SAN DIEGO – Attorneys defending Johnson & Johnson sought to establish that doctors don’t bother with IFUs (instructions for use) that come with pelvic mesh kits in a trial to decide if the company allegedly sold the devices knowing they were harmful.
“What is done with the IFUs from the kits?” asked William Gage, an attorney for Johnson & Johnson.
“I have no idea,” responded Dr. Karyn Eilber, a female pelvic medicine specialist. “They’re probably thrown in the trash.”
“To what extent have you seen doctors review the IFUs?”
“I haven’t seen any,” she said.
A central position of attorneys for the California Attorney General’s Office is that IFUs in mesh kits did not contain important information explaining the complications that could come from a pelvic implant, such as life-changing and long-lasting chronic pain or pain with intercourse. They alleged that Johnson & Johnson downplayed the risks in the IFUs to sell the devices to doctors.
The trial in the San Diego Superior Court is being streamed live courtesy of Courtroom View Network.
Eilber said her complication rate after implanting the mesh devices in women is low, around 2 to 3 percent.
“To what extent have patients experienced chronic dyspareunia (painful intercourse)?” Gage asked.
“I have not had anyone with chronic dyspareunia, fortunately,” Eilber said.
“What about native tissue repair for pelvic organ prolapse (POP)?”
“I can’t think of any that are chronic,” Eilber said. “There have been some who had (pain) for a period of time. If a person is having pain with intercourse, I’m very aggressive to treat and get rid of it.”
Eilber called mesh the “gold standard” for treatment.
State attorneys called to strike the gold standard comment. Judge Eddie Sturgeon overruled the objection.
Eilber said since mesh was withdrawn from the market, other techniques have been used such as sacral colpopexy, a surgical procedure near the abdomen she indicated is a more-involved procedure than using a mesh kit.
“It (colpopexy) has a higher potential for complications,” Eilber said. “If it’s done in experienced hands, it’s safe. But (with mesh) you’re not near the same organs.”
On cross-examination, attorneys for the state questioned Eilber about a range of possible complications from a mesh implant.
“You would agree it (complication) can result in an altered body, self-blame and shame?” the state’s attorney asked.
“Yes,” Eilber said.
“Reluctance to seek (medical) care?”
“Yes.”
“Women can develop chronic pain?”
“Yes.”
“Altered body situations?”
“Yes.”
“Changes in sexual intimacy?”
“Yes.”
“You would agree mesh complications can lead to pain every single day?”
“Yes, I suppose so.”
“Sex with a husband feeling pain, right?”
Eilber agreed.
“A woman who has undergone multiple corrective surgeries to treat mesh-related complications, her life may be changed for the worse, right?”
“Yes.”
The state of California, through its Attorney General Xavier Becerra, sued Johnson & Johnson over its pelvic mesh devices, including one called Prolift, designed to support a sagging bladder or alleviate incontinence. Prolift is a clear polypropylene mesh with several thin connecting arms.
Made by its subsidiary Ethicon, attorneys for the state allege the devices caused vaginal injuries in women. They also allege that Johnson & Johnson sold the products through the use of deceptive marketing practices. The company reportedly sold 42,000 Ethicon pelvic mesh devices between 2008 and 2014.
The trial began on July 15.