SAN DIEGO – A Massachusetts gynecologist called as an expert witness by attorneys defending Johnson & Johnson in a trial accusing the company of knowingly selling injury-causing pelvic mesh devices on Tuesday told a courtroom that mesh implants had revolutionized treatments for incontinence.
“It has had such a huge impact on women’s lives,” said Dr. Peter Rosenblatt. “Because of incontinence women wouldn’t play with their children, they were embarrassed to be in public and cough (leak urine). They would change their clothes. To successfully treat them literally changed their lives, they told me this.”
The trial in the San Diego Superior Court is being streamed live courtesy of Courtroom View Network.
The state of California, through its Attorney General Xavier Becerra, sued Johnson & Johnson over the Prolift pelvic mesh device, made by its subsidiary Ethicon, for allegedly causing vaginal injuries in women and allegedly for selling the product through the use of deceptive marketing practices. Prolift is a clear polypropylene mesh with several thin connecting arms.
Rosenblatt outlined for a jury his professional experience in performing implant surgeries of mesh devices and the transformation from earlier procedures such as the Burch procedure in which a bladder is suspended using sutures. Another earlier procedure was the pubovaginal sling in which a strip of tissue is used to form a sling or hammock to support a bladder and urethra.
Rosenblatt said doctors in the 1990s had been disappointed with failure rates with native tissue repairs. He said in addition such procedures ran the risk of scarring and pain complications. The Burch procedure had risks including bleeding, infection, urinary retention and nerve damage. Rosenblatt said it was a more invasive operation involving an abdominal incision.
Gage exhibited a slide that said “TVT slings are safe and effective.”
Rosenblatt said that after 1999 the use of TVT (tension free vaginal tape) increased followed by the subsequent development of the TVT-O or transobturator mesh.
The devices were marketed under a division of Ethicon called Gynecare.
“How many times have you used the mesh for stress urinary incontinence?” asked William Gage the attorney for Johnson & Johnson.
Rosenblatt called the success rate of devices like the TVT-O as “excellent.”
The TVT-O mesh sling procedures Rosenblatt said took less time to perform, 20 minutes, with shorter post-operative recovery involving a smaller incision and minimal risk to the patient.
“It (TVT) was the biggest impact of any (incontinence) procedure in the last 30 years,” Rosemblatt said.
Earlier methods often involved having to do additional surgeries to treat recurring incontinence.
“The best chance of success is with the first surgery,” Rosenblatt said.
Rosenblatt told Gage Ethicon had paid him up to $100,000 per year in consulting fees since the early 2000s and as much as $400,000 over the past four years for his testimony as an expert witness in court.
He said other mesh manufacturers had paid him similar amounts including C.R. Bard Co. based in New Jersey and Massachusetts-based Boston Scientific
The Prolift Gynecare device was introduced in 2008.
In 2012, the Food and Drug Administration ordered further study by mesh manufacturers after receiving 3,874 reports of injuries to women who had mesh devices implanted. Ethicon officials decided to discontinue selling the Prolift, Prosima and TVT SECUR mesh devices.
The case in San Diego is the first at trial by a state attorney general and seeks damages over allegations of unfair competition and violation of false advertising laws.
The company reportedly sold 42,000 Ethicon pelvic mesh devices between 2008 and 2014. The mesh is designed to help a sagging bladder condition called pelvic organ prolapse, or POP. Two of the products at issue are called Prolift and TVT slings.
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