Miami Transvaginal Mesh Lawyer: Sean M. Cleary
If you have suffered abdominal and vaginal pain and bleeding after being implanted with transvaginal mesh, call us and we will evaluate your case.
If you have suffered abdominal and vaginal pain and bleeding after being implanted with transvaginal mesh, call us and we will evaluate your case.
If you have had a transvaginal mesh implant and are having serious medical issues, we will research, investigate, and bring your claim against the manufacturer.
Surgical mesh has been used for transvaginal repairs of pelvic organ prolapse (POP) and to treat stress urinary incontinence (SUI) since the 1990s. Around 20% of women are affected by SUI after childbirth. According to a statement issued by the Food and Drug Administration (FDA), there were over 126K adverse events reported relating to transvaginal mesh (TVM) kit failures and 49 recalls for the various manufacturers involved. An article in the journal Obstetrics & Gynecology noted that as many as 15% of all women who have received the mesh implant would experience erosion. Traumatic complications mean one in 15 women fitted with the most common type of TVM will require surgery to extract it, figures suggest.
To date, over 100K transvaginal mesh claims have been filed, making it one of the most significant mass torts in history. The TVM has received approval from FDA for transvaginal repairs of POP and SUI in 2002. Manufacturers got approval for TVMs by following a system which allowed release without extensive testing, as long as there were similar products on the market. This lack of rigorous testing meant that problems that emerged later during use were not spotted until it was too late for the victims. The TVM has not been recalled, but the FDA reclassified TVMs used to repair POP as Class III high-risk devices, the highest-risk category the FDA has for medical devices.
Many women have suffered serious complications because of faulty TVM implants. In some cases, even surgery cannot remove the mesh or repair the internal organ damage. Serious complications associated with TVM implants include:
The most severe problems result from mesh erosion that occurs when the rough edges of the device cut through nearby organs. The FDA issued a public warning regarding these severe complications women are facing. TVM materials are not biologically compatible with human tissue, prompting an immune response and contributing to severe adverse reactions to the mesh. The TVM implant has been the subject of recall since 1999. Some manufacturers have voluntarily issued a mesh recall or have discontinued their TVM products.
Seven deaths were reported to FDA between 2008 and 2010. However, due to the nature of the reporting system, death may be reported as malfunctions and injuries. According to Medscape, an FDA review of records for all urogynecological mesh products spanning the years 2005 to 2010, there were over 3K reports of malfunctions, injuries, and deaths.
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.
AMS is a company that belongs to Endo International PLC, a global healthcare corporation with over 100 years in the industry.
Products for incontinence:
Products for POP:
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:
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, a leading global provider of healthcare products, was acquired by Medtronic in 2015. TVM products manufactured by Covidien:
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:
C.R. Bard was the first to lose a TVM case. They withdrew from the market the TVM devices in 2012, weeks before losing a $3.6 million verdict.
After losing a federal lawsuit in 2013 for $2 million, Bard settled some cases for undisclosed amounts. In 2014, Bard settled over 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:
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 allegedly received about $40K. The manufacturer increased its legal budget in 2015 to $448 million after courts ordered it to move forward on litigation involving 200 cases.
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:
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.
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:
J&J’s Ethicon has been the slowest mesh manufacturer to offer settlements. Despite several trial losses, J&J Ethicon has refused to agree to a large settlement.
In 2013, for injuries caused by its Gynecare Prolift, a New Jersey jury returned an $11 million verdict against Ethicon. Linda Batiste won in 2014, 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 injured by the Prolift implant. In 2015, the company settled four lawsuits for an undisclosed amount.
In 2017, Peggy Engleman sued Ethicon and claimed that the TVT-Secur mesh caused infection, bleeding, and severe pain. She was awarded her $20 million. Also in 2017, a New Jersey jury awarded $15 million to Elizabeth Hyrmoc.
TVM product manufactured by Mentor:
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:
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. Some of the surgical mesh devices made by Sofradim:
In 2017, Judge Joseph Goodwin settled hundreds of transvaginal mesh suits naming Sofradim Production.
Neomedic mesh products:
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.
Many of the serious injuries to women associated with TVM products are not unique to any particular product, but rather are common throughout the industry. If you have suffered side effects because of a faulty TVM implant, you are eligible to claim compensation for pain, suffering, and losses (earning capacity, medical bills, past and future medical expenses). The amount of compensation you can claim will depend on your injuries, and whether they are an ongoing issue.
Case details for our clients who were injured by the TVM implant:
We are actively pursuing cases regarding transvaginal mesh devices implanted through surgery. We firmly believe that manufacturers of medical devices have a responsibility to consumers who use their products to make them safe and, at the very least, to disclose all the risks and alternatives. When this doesn’t happen, and injuries are involved, the victims often deserve to be compensated. Sean Cleary is experienced in cases such as these and can help ladies across Florida understand their rights concerning injuries caused by transvaginal meshes.
While alternatives to lawsuits are preferred, when large corporations fail to step up and do the right thing, as so often is the case, legal action may be the only way to get results. Women who have been injured by transvaginal mesh products may be required to undergo multiple, painful surgeries to correct the issue. In some cases, their lives and long-term health may be at risk. If this is the case, a transvaginal mesh lawsuit may be the best, if not the only, course of action.
If you or a loved one have experienced complications from a transvaginal mesh product, contact our product liability lawyer, Sean M. Cleary to discuss your options and eligibility for a claim. Call 305.416.9805 for a free no-obligation case evaluation. Our office staff will help evaluate your case and ensure that you receive the compensation deserved for the health risks you have faced.
A class-action lawsuit, where the plaintiffs can avoid the high cost of litigation by pooling their resources, can be an option for women who have been injured by vaginal meshes – yet compensation may be more limited. Consult an attorney to see if this is the best solution in your case.
View full answerIf you are considering filing a vaginal mesh lawsuit, you can ground it on counts of fraud, product liability or negligence, and you can file an individual lawsuit or join a class action lawsuit. For options and the best course of action in your case, contact a specialized attorney.
View full answerFor questions and free legal advice to help individuals please call us
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