Transvaginal Mesh Lawsuits and Complications
Transvaginal mesh is a type of surgical mesh that is used to treat several different disorders. It is intended to strengthen and provide support for various urogynecologic procedures for female patients. However, there have been many concerns about its safety over the years. There have been numerous complications caused from the use of the product. In addition, the FDA has increased its regulation of the product, going so far as to restrict its marketing and usage for various types of procedures. As a result of the complications that women have experienced when they have had transvaginal mesh inserted during procedures, there are a multitude of pelvic mesh lawsuits against the manufacturers of this product.
Transvaginal Mesh was approved on the basis of weak evidence
According to a study in 2017:
- “Transvaginal mesh products for pelvic organ prolapse have been approved on the basis of weak evidence over the last 20 years.” BMJ open
- “Transvaginal mesh for pelvic organ prolapse has not even generally been subjected to adequate clinical studies at any phase of its development.” Id.
- “The available trials have been poorly designed and poorly conducted and have failed to account for variable lengths of patient follow-up, underlining the importance of properly designed clinical trials during the development of devices and careful post marketing surveillance. Devices have inherited approval status from a few products.” Id.
“So far, manufacturers have paid out billions in settlements and jury verdicts. By February 2019, 32 women had gone to trial in federal or state court, according to the New York Times. Of those women, 24 received jury awards totaling $345 million, and mesh manufacturers have paid close to $8 billion in settlements.” Drug watch While some of these lawsuits have settled, other lawsuits are at various points of the pre-trial process. If you believe that you or someone in your family has suffered harm from transvaginal mesh, please read the following regarding the nature of the problem and your legal remedies.
On 4/16/19 FDA terminates use of Transvaginal mesh in United States
- “On April 16, 2019, the FDA ordered all manufacturers of surgical mesh intended for transvaginal repair of anterior compartment prolapse (cystocele) to stop selling and distributing their products immediately. The FDA has determined that the manufacturers, Boston Scientific and Coloplast, have not demonstrated reasonable assurance of safety and effectiveness for these devices, which is the premarket standard that now applies to them since the agency reclassified them into class III (high risk) in 2016.” FDA
- “Since the FDA has not received sufficient evidence to assure that the probable benefits of these devices outweigh their probable risks, the agency has concluded that these products do not have reasonable assurance of safety and effectiveness. The companies will have 10 days to submit their plans to withdraw these products from the market.” Id.
- “Women who have received transvaginal mesh for the surgical repair of pelvic organ prolapse should continue with their annual and other routine check-ups and follow-up care. There is no need to take additional action if you are satisfied with your surgery and are not having any complications or symptoms. Id.
- “You should notify your health care provider if you have complications or symptoms, including persistent vaginal bleeding or discharge, pelvic or groin pain, or pain with sex. You should also let your health care provider know if you have surgical mesh, especially if you plan to have another surgery or other medical procedures. If you were planning to have mesh placed transvaginally for the repair of pelvic organ prolapse, you should discuss other treatment options with your doctor.” Id.
- “If you have had pelvic organ prolapse surgery but do not know whether your surgeon used mesh, ask your surgeon at your next scheduled visit.” Id.
Transvaginal mesh update
Update 9-27-2020- “JACKSON, Miss.— A company that failed to adequately inform women of dangerous side effects related to permanent pelvic mesh devices will be required to pay $60 million, according to a settlement announced late last week by state attorneys general across the U.S. The money from C.R. Bard Inc. and its parent company Becton, Dickinson and Company, will be spread out among 48 states and the District of Columbia. C.R. Bard failed to disclose serious and life-altering risks of permanently implanted surgical mesh devices, leaving thousands of women to suffer,” Mississippi Attorney General Lynn Fitch said in a statement.” Lewiston Tribune
- “A company that failed to adequately inform women of dangerous side effects related to permanent pelvic mesh devices will be required to pay $60 million, according to a settlement announced this week by state attorneys general across the U.S. The money from C.R. Bard Inc. and its parent company Becton, Dickinson and Company will be spread out among 48 states and the District of Columbia. For example, New York will receive $2.1 million, while Arizona will receive $1.15 million. Mississippi is set to receive around $840,000.” cbs
- “MONTPELIER — Attorney General T.J. Donovan today announced that C.R. Bard, Inc., and its parent company Becton, Dickinson and Company, will pay the State of Vermont $600,000 for mispresenting the safety and effectiveness of its transvaginal surgical mesh devices” VT Digger
3/4/2020- “Boston Scientific (NYSE:BSX) has agreed to settle a transvaginal mesh class action lawsuit brought by women in Canada for $21.5 million, according to a report by the Canadian Press. The proposed settlement involves about 325 women whose share of the money would depend on the severity of their medical issues, the news service reported. Final approval of the settlement is expected in June.” Mass Device
1/31/2020- “Johnson and Johnson said it will appeal a ruling in the State of California’s transvaginal mesh case that would have it pay $344 million over deceptive marketing practices for its pelvic mesh products. The California Department of Justice sued J&J and its Ethicon unit in May of 2016 alleging the company neglected to inform both patients and doctors of possible severe complications from the products and misrepresented the frequency and severity of risks the products posed. The trial began on July 15, 2019.” Medical device and diagnostic industry
Lawsuits allege that transvaginal mesh companies:
- Purposefully, mislead the U.S. Food and Drug Administration, physician, nurses, hospitals, surgeons, victims and the general public concerning the safety of the mesh
- Did not adequately test the medical device
- Did not properly research the viability, effectiveness and safety of the mesh
- Had not proper methodology for the removal of the mesh
- Did not properly warn victims of probably side effects .
The Purposes of Transvaginal Mesh
There are several different medical issues that women suffer from that necessitated the use of transvaginal mesh. The first is pelvic organ prolapse. This is when the pelvis may not stay in place due to weakened muscles and the bladder drops. This places pressure on the vagina. In this instance, the transvaginal mesh is used to stabilize and support the pelvic organ. The second is stress urinary incontinence. This is when a mild activity can cause urine to leak from the vagina. This can be something such as sneezing or coughing. This is due to the weakening of the muscles that support the bladder, such as the pelvis. The transvaginal mesh is used to strengthen the surrounding tissue which has the effect of preventing the incontinence.
How Transvaginal Mesh is Made
Transvaginal mesh can be made out of any one of a number of different materials. The most common composition of the mesh is made from plastic. It can also made with a number of other different components including animal tissue. Synthetic transvaginal mesh products are intended to be a permanent implant into the body, while mesh made out of animal products is absorbed into the body. While the name implies that it is placed in the vagina, it is actually placed through the vagina into the abdomen. The benefit of this is that the procedure spares the patient from requiring an incision to the abdomen.
There are several different companies that make or have made transvaginal mesh. Johnson & Johnson, American Medical Systems, Boston Scientific and C.R. Bard are the major sellers of the product. All told, there are over 30 companies that manufacture transvaginal mesh.
Some Key Dates and Statistics
Transvaginal mesh was initially approved for usage by the FDA under its 510(k) process, which allows for approval of a product with significant testing. The FDA approved surgical mesh for transvaginal use in 2002. The lack of a need for testing was due to its classification as a moderate-risk product. This means that the product was not tested on humans before it was approved. At its height, approximately 300,000 women per year were receiving transvaginal mesh implants during surgeries. The FDA believes that over two million women have received the implant over the lifetime of the product. In light of the complications that have been reported in connection with transvaginal mesh, this is a significant number.
Side Effects From Transvaginal Mesh
Women have reported suffering numerous side effects from transvaginal mesh implants. The most common side effects from this implant are infection and pain. In addition, women have reported experiencing urinary problems and vaginal scarring. Notwithstanding transvaginal mesh’s marketing to aid with surgery to relieve incontinence, the product has actually been reported to cause incontinence. In addition, many women have experienced the erosion of the transvaginal mesh. This is where the position of the mesh shifts such that edges of the mesh are protruding from the vagina. Many women have had to have an additional surgery to have the transvaginal mesh removed. This surgery also involves repairing the tissue that has been damaged by the mesh.
Once reports of complications began to increase, the FDA changed its classification of transvaginal mesh. In addition to classifying the mesh as a high-risk product, the FDA has also issued various safety notices relating to the transvaginal mesh. The FDA now recommends that patients ask their doctors why they are using transvaginal mesh and whether there are any other alternatives to its usage. Nevertheless, the product is still being used in the marketplace and pelvic implants are still a large potential market both in the United States and the rest of the world.
- Mesh Erosion
- Mesh Infection
- Severe Pain
- Urinary problems
- incontinence that is recurring
Transvaginal Mesh Litigation
There have been numerous transvaginal mesh lawsuits that have arisen from the use of this product. The lawsuits have typically alleged that the mesh has been designed defectively and that they are inherently dangerous for their intended purpose. The complaints have alleged that the manufacturers placed a defective product into the marketplace. The manufacturers are alleged to have possessed information about the product defects and the dangers associated with their use. Instead of warning the public about these dangers, the manufacturers did not reveal this adverse data and continued to market and sell the product as if it were entirely safe.
Manufacturers were negligent in designing and selling
In addition, plaintiffs have alleged that manufacturers were negligent in designing and selling a product that caused injury to women. The plaintiffs claim that the manufacturers owed a duty to these women, and breached it by selling a defective product. Finally, the manufacturers have been accused of fraud through their alleged representations that the products were safe and that they were tested.
Punitive damages assessed against C.R. Bard
Many of these lawsuits have been settled by the manufacturers. Some of the cases that have gone to trial have resulted in large jury awards of damages against the manufacturers. Since transvaginal mesh was not a product that required FDA testing, manufacturers can face state law product liability claims. For example, in 2018, a jury in New Jersey awarded a plaintiff and her husband $68 million in damages for injuries that she sustained due to transvaginal mesh. Nearly half of this award was punitive damages assessed against C.R. Bard for their negligence and marketing of the product. There are many other lawsuits in this case that are in various stages of the trial process.
Contact a lawyer as soon as possible
It is important to note that, not only can you bring legal action against the manufacturer of transvaginal mesh, but you can also file a complaint against the doctor who carried out the procedure. If you believe that you have been injured by transvaginal mesh or hernia mesh, it is essential that you contact a lawyer as soon as possible, especially in light of the statute of limitations for product liability cases. Your lawyer can advise you of the latest legal developments in these cases as well as the merits of your potential claim for compensation.
“These women had problems such as sitting, walking, having sex and participating in other activities, according to lawsuits. The complications were so bad that many women had to suffer through multiple revision surgeries to remove the implants.” drugwatch Over 109,000 women have filed Transvaginal lawsuits in MDLs alleging that surgical pelvic mesh causes side effects such as severe pain, stress urinary incontinence, perforated organs, pelvic organ prolapse, autoimmune complications as well as bleeding. There was a massive transvaginal mesh settlement in which manufacturers agreed to pay $830 million to 20,000 mesh victims. As of October 24, 2020 there are still over two thousand pending lawsuits against various mesh manufacturers.
Won seven figure multimillion-dollar verdicts
Since 2011, victims have prevailed in at least 20 verdicts against transvaginal mesh manufacturers. These verdicts amount to over $299 million. Mesh manufacturers have settled thousands of these lawsuits. Certain victims have won seven figure multimillion-dollar verdicts against corporate wrongdoers. In one mesh lawsuit in 2018, a jury issued a verdict in the amount of $68 million to transvaginal mesh victim. In 2019, a generous jury awarded Patricia Mesigian $80 million.
Pelvic Mesh Lawsuits pending against Boston Scientific in an MDL
As of 10/15/2020 there are currently 29 lawsuits in the MDL in Federal Court in West Virginia against Boston Scientific Corp. These 29 lawsuits are currently pending before the honorable U.S. District Judge, Joseph R. Goodwin. The MDL is: MDL -2326 called “IN RE: Boston Scientific Corp. Pelvic Repair System Products Liability Litigation.” At one time there were 26,644 lawsuits pending against Boston Scientific in the MDL. These lawsuits have been whittled down as a result of a massive transvaginal lawsuit settlement.
Transvaginal lawsuits pending against Ethicon, Inc.
As of 10/15/2020 there are currently 284 lawsuits in the MDL in Federal Court in West Virginia against Ethicon, Inc. Ethicon is a subsidiary of Johnson and Johnson. These 284 lawsuits are currently pending before the honorable U.S. District Judge, Joseph R. Goodwin. The MDL is: MDL -2327 IN RE: Ethicon, Inc., Pelvic Repair System Products Liability Litigation. At one time there were 40,870 lawsuits pending against Ethicon, Inc. in the MDL. These lawsuits have been whittled down as a result of a massive transvaginal lawsuit settlement. In November 2019 there were 1,202 lawsuits pending.
Lawsuits against Bard
On 04/13/2020 the honorable Justice Joseph R. Goodwin (U.S. District Judge) closed MDL -2187 known as “IN RE: C.R. Bard, Inc., Pelvic Repair System Products Liability Litigation.” In November of 2019 there were just 16 remaining transvaginal mesh lawsuits remaining in this MDL. At the apex of this litigation there were 15,868 pelvic mesh lawsuits pending.
Bard made over 12 types of Transvaginal mesh including:
- Avaulta Plus™ BioSynthetic Support System for POP ( Pelvic organ prolapse)
- Avaulta Solo™ Synthetic Support System for POP
- Faslata® Allograft – human graft tissue
- Pelvicol® Tissue for SUI (stress urinary incontinence)
- PelviSoft® Biomesh for SUI
- Pelvitex™ Polypropylene Mesh for SUI
American Medical lawsuits
On 4/15/19 there were 352 pelvic mesh lawsuits pending in Federal Court for the Southern District of West Virginia before Joseph R. Goodwin (U.S. District Judge) in MDL -2325 (IN RE: American Medical Systems, Inc., Pelvic Repair System Products Liability Litigation. In November, 2019 there were 80 remaining lawsuits in this mdl. At the height of this litigation there were 21,362 lawsuits pending against American Medical.
5/1/2014- “The Food and Drug Administration (FDA or the Agency) is proposing to reclassify surgical mesh for transvaginal pelvic organ prolapse (POP) repair from class II to class III. FDA is proposing this reclassification based on the tentative determination that general controls and special controls together are not sufficient to provide reasonable assurance of safety and effectiveness for this device. In addition, FDA is proposing to reclassify urogynecologic surgical mesh instrumentation from class I to class II. The Agency is also proposing to establish special controls for surgical instrumentation for use with urogynecologic surgical mesh. FDA is proposing this action, based on the tentative determination that general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of these devices, and there is sufficient information to establish special controls to provide such assurance. The Agency is reclassifying both the surgical mesh for transvaginal repair and the urogynecologic surgical mesh instrumentation on its own initiative based on new information.” Federal Register
Joseph R. Goodwin (U.S. District Judge) MDL -2387 IN RE: Coloplast Corp. Pelvic Support Systems Products Liability Litigation 156 2,752
Cook Medical, Inc. MDL
This mdl before Joseph R. Goodwin (U.S. District Judge, Southern District of West Virginia) had 645 lawsuits pending at its zenith. In June of 2o19 the MDL only had one pending action and was subsequently closed. The MDL was known as: MDL -2440 IN RE: Cook Medical, Inc., Pelvic Repair System Products Liability Litigation.
Coloplast Corp. MDL
This MDL was pending before Joseph R. Goodwin (U.S. District Judge). The MDL is now closed. The lawsuit was known as, “MDL -2387 IN RE: Coloplast Corp. Pelvic Support Systems Products Liability Litigation.” As of 6/19/19 there were only 114 lawsuits pending in this MDL. At the zenith of this MDL there were as many as 2815 Total Actions (Historical).
Transvaginal mesh settlements 2014-2017
- MAY- AMS resolves 20,000 lawsuits
- JANUARY- Coloplast resolves 400 claims
- OCTOBER- Bard reaches settlement with victims in 500 claims
- JANUARY- Ethicon reaches settlement with four claimants
- APRIL- Boston Scientific resolves 3,000 lawsuits.
- AUGUST- Bard settles 3,000 transvaginal lawsuits.
- DECEMBER Neomedic victims reach settlement agreement- 112 lawsuits.
- January- Victims reach agreement with Ethicon- 3,000 lawsuits.
- AUGUST- Remaining 22,000AMS lawsuits resolved.
- DECEMBER- Boston Scientific announces resolution of approximately 350 lawsuits.
Pelvic mesh verdicts
- Dunfee vs. Ethicon: “It was another Friday verdict in the Philadelphia Court of Common Pleas. This time the jury decided Linda Dunfee should receive $500,000 in her pelvic mesh case against Johnson & Johnson, and its Ethicon device division. This was the 9th time jurors decided the Ethicon mesh was defective in design and manufacture and that the defective design was the cause of Mrs. Dunfee’s injuries.” Mesh Medical Device News Desk
- Mesigian v. Ethicon: “A jury has awarded $80 million to a couple, Patricia and George Mesigian, in a lawsuit against Ethicon, a subsidiary of Johnson & Johnson, over its Prolift pelvic mesh product. The verdict included $50 million in punitive damages and $30 million in compensatory damages.” Legal Scoops
- McFarland v. Ethicon: “A subsidiary of Johnson & Johnson must pay $120 million to a Pennsylvania woman who was severely injured by vaginal mesh implanted to treat urinary incontinence. A Philadelphia jury found that the J&J subsidiary, Ethicon, was negligent in the design of its TVT-O device, a strip of plastic mesh that had eroded into the Altoona woman’s vagina.” Inquirer
- McGinnis v. C.R. Bard: “A New Jersey jury awarded Mary and Thomas McGinnis a total of $68 million in April 2018 in her lawsuit against C.R. Bard. Mary McGinnis had been injured after being implanted with an Avaulta Solo and an Align Transobturator. The award to the Raleigh, N.C., couple was comprised of $33 in compensatory damages and $35 million in punitive damages. “I’ve very grateful,” Mary McGinnis said as she left the courtroom with her husband, according to northjersey.com. “This case was fought for all the victims of mesh, whom I hold in my heart.” Drug watch
- “Blankenship, Campbell, Tyree and Wilson v. Boston Scientific: “Jeanie Blankenship, Carol Sue Campbell, Jacquelyn Tyree and Chris Rene Wilson had each been implanted with the Boston Scientific Obtryx product. In 2014, a New Jersey jury held Boston Scientific responsible for the women’s medical bills and suffering. The four women shared $14.5 million for their injuries and another $4 million in punitive damages. That total $18.5 million award was upheld by an appellate court in February 2018.” Id.
- DuBois-Jean, Dotres, Nunez and Betancourt v. Boston Scientific- “The jury awarded a total of $27 million in November 2014, but did not award Plaintiffs punitive damages. Plaintiff Mania Nunez received $6.53 million, Juana Betancourt and Amal Eghnayem each received $6.72 million and Margarita Dotres received $6.76 million.” Beasley Allen
- Hammons v. Ethicon- Patricia Hammons was awarded $12.5 million from a jury. Hammons filed a lawsuit against J&J for injuries for complications caused by a Prolift implant Hammons had numerous revision surgeries. The jury gave out $5.5 million as a result of her side effects caused by the surgical mesh. The Jury awarded the victim $7 million as punitive damages to punish the manufacturer. This award was upheld on appeal.
- Engleman v. Ethicon- The transvaginal mesh victim prevailed against Ethicon for $20 million. The jury determined that Ethicon’s TVT-Secur medical device lead to severe complications and Ehicon failed to properly warn the victim. The transvaginal mesh caused severe pain, infections and bleeding. The victim endured numerous surgeries according to the transvaginal mesh lawsuit.
- Hyrmoc v. Ethicon- the victim prevailed in her lawsuit against ethicon. The Ne Jesey jury awarded the mesh victim $4 million for pain and suffering. The Jury awarded Ms. Hymoc $10 million which constituted punitive damages The jury gave $1 million for loss of consortium. The victim was implanted with Ethicon’s Prolift and transvaginal tape for incontinence. She was subjected to numerous corrective surgeries. The victim suffered side effects, complications and sever pain.
- Ebaugh v. Ethicon– A generous jury of he victims’ peers hit thicon with a $57.1 million in favor of the mesh victim. The victim suffered debilitating and excruciating pain while both sitting and standing.
- Beltz v. Ethicon-Sharon The victim whacked Ethicon in May 2017. Ms. Beltz alleged that Prolift mesh lead to side effects. The the Supreme Court of Philadelphia sustained the verdict.
- Carlino v. Ethicon- The victim won her jury trial against Ethicon with a $13.7 million verdict in her favor.
- Gross v. Ethicon- Linda Gross was implanted with Prolift manufactured by Ethicon. She had trouble sitting without debilitating pain. In the winter of 2013, a New Jersey jury slammed Ethicon with $3.35 million award for her damages as well as an award of $7.76 million for punitive damages.
There have been various transvaginal mesh class actions which are beyond the scope of this article.