In a trial that will determine whether Johnson & Johnson (J&J) knowingly sold a dangerous pelvic mesh device that caused a woman’s injury, a pathologist described how complications can arise with these devices.
Dr. Vladimir Iakovlev, an expert witness for the state and a Toronto-based researcher for St. Michael’s Hospital, said the mesh can distort and migrate in the body after implantation.
Because polypropylene is not inert, he says, the mesh can move through the tissue and “become exposed.” He explained how the nerves surrounding the mesh can be affected and cause pain. Dr. Iakovlev said there’s a higher risk of nerves being affected with mesh devices.
J&J’s legal team claims that Dr. Iakovlev is a “highly paid” witness against the pelvic mesh industry.
Dr. Iakovlev compared the mesh devices to medication in that the side effects can vary greatly among patients. All patients are at risk for complications, he said, but it’s impossible to determine who is at greatest risk.
Dr. Iakovlev explained that inflammation is common as the body attempts to reject the mesh, which it views as a foreign object. The body emits chemicals in an attempt to break down the foreign object, which can cause tissue damage and scarring.
When the scarring extends along the implanted mesh, it creates a “plate-like structure” that continues to fill with scar tissue. This effect, he said, creates a bridge from one fiber to another.
Dr. Iakovlev also explained how the mesh can migrate through tissue even when properly placed. The mesh can change shape, including bunching, curling or folding. These effects can happen immediately after surgery or years later.
California Attorney General Xavier Becerra filed the lawsuit against J&J’s subsidiary, Ethicon, over its Prolift pelvic mesh product for allegedly injuring a woman and allegedly selling the device using deceptive marketing practices.
The lawsuit is the first to be filed by a state attorney general. It seeks damages for allegedly violating false advertising laws and engaging in unfair competition.
Ethicon sold an estimated 42,000 pelvic mesh devices between 2008 and 2014. The devices were designed to help patients with pelvic organ prolapse, or POP.