Publications
Partners
- A group of women will bring a class action lawsuit against a Danish pharmaceutical company over harm that an implant has allegedly caused.
- The implant, a trans-vaginal mesh, is used to treat urinary incontinence and other issues.
- But there are allegations that they have suffered long-term harm after having it implanted.
A dozen women in South Africa are following counterparts in Western countries in suing pharma companies for chronic harm they say was inflicted by implants designed to treat incontinence and other ailments.
The polypropylene device, called a trans-vaginal mesh (TVM), is designed to work as an internal support to treat urinary incontinence and displacement of pelvic organs - called prolapse - which most commonly occur after childbirth.
But thousands of women say they have suffered long-term damage and pain after having the mesh implanted, resulting in several lawsuits against various companies.
The South African group is bringing a class action suit against Danish medical device manufacturer Coloplast and Ethicon, a subsidiary of US pharmaceutical giant Johnson & Johnson.
Their representatives on Monday said they intend to launch the case - the first action against TVM in Africa - by August.
"We have been approached by multiple women who have been implanted with what we believe are defective trans-vaginal mesh implants manufactured by these two companies," Zain Lundell, an expert in class-action litigation working on the case, told AFP.
READ | Covid-19 vaccination: people aged 18-34 to be jabbed from 1 September
The firms are also accused of skimping on performance testing and failing to communicate risks.
If successful, the suit could lay the foundation for compensation claims for hundreds more women in South Africa.
Lundell said:
J&J has already lost class actions in Australia and the United States for injuries caused by its device.
In January 2020, a US judge ordered the firm to pay $344 million (291 million euros) for false and deceptive marketing of pelvic mesh products used by tens of thousands of women in California.
Something 'not right'
One of the applicant, Suzette Roodt, is hoping compensation will help fund a costly operation to remove her own mesh implant.
The device is so imbedded in surrounding tissue that removal requires laser technology that is unavailable in public hospitals, she said.
The 57-year-old had been optimistic in 2015, when a new job allowed her to afford an insert that would help end her long struggle with bladder leakage.
READ | Aspen's Gqeberha plant releases J&J vaccines
But as soon as she was discharged from hospital in 2015, Roodt, "... knew something was not right", she said.
The implant hardened, causing complete obstruction of her bladder as well as frequent bleeding and kidney infections.
"We were never told about the risks or given other options," Roodt, who is now permanently attached to a catheter, said via telephone. "There has been permanent damage to me."
Unlike South Africa, the United States in 2016 classified mesh used for pelvic organ prolapse as a "high-risk device" and banned its sale in 2019.
Complications occur in up to a quarter of women, according to a study by BioMed Research International.
'Need to lie down'
But Chantell Bothma said no such information was communicated to her.
The 41-year-old was offered the implant in 2016 to treat prolapse after giving birth to her first child.
The mesh eroded and melded with her tissue, eventually forcing Bothma to have it removed four years later. She still experiences bladder pain.
"I used to be very active," she recalled. "Now when I play with my little boy I need to lie down."
Bothma was recently hospitalised for an unrelated condition during which she met another woman about to receive a similar implant.
The encounter spurred her to take legal action.
Ethicon told AFP that pelvic mesh has, "... helped improve the quality of life for millions of women".
"We empathise with those who have experienced complications," the company said via email. "Ethicon has acted ethically and responsibly."
Coloplast did not respond to requests for comment.
The case could conclude within three years, Lundell said.
