Faulty PIP breast implants replaced with now recalled brand CEREFORM, hundreds of Australians may be affected
ABC News Online
By medical reporter Sophie Scott and Alison Branley
1 April 2014 18:00 hours
Authorities do not know how many Australian women had faulty French breast implants replaced with a second, now recalled brand.
Last month the Therapeutic Goods Administration (TGA) announced the Australian distributor of PIP breast implants, Medical Vision Australia, had pulled its CEREFORM implants from shelves following a recall in France.
Despite the recall, Medical Vision are still spruiking the product on their website.
The recall occurred after the French regulator found the paperwork around sterilisation did not meet international standards.
In Australia, the TGA said there had been no increase in infection rates with the implants and there was no health risk.
About 4,800 CEREFORM implants have been sold in Australia since 2009 and while only some would have been replacement implants, hundreds of women could be affected.
Among them is Cairns woman Christine STEPHEN, who was never told her CEREFORM implants came from the same distributor as PIP.
Ms STEPHEN had her PIP implants removed after one ruptured.
She developed a severe infection around her replacement CEREFORM implants and had to be rushed to hospital.
“It had to be all scraped out. I didn’t know whether I was going to wake up with or without a breast,” she said.
While she was understanding about the PIP recall, she is angry the CEREFORM implants have also been recalled.
She has spent $25,000 on surgeries so far and needs another operation to remove scar tissue.
“I cannot understand why a product from the same company [sic] and same distributors was allowed into the country and knowingly put into somebody who had been through PIP,” she said.
CEREFORM was distributed by the same company in Australia as PIP but is made by a different company in France.
Ms STEPHEN refutes the TGA’s assertions there has been no increased rate of infections with CEREFORM. She says she had an infection and it was not recorded.
“It just feels like there’s been a lot of lies. And a lot of people passing on blame where it’s black and white,” she said.
Medical Vision Australia did not respond to the ABC’s inquiries.
No figures available on CEREFORM replacements.
Authorities say they do not know how many women in Australia had PIP implants replaced with CEREFORM implants.
The TGA says it does not monitor the sale of approved products and relies on information from surgeons and suppliers.
The Australia Society of Plastic Surgeons says it does not have figures on CEREFORM replacements.
Its president, Dr Geoff LYONS, says the latest recall underlined the need for a breast device registry.
“A world-class registry has been developed in Australia and is ready for national roll-out pending government funding,” he said.
PIP removal process ‘traumatic’ for many women
Lawyer Tim WHITE represents women who had faulty French breast implants, and says the CEREFORM recall was following the same pattern as PIP.
“I expect this is a first step they are using so that if there is a problem it’s not further multiplied by continuing to use the product,” he said.
Mr WHITE has clients who had the PIP implants replaced with CEREFORM. He says the PIP removal process was traumatic for many.
“A lot of the women ended up consulting psychologists because they were that concerned,” he said.
“Some were put on anti-depressant medication. A lot of women took time off work because they weren’t coping emotionally.
“It was a significant impact on many of them.”
Mr WHITE is concerned regulators have not learned lessons from the PIP saga, with no requirement for distributors to have product liability insurance.
“Here you’re dealing with a class three medical device which is a high-risk device according to the TGA,” Mr WHITE said.
“If these implants have to be removed because there is a fault then… it falls to the individual lady to cover the cost out of her own pocket. This is the great concern for consumers in Australia.”
TGA says no identified health risk from CEREFORM implants
The TGA says CEREFORM was recalled overseas because its makers did not comply with regulations.
A spokesman says there is no identified health risk but as a precaution surgeons in Australia were notified and surgeries with the implants were cancelled.
“The TGA is not aware of any increased infection rates among Australian patients receiving CEREFORM breast implants and there is no evidence that any of the implants already supplied in Australia have not been sterilised properly,” he said.
Dr Daniel FLEMING from the Australasian College of Cosmetic Surgery advises the TGA on the implants, and says there is no risk to patients with CEREFORM implants.
“This is a failure of documentation, not a failure of the sterilisation,” he said.
“The TGA is not aware of any increased infection rates among Australian patients receiving CEREFORM breast implants and there is no evidence that any of the implants already supplied in Australia have not been sterilised properly.” A TGA spokesman.
“The importer, the distributor in Australia, has been duped in the same way everybody else has in these matters.”
Dr FLEMING says patients with CEREFORM are at no greater risk of infection.
He does not use CEREFORM implants.
“All patients who have an implant have a chance of infection, about 1 per cent, so of course there are patients who are going to have an infection with CEREFORM implants,” he said.
“But the risk is no greater with CEREFORM.”
The TGA says if there was to be an infection associated with the implant it would follow the initial operation.
Mr WHITE says it also underlines the need for an opt-out breast implant register.
“There’s no process to be able to alert individuals to inform them of this potential problem,” he said.
“There’s certainly been other cases of breast implants failing and so no this is not the second example of it, there’s certainly been others.”
VIDEO: Faulty PIP breast implants replaced with now-recalled brand (ABC News)
PHOTO: Despite the recall, Cereform breast implants are still advertised on Medical Vision’s website (ABC News)
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