According to the claims of plaintiff Linda Gross in the New Jersey Superior Court trial against Johnson & Johnson’s Ethicon over vaginal mesh complications, “Ethicon never conducted human tests of the mesh implant kit that the plaintiff claims hurt her.”
The subject of this lawsuit is the Gynecare Prolift device, which is the type of vaginal mesh kit that the plaintiff in the case was given. Her lawsuit states that the device she was given was a pre-cut piece of mesh that generally comes with its own kit that helps doctors with the implant procedure. The plaintiff is claiming that her device did not actually come with this kit that was marketed to doctors for the purpose of human testing. This is one of the main claims in her lawsuit and a point that the jury in her case has been reminded of repeatedly so far.
In fact, the plaintiff’s lawyers have kept the lack of clinical trials in the jury’s mind by bringing it up during questioning of witnesses, which include Scott Ciarrocca, the executive in charge of the Ethicon team responsible for bringing the Gynecare Prolift to market; Dr. Piet Hinoul, Ethicon’s medical director; and Dr. Charlotte Owens, the Ethicon doctor in charge when the Prolift was first put on the market.
For its part, Ethicon says that before the company started marketing the Prolift device, it tested the Gynemesh PS, which is the mesh that was included in the plaintiff’s kit. The company stated that during the tests, it found that the mesh was not in the same shape that it was in when it was given to the doctors in the prolift kit. Instead, they say that the mesh was in a square so that the doctors could cut it into whatever shape that worked best with their tools. One doctor, Dr. Anne Weber, who was the urogynecology expert for the plaintiff’s side, stated that the company’s dependence on the performance of the Gynemesh PS’s performance didn’t make any sense because the procedure kit for the Prolift device caused a whole new set of difficulties that Gynemesh PS doctors didn’t have to deal with.
Vaginal mesh devices like Ethicon’s Gynemesh Prolift implant have undergone scrutiny for some time now after the devices were found to cause serious complications that required surgical removal. Some of those complications include erosion, vaginal scarring, painful intercourse and infections. These have caused many patients to file lawsuits against the manufacturers of the devices.