Edith Rumler had no idea the breast implants she had fitted in 2007 were the same ones recalled worldwide in 2010, after health authorities found some contained industrial instead of medical-grade silicone.
But it wasn’t for lack of trying. When she heard the PIP brand of implants were rupturing and causing a range of medical problems, she tried to contact her Sydney surgeon to find out if she had been given the same ones.
“I rang them five or six times in a week and left messages, but I never heard back,” she said.
Defective silicone gel breast implants manufactured by the now-defunct French company Poly Implant Prothese (PIP). Photo: Reuters
“So I went to my GP and he wrote a letter to my surgeon on my behalf saying I had to be seen regarding my breast implants.”
By the time the surgeon’s clinic rang Ms Rumler back, she had already been through all of her paperwork and found the answer on her own. There, on one of her medical forms, she saw she had received the PIPs.
“Deep down, I suspected I had them, because I had been in so much pain from about six weeks after I first had the surgery,” she said.
PIP implant victim Edith Rumler.
“My body would break out in rashes that spread like wildfire, I would get welts the size of 50-cent pieces, and I was in so much pain that I could barely lift my arms.”
Despite all those symptoms, she was never told she had to have the implants immediately removed prior to the PIP breast implant outcry.
But when the scandal broke and she eventually realised she had the brand, she began saving up for removal surgery, finally having them taken out in 2012.
The rash Ms Rumler began getting following PIP implant surgery.
“I only had small B-cup implants put in to begin with, but when they were taken out they were almost completely flat,” she said. “So much silicon had leaked out of them.
“When the surgeon saw them he said they were too small to be B-cups, that I must have been mistaken, even though I had the paperwork from the original procedure.”
Ms Rumler is one of many Australian women who has joined a new global class action claim against TÜV Rheinland, the German company who certified the PIP implants. Other women affected by PIPs worldwide are being urged to join before registration closes at the end of the week.
For many women it offers new hope after Australian law firm Tindall Gask Bentley withdrew their class action in 2012 after it was revealed the proposed defendant and distributor of the implants, Medical Vision Australia Pty Ltd, had limited product liability insurance.
What the PIP breast implant scandal ultimately exposed was a disturbing lack of recorded data around the high-risk medical procedures.
Though Australia’s drug regulator, the Therapeutic Goods Administration (TGA), recalled the implants, there was no way for them to determine exactly how many Australian women had received PIPs or who they were.
That data isn’t routinely collected.
Yet as of May this year, 530 PIP ruptures had been confirmed in Australia through MRI scans and surgery, with new cases cropping up regularly.
But the Department of Health has confirmed work on building a national breast implants register will finally begin later this year, due to be completed in 2015 and almost four years after the scandal first began.
A Department spokeswoman said the breast implant register would be set up along with a separate cardiac devices register at a cost $12.1 million over four years.
Monash University, which has already piloted a breast devices register in South Australia and Victoria, has put in a bid to build the national database.
Custodian of the pilot register, Professor John McNeil, said a national registry would give Australia an opportunity to show leadership in recording medical data, with many medical device registries overseas failing because they were overcomplicated or opt-in.
“Registries are becoming so important for so many reasons, not only for showing the safety of devices but to help identify any variation in procedures and outcomes,” he said.
“In this way, the can also help to establish the credibility of surgeons.”
Along with the breast implants register, a national patient contact protocol will be complete by the end of 2015 subject to approval by all jurisdictions. It will mean patients can quickly be identified and alerted in the case of a future PIP-like event.
Ms Rumler said such a register and protocol for contacting patients would have “significantly” changed the outcome of her case because she would have gotten them removed sooner.
“Even now there are women out there who don’t know which brand of implants they have,” she said.
“And even though I have now had mine taken out, I will never be the same. The pain was unbearable.
“Let’s hope this type of problem never happens again, but if it does, women should get notified immediately and not find out years later when something goes wrong, or by having to chase their surgeon for information.”
The TGA agreed to the measures last year after findings from a Senate Inquiry into the scandal were handed down. Now, a timeline for the measures is in sight.
But the Inquiry wasn’t the first time better recording of such procedures was pushed. Findings from a government review into health technology back in 2010 recommended improved surveillance of medical devices as well.
And along with the PIP ruptures there have been other breast implant scares. Claims against American manufacturer Dow Corning and involving Australian women date back to the 80s.
Just this February, fears were raised that Australian women who had their PIP implants taken out may have had them replaced with a second, now recalled brand, Cereform. Concerns about the sterilisation of those implants, are yet to be resolved.
Following such a high-profile scandal as PIP, a national breast implants registry and protocol will no doubt help thousands of women who undergo breast implant procedures in future to feel more confident in their decision. And if disaster occurs, at least no woman will remain unidentified.
But it’s a measure from the TGA that is long overdue.