In the U.S. and around the world, thousands of women have been harmed by transvaginal mesh implants, with many requiring multiple surgeries to have the mesh removed. Vaginal mesh was widely used to treat pelvic organ prolapse and other pelvic floor disorders, despite a lack of long term data concerning its safety, and around 10% of patients have experienced complications, often severe. The debilitating pain and potentially permanent side effects, in addition to financial concerns and emotional difficulties, have left many patients seeking justice.
Transvaginal Mesh Lawsuit Allegations
More than 100,000 transvaginal mesh lawsuits alleged the implants caused complications including pain, bleeding, infection, organ perforation and autoimmune problems. So far, one of the largest mesh settlements was about $830 million for 20,000 cases. As an update, more than 47,000 lawsuits are still pending. Some women who filed lawsuits have won multi-million-dollar verdicts against mesh manufacturers. One of the jury verdicts sided with Christine Scott and her husband. They won a $5.5 million jury award in 2013. Since 2012, women who have sued companies over transvaginal mesh have won at least 20 verdicts in state and federal courts totaling around $300 million. By March 2017, multiple companies had settled thousands of claims for millions.
As of September 2018, seven mesh makers faced 47,724 lawsuits in multidistrict litigation (MDL) in West Virginia. Johnson & Johnson’s Ethicon unit faces 22,527 lawsuits — the most of any manufacturer — followed by Boston Scientific at 15,277, Bard at 6,395 and American Medical at 3,102. FDA involvement in these cases have been instrumental to the progression of public safety warning and motions to remove the meshes from the market place. The timeline of the FDAs involvement can be summarized as follows:
- October 2008: Public health notification about more than 1,000 reports during the preceding three years related to gynecological mesh
- July 2011: FDA safety communication update on serious transvaginal mesh complications, with more than 2,800 additional reports submitted between January 2008 and December 2010
- May 2014: FDA published a proposed order requiring pre-market approval for surgical mesh used in transvaginal pelvic organ prolapse repair
- January 2017: The proposed pre-market approval requirement went into effect, with updated rules published in the Federal Register
- September 2017: Another FDA safety communication related specifically to synthetic materials used to make Boston Scientific’s composite mesh
- Future: Time will tell what is to come and what other processes and rulings the FDA will be involved in and how else they will help fight for these women
Victories to Enjoy and Battles to Fight
Johnson & Johnson lost the first bellwether trial involving its transvaginal mesh implants. In February 2013, a New Jersey jury returned an $11 million verdict against Ethicon for injuries caused by its Gynecare Prolift. Linda Gross claimed that she required 18 revision surgeries after receiving the mesh implant. She said she could not sit comfortably and had to take pain medication after her device caused complications. The jury agreed that Johnson & Johnson failed to warn of the risks associated with the device and that it made fraudulent representations about the product. Gross was awarded $3.35 million in compensation and $7.76 million in punitive damages.
A staggering victory for victims of the mesh implants was Ella Ebaugh: In September 2017, a Philadelphia jury awarded $57.1 million to Ella Ebaugh, who says she suffered chronic pain and incontinence because of two Ethicon pelvic mesh implants that eroded into her urethra. Ms. Ebaugh says she required three surgeries to remove the mesh. Ethicon vowed to appeal.
One of the largest single payouts in the Transvaginal Mesh Lawsuits was awarded to Peggy Engleman: In August 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. Engleman originally received the mesh in 2007 to treat urinary incontinence. Even after multiple surgeries to remove the product, mesh fragments remain in her body.
“In March 2018, a jury in Indiana awarded $35 million to Barbara and Anton Kaiser. They’d sued Ethicon (a subsidiary of Johnson & Johnson) after Barbara Kaiser’s Prolift mesh allegedly caused her pelvic pain. They awarded her $10 million in damages and hit Ethicon with $25 million in punitive damages.
Johnson & Johnson agreed to pay $120 million to settle 2,000-3,000 mesh lawsuits in January 2016. The settlement marked the first serious attempt by Johnson & Johnson to settle a significant number of mesh lawsuits. A regulatory filing at the time showed that J&J still was fighting more than 42,000 mesh cases.
Contact Us Today
If you or a loved one have suffered because of a failed transvaginal mesh implant, contact us today. Our legal team will sit down with you and review your case with you and talk with you about what options are available to you. We can help you with every step of the process and will fight with you and for you to help you get the compensation you deserve for your pain & suffering and loss of quality of life.