and are final. The report does not specify how much has been set aside specifically for TVM settlements.
BSC recorded $10 million of litigation-related charges during the first three months of 2016. The cost of legal matters was $2 billion as of the last day of December 2017. Another $1.75 billion, including the estimated costs of damage, defense, and settlement, has been accrued earlier in 2017. There are over 25K product liability cases against BSC in multidistrict litigation (MDL) in federal court in West Virginia, and 8,603 are pending.
Covidien - Medtronic
Covidien, a leading global provider of healthcare products, was acquired by Medtronic in 2015. TVM products manufactured by Covidien:
- IVS Tunneler Intra-Vaginal Sling
- IVS Tunneler Placement Device
- Parietene Polypropylene Mesh
- Surgipro Polypropylene Surgical Mesh
In 2015, $180 million was set aside by Medtronic to settle an undisclosed number of mesh cases. The Covidien transvaginal mesh settlement was filed in West Virginia federal court amid mounting pressure from the sheer volume of lawsuits (11,3K) that have been filed against Covidien and other transvaginal mesh manufacturers. In 2017, C.R. Bard and several subsidiaries of Medtronic unit Covidien settled more than 130 product liability lawsuits brought over pelvic mesh products.
Medical device giant Becton, Dickinson & Co. acquired C.R. Bard in 2017. TVM products manufactured by C.R. Bard:
- Avaulta BioSynthetic Support System
- Avaulta Plus BioSynthetic Support System
- Avaulta Solo Support System
- Avaulta Solo Synthetic Support System
- CollaMend Implant
- Faslata Allograft
- Pelvicol Tissue
- PelviSoft Biomesh
- Pelvitex Polypropylene Mesh
- Ugytex Dual Knit Mesh
- Uretex TO
- Uretex TOO2
- Uretex TOO3
C.R. Bard was the first manufacturer to lose a TVM case. The company withdrew its TVM devices from the market in 2012, weeks before losing a $3.6 million verdict to a woman who experienced complications from the company’s device.
After losing a federal lawsuit for $2 million in 2013, Bard settled a pair of cases for undisclosed amounts. In 2014, Bard settled more than 500 lawsuits for $21 million. In 2015, C. R. Bard agreed to pay over $200 million (~$67K per case) to resolve an estimated 3K cases. Bard has agreed in principle to settle over 4K cases in 2016.
There are more than 15K product liability cases against Bard consolidated in multidistrict litigation (MDL) in federal court in West Virginia, and nearly 1K cases pending against Bard in multidistrict litigation in New Jersey.
Coloplast is one of the smaller manufacturers of transvaginal meshes. TVM products manufactured by Coloplast:
- Aris-Transobturator Sling System
- Exair Mesh
- Novasilk Synthetic Flat Mesh
- Minitape Sling
- Omnisure Sling
- Supris-Suprapubic Sling System
- T-Sling-Universal Polypropylene Sling System
Coloplast faced the second fewest number of lawsuits in the West Virginia MDL. There are currently over 2K Coloplast lawsuits filed in the So. District of W.V. Less than 500 cases were pending against the company in 2017.
Coloplast settled about 400 lawsuits for $16 million in 2014. The claimants reportedly received about $40K. The manufacturer increased its legal budget to $448 million in 2015 after courts ordered it to move forward on litigation involving 200 cases.
Cook Medical System
Cook is one of the smaller mesh manufacturers. There are 632 product liability cases filed against Cook Medical, Inc. that have been consolidated from around the country to the federal court in West Virginia. Cook has settled 19.5% of these cases.
TVM products manufactured by Cook Medical:
- Surgisis Biodesign Anterior Pelvic Floor Graft
- Surgisis Biodesign Posterior Pelvic Floor Graft
- Surgisis Biodesign Tension-Free Urethral Sling
- Surgisis Biodesign Urethral Sling
- Surgisis Biodesign Vaginal Erosion Repair Graft
Unlike most vaginal mesh products, which are synthetic, the Surgisis Biodesign bladder sling is made using the small intestines of pigs. Many women have experienced severe and debilitating complications after being implanted with Cook surgical mesh products.
Studies have indicated that TVMs based on pig intestines may show a higher risk of an inflammatory response, have a lower tensile strength than synthetic mesh, and some reports indicate that it adheres to the surrounding tissue in a way that makes it extremely difficult to remove.
Ethicon Division (Johnson & Johnson)
J&J’s Ethicon faces more vaginal mesh lawsuits than any other manufacturer. J&J’s Ethicon is one of the mesh makers who developed a polypropylene polymer to spin into a mesh:
- Gynemesh PS
- Prolene Polypropylene Mesh Patch Secur
- TVT Abbrevo
- TVT Exact
- TVT Obturator (TVT-0)
- TVT Retropubic System
- TVT Secur
Of all the mesh manufacturers, J&J’s Ethicon has been the slowest to offer settlements. Despite multiple trial losses, J&J Ethicon has refused to agree to a large settlement.
In 2013, a New Jersey jury returned an $11 million verdict against Ethicon for injuries caused by its Gynecare Prolift. In 2014, Linda Batiste won a $1.2 million state lawsuit against Johnson & Johnson.
A federal jury in West Virginia awarded $3.27 million to Jo Huskey in 2014. In 2015, Johnson & Johnson lost a $12.5 million verdict to a woman who claimed she was injured by the company’s Prolift implant. The company settled four lawsuits for an undisclosed amount in 2015.
In 2017, Peggy Engleman filed a lawsuit against Ethicon and claimed the company’s TVT-Secur mesh caused serious complications including infections, bleeding, and severe pain. A jury awarded her $20 million. Also in 2017, a New Jersey jury awarded $15 million to Elizabeth Hyrmoc.
Mentor Corporation (Johnson & Johnson)
TVM product manufactured by Mentor:
- Mentor ObTape Transobturator Sling
The ObTape vaginal sling was used in about 35K women between 2003 and 2006 to treat SUI. More than 13% of the women who received the Mentor Sling for incontinence suffered vaginal extrusions, and additional cases were reported of women who suffered chronic vaginal discharge and abscesses.
In 2015, Johnson & Johnson agreed to settle more than 100 lawsuits filed by women who claimed TVM devices manufactured and sold by the company’s Mentor unit caused them permanent injuries. The drug giant refused to disclose the amount of money it paid to 111 plaintiffs in the U.S. District Court for the Middle District of Georgia. The company had also settled a handful of cases in 2014.
In 2016, at a federal Mentor ObTape pelvic mesh trial in Georgia, a jury deliberated three hours to award plaintiff Teresa Taylor $4.4 million, which included $400K in compensatory damages and $4 million in punitive damages.
Caldera Medical makes a number of TVM products, including:
- Ascend PC
- Ascend AC
- Desara Sling System
The Caldera mesh class action lawsuit included roughly 2,7K class members. When Caldera Medical claimed they did not have sufficient insurance to cover victim compensation and legal fees, the Caldera mesh lawsuit claims were then changed to insurance claims against Federal Insurance Company.
Caldera first proposed the settlement for this class action lawsuit in 2016, but approval has been significantly delayed by 36 plaintiffs who wished to know how much the company would be worth if it were liquidated before agreeing to a deal.
Despite the efforts of these 36 plaintiffs, Judge Stephen V. Wilson approved the $12.3 million Caldera TVM settlement. Of these funds, $670K covered the cost of legal and attorneys’ fees, and the remaining $11.6 million were distributed to the class members. Class members are not able to opt-out of this settlement and pursue future claims against Caldera and Federal Insurance, and each class member received roughly $3K for suffering and damages.
Sofradim Production is a French biotechnology company affiliated with Covidien medical device maker. The following is a partial list of surgical mesh devices manufactured by Sofradim:
- Pelvetex Polypropylene Mesh Patch
- Uretex Pubovaginal Sling
- Uretex Pubovaginal Support Kit
- Uretex TO
- Uretex TO Avaulta BioSynthetic System
- Uretex TOO2
- Uretex TOO3
In 2017, Judge Joseph Goodwin settled hundreds of transvaginal mesh suits naming Sofradim Production.
Neomedic mesh products:
- Neomedic Needleless Sling
- Contasure Needleless Sling
- Remeex System/TRT Remeex System
- KIM System
- Uplift device
- Surelift device
In 2013, there were at least 22 Neomedic bladder sling lawsuits pending in eight different U.S. District Courts on behalf of at least 43 different women.
All of the injury lawsuits were brought on behalf of women who had experienced vaginal mesh or bladder sling complications after the mesh eroded through the vagina, punctured or damaged other organs, causing infections or other painful health problems.
In 2014, a panel of federal judges decided to establish a seventh Multidistrict Litigation (MDL) in the vaginal mesh litigation, centralizing all lawsuits involving pelvic repair products manufactured by Neomedic before the same judge. In 2015, Neomedic paid $2.19 million to settle an undisclosed number of mesh lawsuits.