Surgeons lacked caution in use of vaginal mesh implants, doctor admits
The corporate giant Johnson amp; Johnson says it acted “ethically and responsibly” in developing and selling its controversial transvaginal mesh implants, which have left hundreds of Australian women with chronic and debilitating pain.
A Senate inquiry is currently examining the impact of transvaginal mesh products, which are used to treat urinary incontinence and pelvic prolapse, common complications of childbirth.
The devices have caused lifealtering complications in many cases, leaving women in severe pain and unable to have sexual intercourse.
The inquiry heard from two women whose lives have been destroyed by post-surgery complications – Gai Thompson, who had her surgery in 2008, and Joanne Maninon, who had the device implanted in 2012.
Both struggled with tears as they spoke of the impact the devices have had on their lives.
Maninon said she was told the mesh would make her feel like a “16year-old virgin” and that she would be back at the gym in 10 days.
“To this day, I can’t sit upright on a chair for longer than 15 minutes at a time due to the searing, burning pain that travels across my lower abdomen and into my pelvis,” she said.
Maninon was completely bedridden for 14 weeks due to the agonising pain. She wasn’t able to leave the house for months. To get to the doctor, Maninon lay down on a mattress in the back of a station wagon.
“I describe my pain as being cut open and set alight,” Maninon said. “A deep burning, searing ache that intensifies with movement.”
Later on Monday, the inquiry heard from Gavin Fox-Smith, the managing director of Johnson amp; Johnson Medical Australia and New Zealand.
Fox-Smith offered an apology to “patients who have not experienced a successful outcome from their treatment”.
But he said he believed the current Australian class action against the company would vindicate its actions.
“We believe the evidence will show we have acted ethically and responsibly in the research, development, and supply of the products that are the subject of the proceedings,” Fox-Smith said.
Asked whether the victims’ stories had affected him personally, Fox-Smith replied:
“Thats a pretty personal question senator, so I’ll give you a personal answer,” Fox-Smith said.
“It’s really, really hard to even conceptualise the challenge that the patients are facing. And for me, honestly I’ve had the privilege of working in this industry for 30 years. Our job is to make patients better, so for me it’s really tough, it’s nowhere near as tough as what the patients have to deal with,” he said.
Earlier, Urogynaecological Society of Australasia director, Jenny King, told the inquiry there had been a lack of caution around the use of the devices. Surgeons, she said, thought they were “magic”.
But King labelled any attempt to ban the controversial devices as “hysterical”, saying they had positive outcomes for women who were unable to undergo other major surgery. She instead said doctors should be more careful in their use, avoiding operations on younger and healthy women.
“The impacts that these have had on these women – we have seriously let them down,” King said.
“But what phases me about this is the suggestion that the solution is to ban vaginal mesh products so that other people don’t suffer,” she said.
“I don’t want to defend all of my colleagues, but we’re not really callous. We don’t like it when we can’t fix everyone, we’re really bad at that.”
Estimates vary on the number of women who have experienced problems with the implant. King said about 5% of cases caused problems. Other estimates suggest a higher rate of 10-15%.
The use of the mesh had dropped by 90% in recent years, since concerns became public.
King said the controversy had made her “timid” in her use of the devices. She regretted not using the mesh in some circumstances, because it required women to eventually undergo multiple surgeries.
The cases, seen across the western world, have prompted significant criticism of manufacturer, pharmaceutical giant Johnson amp; Johnson. The company is currently being sued in a class action in Australia.
The Australian trial has heard the company embarked on an aggressive marketing campaign to sell the products to surgeons, promising they were easy to insert, inexpensive and therefore lucrative. Advertisements associated the products with Lamborghinis and trips to the Swiss Alps.
The risks of the devices were downplayed and controlled trials were either nonexistent or insufficient, the court has heard.
The court also heard the company tried to stop French health authorities publishing a report warning against the use of its untested pelvic mesh devices, two years after they began giving them to Australian women.
Senator Derryn Hinch, who has campaigned against the mesh devices, asked King if Australian surgeons were offered incentives to use the devices.
“No love, truly I’ve never seen anything like that,” she responded. “Nobody’s ever given me one. I would hate to think that had happened, and I don’t know of it, truly.”
The inquiry is considering several courses of action on the mesh. One is to ban the device outright. Another is to introduce a mandatory reporting regime, which forces doctors to report adverse impacts on patients. The inquiry heard there was significant under reporting of adverse consequences on women.
A third is a credentialing system, which would ensure surgeons were appropriately qualified to conduct such surgeries.
It is also considering a recommendation to build a tracking database to monitor the use of different mesh products on patients.
This week it was revealed that Johnson amp; Johnson pulled two controversial pelvic mesh devices from the Australian market.
The decision came after Australia’s Department of Health required further evidence of the devices’ safety.