Sunday, January 01, 2012

Breast implant scandal: the whistleblowers - Telegraph


Mr Brook Berry wrote in his letter: “That a high cohesive gel implant could have suffered such a massive failure only three years after implantation is very worrying ... the reliability of PIP implants must be questioned and, for myself, I intend to discontinue their use in favour of implants from other manufacturers.”
At his home close to the Pyrenees, Mr Berry told The Sunday Telegraph last week: “I was issuing a warning. That is absolutely what I was doing. I am horrified by this. I am amazed it has taken so long to uncover.
“These PIP implants were just that bit cheaper which is why the NHS and many private hospitals started using them. We believed they were as good as anything else on the market. But then I had this case – and another one – of ruptures which both presented with silicone in the lymph nodes. Putting the two cases together I stopped using PIP and I wrote my letter with my advice to stop using them. Part of the job is to share with colleagues the concerns that you have.”
The problem, he added, was the British regulator – then the Medical Devices Agency (MDA) – didn’t seem to care. “It was never very interested in these things,” said Mr Berry.
A year before, in 2006, Ruth Waters, a surgeon at Selly Oak Hospital in Birmingham, had witnessed the same problem in a 45-year-old woman, who had received implants at a private cosmetic clinic.
“The failure of the implant was nothing I had ever seen before,” she recalled. She was so alarmed that she too wrote a case report, published in the same journal.
She had never come across PIP implants before, and had urged her patient to sue the manufacturer and the clinic for negligence.
Mrs Waters had no way of knowing the PIP implant was systemically faulty.
“It is terrible this has taken so long for this to emerge,” she said last week. “By writing it up, that was the best way to disseminate the information.”

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