A Wisconsin patient says that she was implanted with a Gynecare TVT Obturator System made by Johnson & Johnson and Ethicon, and claims that a defect in the device’s design caused her injury.

Plaintiff Helen F.’s transvaginal mesh lawsuit states that she was implanted with the Gynecare TVT Obturator System in a surgery performed in Wichita, Kan. on or around Aug. 7, 2015. According to Helen, this device was implanted to treat her for stress urinary incontinence (SUI) and other symptoms.

Allegedly, the purpose of her procedure was consistent with the purposes “for which the product was designed, marketed, and sold.” She says, however, that she was injured by the device and had to undergo revision surgery. The device was removed in Wichita in January 2016.

What is Transvaginal Mesh?

Surgical meshes in general are medical devices that are used to provide extra support to weakened or damaged tissue. Mayo Clinic notes that transvaginal meshes are surgical meshes used to treat pelvic organ prolapse (POP), a condition in which pelvic muscles and organs weaken, and the organs can slip out of place. Transvaginal mesh can also be used to treat stress urinary incontinence, a condition when a person’s bladder is not strong enough to withstand normal pressure, causing a person to urinate when coughing, sneezing, running, or lifting heavy objects. 

Plaintiff TVT Mesh Lawsuit Complaints

Helen aims to hold both the manufacturer and subsidiary company accountable for her injury. Gynecare manufacturer Ethicon produces pelvic floor medical devices for women; they are owned by Johnson & Johnson. Helen claims that the companies knew or should have known that the device was possibly harmful, but released it into the stream of commerce nonetheless.

According to Helen, if the companies had properly represented the products as dangerous, she would not have agreed to have the product used in her surgery, and would have instead chosen to use a different product. Thousands of women who suffered similarly feel the same.

Her transvaginal mesh lawsuit says that because of the Gynecare TVT Obturator System, she experienced significant mental and physical pain, disability, and suffering. Additionally, she says that the injury and disfigurement she suffered because of the device will be permanent.

In addition to physical injury, Helen alleges she suffered emotional pain and loss of income and expenses related to her condition. She also argues that she has “endured impaired physical relations during intimacy,” among other damages, as a result of the device’s alleged defects.

The transvaginal mesh lawsuit claims that Ethicon and Johnson & Johnson knew that transvaginal mesh products could cause injury, but advertised their products as safe and effective in an effort to maximize their product sales. Allegedly, the FDA issued a Safety Communication in 2011 that stated that there were “serious complications associated with surgical mesh” for transvaginal conditions, and noted that there was not a notable advantage to using mesh as opposed to other methods to treat pelvic issues.

Later, concerns over transvaginal mesh have been spread more widely, and have caused public concern. In 2015, Women’s Health noted possible complications with the device, noting that it could be dangerous despite its rising popularity. The FDA has had mesh products reclassified as Class III, high risk medical devices.

The Transvaginal Mesh Lawsuit is Case No. 3:19-cv-00030-slc, in the U.S. District Court for the Western District of Wisconsin.