Transvaginal Mesh Lawsuit – Complications, Recall, Settlements
A successful transvaginal mesh lawsuit can net millions in damages, but unfortunately cannot undo the pain and suffering of those involved. Across the United States, women have filed claims against mesh manufactures for a range of transvaginal mesh complications: organ perforation, vaginal scarring, chronic infection, among other severe and life-changing side effects.
Background on transvaginal mesh complications
Transvaginal mesh implants were introduced a decade ago and quickly rose to popularity as a treatment for stress urinary incontinence (SUI) and pelvic organ prolapse (POP). In 2010, more than 300,000 women underwent mesh surgery. But just months later, in July 2011, the FDA issued a public safety warning for all brands of transvaginal mesh. The warning was issued after the FDA had received thousands of consumer complaints, and had reviewed research and studies into the effectiveness and safety of vaginal mesh implants. Among other results, the FDA revealed that an incredible 10 percent of all women will experience severe complications from their surgery.
Complications from transvaginal mesh implants may include:
- Pelvic organ prolapse (POP) recurrence due to vaginal mesh failure
- Return of stress urinary incontinence (SUI)
- Perforation of the bowel, bladder or blood vessels
- Severe pain in the vagina, legs, pelvis or abdomen
- Chronic infection around the mesh
- Body rejects the mesh, indicating additional surgeries
- Recurring urinary tract infections
- Vaginal scarring and chronic bleeding
- Urinary incontinence even in patients who were not incontinent before surgery
- Mesh erosion or extrusion into the vagina
- Mesh erosion or extrusion into other internal organs, including the bladder, bowel, rectum (known as rectocele) or urethra
Vaginal mesh lawsuit allegations & FDA warning
When transvaginal mesh first became popular, women were assured that the procedure was low-risk. Many later discovered that the potential for vaginal mesh complications was actually a 1 in 10 risk – and that those complications could be life changing. In fact, the FDA labels these risks as “not uncommon,” and warns, ” it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP.” Furthermore, vaginal mesh “may expose patients to greater risk.”
As a result, transvaginal mesh lawsuit allegations range from pain and suffering to the lasting effects of these injuries. For example, chronic vaginal infection and other side effects can result in painful intercourse, which in turn can create problems with intimacy. Women and their partners involved in litigation may seek damages for emotional trauma, medical expenses, lifestyle adjustments and loss of spousal consortium, among other complaints.
Common defendants in mesh lawsuits
Many different manufactures create and distribute vaginal mesh products. Common transvaginal mesh lawsuit defendants include:
- American Medical Systems (Endo Health): Manufactures mesh products known as Elevate, Apogee, and Perigee
- Boston Scientific: Manufactures Pinnacle and Uphold
- C.R. Bard, Inc.: Manufactures Avaulta, Pelvisoft BioMesh, Pelvilace, Pelvitex, Pelivicol Acellular and Collagen Matrix mesh implants
- Caldera Medical: Manufactures Ascend Anterior and Ascend Posterior products
- Coloplast Corp.: Manufactures Novasilk, Restorelle, Exair, Aris, Supris, Omnisure & Minitape Sling
- Cook Medical: Manufactures the Surgisis Biodesign Sling & Floor Graft, Stratasis Urethral Sling
- Johnson & Johnson/Ethicon: Manufactures Gynecare Prolift, Gynecare Prosima, Gynecare TVT, and ObTape
Status of multidistrict litigation (MDL)
Multidistrict litigation, or MDL, consolidates vaginal mesh lawsuit complaints from around the United States. Notably, with MDL litigation plaintiffs may pool resources but each retains his or her individual case and rights to settlement or jury decision. Currently, cases against five separate defendants have been consolidated under one judge in the U.S. District Court for the Southern District of West Virginia. These include:
- American Medical Systems, Inc. (Multidistrict Litigation No. 2325)
- Boston Scientific Corp. (Multidistrict Litigation No. 2326)
- Coloplast (Multidistrict Litigation No. 2387)
- C.R. Bard, Inc. (Multidistrict Litigation No. 2187)
- Cook Medical, Inc. (Multidistrict Litigation No. 2440)
- Ethicon, Inc. (Multidistrict Litigation No. 2327)
Additionally, litigation against the Johnson & Johnson’s Mentor ObTape has been centralized in multidistrict litigation in the U.S. District Court for the Middle District of Georgia. Manufacturer-defendant Johnson & Johnson has already settled with some MDL plaintiffs.
Class action vaginal mesh lawsuit
The difference between the MDL and a class action lawsuit is mainly that in a class action, multiple claims are tried together as a whole. Women involved in a class action lawsuit will file just one lawsuit together in order to giver their attorneys the resources and leverage to negotiate a common settlement to be split across the group. Class action suits require a special legal process to be formed. Several class action lawsuits have launched around the globe, for example in Australia and Canada, but most consolidated litigation in the United States is restricted to MDL complaints.
Notable transvaginal mesh lawsuit settlements & jury verdicts
Though litigation is largely still in various stages of discovery, serious damages loom on the defendants’ horizons. The most significant jury verdicts to date include a $5.5 million award, issued to an individual plaintiff and her husband in the Kern County Superior Court of California. The plaintiff suffered through at least eight surgeries and extreme pain dealing with transvaginal mesh complications. She was awarded $5 million, while her husband was granted $500,000 for loss of spousal consortium.
More recently, in the case of Gross v. Gynecare, a New Jersey jury rendered a $3.35 million verdict to Linda Gross for injuries she sustained from Ethicon’s Prolift mesh. The court awarded an additional $7.6 million in punitive damages, making it the most costly verdict yet against a vaginal mesh manufacturer.
Thousands of vaginal mesh lawsuit plaintiffs await their day in court, either individually both on the state and federal level. To learn more about this litigation or to receive a free case evaluation of your potential claim, contact a vaginal mesh lawyer today.
- J&J Halts Sales of Vaginal Mesh Implants, Retrieved from: http://www.reuters.com/article/2012/06/05/jj-mesh-idUSL1E8H5FUK20120605
- FDA Warns of Vaginal Mesh Complications, Retrieved from: http://www.fda.gov/medicaldevices/safety/alerts