SAN DIEGO – A San Diego County woman recalled her suffering after a vaginal mesh implant was performed and a doctor said the mesh sometimes appears deformed upon removal, in a trial accusing Johnson & Johnson and its subsidiary Ethicon of providing defective injury-causing incontinence devices.
“It (mesh) appears deformed and smaller than when it came out of the (Kit) box,” Dr. Bruce A. Rosenzweig, a gynecologist and urinary tract specialist with the Rush University Medical Center in Chicago, told the court on Tuesday.
The trial in the Superior Court of California Central Courthouse is being streamed live courtesy of Courtroom View Network.
The State of California through its Attorney General Xavier Becerra is suing Johnson & Johnson over a pelvic mesh device called “Prolift,” made by subsidiary Ethicon, for allegedly causing vaginal injuries in women and for selling the product by the use of deceptive marketing practices. Prolift appears as a clear polypropylene mesh with eight thin connecting arms.
Since 2012, numerous lawsuits have been filed by individual women who had mesh devices implanted who later alleged they suffered intense pain and side effects that required the devices to be surgically removed with great difficulty.
Washington State sued Johnson & Johnson earlier this year in a similar case but the company agreed to pay $9.9 million to settle with no admission of wrongdoing. The case at trial in San Diego is the first filed by a state attorney general over the implant devices and seeks damages under unfair competition and false advertising laws.
The company reportedly sold 42,000 Ethicon pelvic mesh devices between 2008 and 2014, designed to help a sagging bladder condition called “pelvic organ prolapse” or POP.
In a deposition filmed in 2015, Coleen Perry, a resident of Tehachapi, Calif., told the court she experienced vaginal pain after having a mesh implant performed in 2011.
“The pain is always there,” she said. “It feels like my tissue is tearing.”
She said the pain could be moderate or severe.
“What triggers it (pain)?” she was asked.
“Things like bending, lifting, doing house cleaning make it worse,” she said.
She added that every aspect of having sex resulted in pain.
“It feels like glass is shredding me,” Perry said. “It’s beyond painful it’s impossible to finish (sex).”
Perry’s husband Patrick, a retired firefighter, said he and his wife used to be an active couple but no longer.
“She’s deteriorating and she doesn’t complain,” he said. “I ask her what hurts and she doesn’t tell me, I have to get it out of her."
He was asked how the situation had impacted his wife emotionally.
“She cries,” he said. “She believes it’s her fault (mesh implant). We are traumatized over the whole thing.”
However, defense attorneys for Johnson & Johnson gained agreement from Coleen Perry that she had been warned and signed a consent form acknowledging complications might result from the implant procedure.
In addition, defense attorneys showed her photos of a trip she took with her husband to Hawaii in 2012 in which the couple had played golf, swam and did zip-line riding.
A letter she had written to a doctor in 2013 titled “A Success Story,” had stated that she was happy with the treatment she had received to date.
Perry said she originally did not know about the Ethicon brand, and that she had been influenced to come forward (litigation) after seeing a television commercial listing the painful symptoms of mesh complications.
“I had all those (symptoms) and decided to make the call,” she said.
Rosenzweig said he stopped using the prolapse mesh devices in 2009.
“Because of the complications,” he said. “There was severe pain and dyspareunia (painful intercourse). These were very difficult to treat.”
Rosenzweig said he did mesh removals if the mesh had eroded in the vagina or if there was active infection caused by the implant, or an obstruction blockage of the vagina or rectum.
“You have to have an indication to do a removal and it can create a new problem,” he said. “To remove (mesh is very complex). It’s hard to find the mesh and take it out.”
He added sometimes a smaller portion of the mesh can separate from the rest and have to be removed.
Rosenzweig said mesh during removal can appear to be curled, deformed, narrower than it was when it was installed. He said the mesh can seem like a rubber band that snaps when you cut it.
In addition to deformation, Rosenzweig said chronic foreign body reaction can result from the implants, and inflammation caused by the body's attempts to rid itself of a foreign invader (the mesh).
San Diego County Superior Court Judge Eddie Sturgeon is presiding.