Transvaginal mesh is surgically implanted to stabilized weakened vaginal and bladder tissues in women with pelvic organ prolapse or stress urinary incontinence. The FDA has collected thousands of serious adverse event reports regarding injuries caused by vaginal mesh. Some of these injuries have been severe and permanent and may have contributed to a number of deaths.
Thousands of lawsuits have been filed and settled regarding transvaginal mesh, however many may still remain in federal, state and local courts.
What is a transvaginal mesh lawsuit?
A medical injury lawsuit may be filed for injury or harm caused by a medical device. Wrongful death lawsuits may also be filed by family members in the event that a medical device caused the death of a loved one. Transvaginal mesh lawsuits have been filed by women and their familied due to harm resulting from implantation of transvaginal mesh.
What companies are involved in transvaginal lawsuits?
Well over 100 thousand of lawsuits have been filed by women and their families against medical device manufacturers of transvaginal mesh products. Manufacturers who have faced lawsuits for injuries cause by transvaginal mesh include:
- Ethicon and parent company Johnson & Johnson
- American Medical Systems (AMS) and parent company Endo International
- C.R. Bard, including TSL and Sofradim products
- Coloplast Corp
- Boston Scientific
- Cook Medical Inc.
- Neomedic International
- Medtronic, including Coviden and Tyco products
- Caldera Medical
Thousands of lawsuits have reached settlement, but many remain in court systems and more lawsuits may be expected.
What transvaginal lawsuits have been settled?
Tens of thousands of lawsuits have already been filed and settled for injuries caused by transvaginal mesh. Transvaginal mesh manufacturers have paid more than $1.2 billion for tens of thousands of claims but more than 60,000 cases may still be pending in federal, state and local courts.
Past transvaginal mesh lawsuit settlements have included:
- California couple awarded $5.5 million in case against Bard
- NJ woman awarded $11 million in case against Ethicon / Johnson & Johnson
- WV woman awarded $2 million in case against Bard
- 20,000 cases settled by AMS/Endo for $830 million
- TX woman awarded $34.6 million in case against Ethicon / Johnson & Johnson
- FL cases against Ethicon / Johnson & Johnson awarded to 4 women for $26.7 million and separately to another 4 woemen for $18.5 million
- 500 Bard cases settled for $21 million
- 400 Coloplast cases settled for $16 million
- 3,000 Boston Scientific cases settled for $119 million
- DE woman awarded $10 million in case against Boston Scientific
- PA woman awarded $12.5 million in case against Ethicon / Johnson & Johnson
- NJ woman awarded $15 million in case against Ethicon / Johnson & Johnson
- Three PA women awarded $2.16, $20, and $57 million in cases against Ethicon / Johnson & Johnson
Should I file a transvaginal mesh lawsuit?
Each case of medical injury is unique and must be considered separately. If you or a loved one has experienced complications or required revision surgery after implantation of transvaginal mesh for POP or SUI repair, you may be eligible for compensation.
Medical injury settlements can include compensation for:
- Medical costs
- Lost wages
- Permanent injury or disability
- Loss of consortium (spousal relationship)
- Future medical costs
- Pain and suffering
- Wrongful death
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.
Transvaginal Mesh Settlements
The first approved transvaginal mesh was recalled just three years after it was introduced because the FDA indicated that the device did “not appear to function as intended” and had a “higher than expected rate of vaginal erosion”. In 2008, a public warning was issued by the FDA regarding rare complications of transvaginal mesh. This warning was later strengthened in 2011 when the FDA stated that complications were not rare and that transvaginal mesh was not more effective than other procedures.
The FDA, in 2012, for 7 SUI and 34 POP mesh manufacturers were ordered to conduct over 100 safety studies related to the devices. Despite results and reports indicating high levels of risk, the deevices have not been recalled or discontinued and remain on the market today.
Thousands of women and their families have filed lawsuits against vaginal mesh manufactures such as
- American Medical Systems / Endo Laboratories
- Boston Scientific
- Coloplast Corp
- Cook Medical Inc.
- C.R. Bard
- Ethicon / Johnson & Johnson
Transvaginal Mesh Federal Settlements
Over 60 thousand cases have already been consolidated into six federal multidistrict litigation (MDL) cases in the U.S. District Court for the Southern District of West Virginia overseen by Chief Judge Joseph R. Goodwin. One MDL lawsuit against Ethicon, a subsidiary of Johnson & Johnson, has already been settled out of court.
The first test or “bellwether” regarding the transvaginal mesh injuries took place in June of 2013. The lawsuit was filed by a West Virginia woman against C.R. Bard. The jury awarded the plaintiff $250 thousand in actual damages (reimbursement for pain and suffering, medical costs, loss of wages) and $1.75 million in punitive damages to punish Bard for knowingly manufacturing and marketing a device which had significant risk of injury and for failure to warn of those risks.
A second bellwether trial filed by a New Jersey woman was set to begin shortly after the first, but was settled out of court before it began.
Boston Scientific was ordered to pay $26.7 million to four women in the first federal trial and $18.5 million to four women in the second federal trial in the fall of 2014. The company had previously won two state cases but still face 23,000 more lawsuits.
Johnson & Johnson, who is facing over 35,000 lawsuits for Ethicon’s vaginal mesh products, attempted to file a motion regarding their federal MDL cases, in an attempt to delay the trials or have the cases dismissed. The motion claimed that plaintiffs’ attorneys illegally solicited clients to file lawsuits but Johnson & Johnson withdrew the motion in January of 2015.
In October of 2014, C.R. Bard agreed to pay $21 million to settle 500 cases and in December, a federal judge recommended that the company consider offering settlements for thousands of the remaining federal cases as the company could otherwise be facing multiple billions in jury awards.
Transvaginal Mesh State and Local Settlements
Other lawsuits have also been filed in state and local courts, some of which have gone to trial or settled out of court. These cases have included:
2012 – A California couple was awarded a jury verdict of $5.5 million in damages against C.R. Bard
2013 – One New Jersey woman was awarded a jury verdict of $11 million in total damages against Ethicon / Johnson & Johnson
- 2013 – AMS / Endo settled an undisclosed number of lawsuits with a payment of $54 million
- 2014 AMS/Endo has also agreed to settle approximately 20 thousand cases for $830 million, however the total number may be higher if additional cases are added
- 2014 – Coloplast reported agreement to settle approximately 400 lawsuits for an estimated $16 million
- 2014 – A Texas woman was awarded a jury verdict of $73 million in damages against Boston Scientific, however the judge cut the total award to $37.5 million
Women in Texas have also asked for the state attorney general’s assistance in pursuing legal action against Johnson & Johnson, the parent company of Ethicon for damages caused by Ethicon vaginal mesh implants. The State of Texas says that it has been involved in the transvaginal mesh issue since 2012.
A Philadelphia “mass tort” filing is also accumulating with over 900 lawsuits against several manufacturers overseen by a single judge. It is the second largest mass filing in the Philadelphia system and additional plaintiffs continue to join the suit.
While some lawsuits by women claiming injuries caused by transvaginal mesh have not been successful, many more have resulted in thousands or even millions of dollars awarded to plaintiffs. Each case must be considered individually and many of the manufacturers are showing a willingness to settle some of the cases out of court.
Though thousands of lawsuits have been settled, thousands remain in federal, state and local courts and many more may be expected.
About Transvaginal Mesh
Transvaginal mesh was first introduced in the mid-1990s for the treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP). It is used for pelvic organ or bladder suspension surgery and is implanted transvaginally or through the vagina.
Transvaginal mesh was first approved based on a similarity to other mesh products already in use through a shortcut, known as the FDA 201(k) process which allows manufacturers to “skip” costly clinical trials. Many transvaginal mesh products were never used in humans until after their approval.
The FDA’s 501(k) process may be partly to blame and a statement was issued in 2008, indicating that transvaginal mesh products did not appear to be safer or more effective than other surgical treatments for POP or SUI and that the devices may increase the chance of serious adverse events. Despite this statement, transvaginal mesh continues to be manufactured and used.
Millions of women have had transvaginal mesh surgery and many of those procedures have resulted in severe, sometimes permanent injury. Thousands of lawsuits have been filed against multiple manufacturers of transvaginal mesh devices and the number may reach as high as 100 thousand cases.
Serious Side Effects of Transvaginal Mesh
Transvaginal mesh has caused injury to thousands of women, including several deaths. Women or their families who have been injured by transvaginal mesh have filed lawsuits against the manufactures. Some of these lawsuits have been settled, with many more settlements to come.
Vaginal mesh may erode and eventually perforate the vaginal wall. This may cause scarring, shrinkage and pain in the vaginal tissue. In some cases the mesh may enter the abdominal area and perforate other organs.
Serious adverse events caused by vaginal mesh often require revision surgery. In some cases, multiple surgeries may be required and some of the physical damage may not be repairable. Each surgery increases the risk of infection and bleeding and injuries may be permanent. In addition, vaginal mesh implants are linked to the deaths of several victims.