Johnson & Johnson and subsidiary Ethicon Inc. are facing a growing vaginal mesh multidistrict litigation (MDL), with a Pennsylvania woman’s TVT Abbrevo lawsuit being one of the most recent additions. According to her TVT Abbrevo lawsuit, the woman had suffered vaginal mesh complications soon after the device was implanted.

Plaintiff Carol F. had decided to file this TVT Abbrevo lawsuit after discovering the medical device’s link with serious vaginal mesh complications, with the manufacturers allegedly failing to disclose this vital safety information. The marketing materials reportedly emphasized the device’s benefits, and failed to sufficiently describe the device’s side effects.

Similar to other women who are recommended vaginal mesh products, Carol had opted for the TVT Abbrevo to fix either her pelvic organ prolapse (POP) or stress urinary incontinence (SUI). The device was reportedly implanted on Feb. 11, 2013, after she and her doctor reviewed the marketing materials from Johnson & Johnson.

Carol says she used the TVT Abbrevo for its intended purpose, and had followed all post surgical instructions after the implant procedure. Even with this diligence, Carol still reportedly suffered serious vaginal mesh complications and has since had to contend with her compounded medical condition. Carol opted to file her TVT Abbrevo lawsuit into the MDL after discovering many women experienced similar complications and had to undergo revision surgery to resolve them.

Overview of Vaginal Mesh Complications

Vaginal mesh has been in popular use for decades, after it was discovered hernia mesh could also be used as an effective treatment for pelvic organ prolapse. Since the mid-1990s, several manufacturers have been competing to offer mesh products specifically made to treat POP and SUI.

Vaginal mesh quickly became a popular option for women looking for discrete treatment methods but who were largely unaware of the potential problems. However, manufacturers have been repeatedly criticized for deliberately downplaying the risks of vaginal mesh complications to protect profits.

Patients who have reported serious injuries in conjunction with vaginal mesh complications including but not limited to:

• Painful Intercourse
• Urination Problems
• Occurrences of Pelvic Organ Prolapse
• Vaginal Scarring
• Bladder Infection
• Perforated Pelvic Organs including: Bowls, Bladder, and even Blood Vessels
• Mesh Erosion in the Vagina
• Mesh Infection
• Device Failure
• Mesh Tearing
• Internal Organ Damage

These vaginal mesh complications have forced many women to undergo revision surgery to explant or replace the product, in order to resolve these problems. However, revision surgery is considered riskier than the initial implant procedure, due to higher risk of infection.

Many of these vaginal mesh devices were approved through the FDA’s 510(k) process, which allowed the devices to bypass rigorous testing requirements. As long as the device proved to be “substantially similar” to another product already released on the market, the FDA may grant approval. Critics have alleged that the 510(k) process allowed for unreasonably dangerous products to be released.

Carol’s TVT Abbrevo lawsuit is joining an MDL, where it will stand alongside other claims alleging similar injuries. The TVT Abbrevo Lawsuit is Case No. 2:17-cv-03736, in the U.S. District Court for the Southern District of West Virginia, Charleston Division.