NHS patients believed to be among faulty French breast implant victims
It has also emerged that 250 women with silicone breast implants made by Poly Implant Prothese are suing six UK clinics
At least 250 women with breast implants made by the French company at the centre of a scandal over faulty implants containing industrial silicone intend to sue at least six clinics in the UK, it emerged yesterday.
About 40,000 women in Britain have had silicone breast implants made by Poly Implant Prothse (PIP), possibly including hundreds who have had reconstructive breast surgery on the NHS.
Details of the legal action emerged amid reports in France that up to 30,000 women may be told to have defective implants removed. French authorities shut down the manufacturers last year and supplies were stopped in this country after the company was found to be cutting corners and making breast prosthetics from cheaper industrial silicone normally used in electronics. The implants were also found to have a higher chance of bursting.
The scandal deepened in France this week when health officials reported eight cases of cancer in women who had received the implants.
The Department of Health tried to stop any panic. It said the Medicines and Healthcare products Regulatory Agency (MHRA) had held discussions with other health or regulatory experts from France, the Netherlands, Portugal, Italy, Ireland, Hungary, Austria, Denmark and Malta. "They all agreed that there was no evidence of any increase in incidents of cancer associated with PIP breast implants and no evidence of any disproportionate rupture rates. This is in line with UK findings."
The DoH said there was no evidence to support the routine extraction of the implants. "We would urge any patients with any concerns about their breast implants to seek advice from their surgeon," said a spokeswoman. "Any decision on funding the removal of these implants would be determined on a case-by-case basis according to clinical need."
Safety watchdogs said "very few (less than 5%)" of Britons involv! ed would have had state-funded operations on the NHS using the implants behind the scare. The "vast majority" would have received their implants in the private sector for breast augmentation, the MHRA said.
Based on reports to the MHRA, it is believed that about 1% of women in the UK with PIP implants have suffered implant failure, including rupture, said the department. This was lower than data from the French medical device regulatory authority Afssaps, which suggests a failure rate of about 5% in France. Many women with PIP implants are said by lawyers in the court case to have experienced "agonising problems, including ruptures and leakages".
Mark Harvey, a partner at Hugh James solicitors, which is pursuing the legal action, said: "We wanted to pursue claims against PIP or its insurers. It is quite clear that is not viable."
Instead, he said, the women would be pursuing action against clinics and more might still be included in the case. The court hearing in Cardiff next month would be for lawyers to apply for a group litigation order so that a class action could be launched. Clinics had entered into contracts with women, promising the implants would last a lifetime and would not rupture or leak silicone, said Harvey.
Although implants cost only a few hundred pounds, the surgery itself cost several thousands. "We have spent a lot of time trying to persuade clinics to resolve the matter without going to litigation," Harvey said. "That has not worked so far."
Some of his clients had complained of inflammation, fatigue and fibromyalgia, a musculoskeletal pain disorder. "Whether it is ultimately linked, we don't know," Harvey said. He added: "The NHS has come to the aid of some of the women where there was clinical need." Understandably, he said, the NHS was not prep! ared to pay for replacements.
The largest maker of breast implants in the UK, Nagor, said it had already provided free implants for about 20 UK women with ruptured PIP devices. They usually cost about 700 for a pair. Douglas Black, Nagor's national sales manager, said: "There are a lot of patients out there, worried and panicking."
He believed companies, hospitals and clinics, and surgeons might help women reduce the costs of replacements. "I want to get together that group to see what we can to help as many as we can."
In France, the newspaper Libration newspaper reported that the French health ministry was preparing to tell all women with PIP implants that medical and surgery costs linked to removal, including scans, analysis, removal of implant, and post-operative tests, would be refunded. Women who have had reconstruction surgery after breast cancer will also be reimbursed for replacement implants.
Eight cancer cases among women with PIP implants were announced last week by Professor Jean-Yves Grall, director general at the French health ministry. Five of the eight were breast cancer. One woman had died of anaplastic large cell lymphoma, a rare cancer that affects cells from the immune system. Afssaps said it had not established a cause-and-effect link between implants and cancer.
One woman's story
Amanda Harrison had faced years of bullying at school for being flat-chested and in her mid-30s she finally decided to do something about her appearance. "I wanted to be normal and wear normal clothes," she said. So in August 2006 she paid a London clinic 4,259 for implants. "Everything went fine and I was really pleased with the results," said Harrison, now 40, from Ramsgate, Kent. "A couple of years later, I began to feel generally unwell. In February 2009 I suffered a severe kidney infection and I was in hospital for eight days. I went through tests, scans, everything. My kidney was very enlarged and they gave me antibioti! cs."
Her three months off work was the first of many from jobs first as an area sales manager for a local paper, then part-time advertising and marketing co-ordinator for a local garden centre. Other health problems followed and in July 2009 an ultrasound confirmed a small lump on her breast tissue. Harrison's surgeon thought it was caused by the implants and would need to be removed if it grew larger. In August, it was removed. "They said they thought it was scar tissue."
Breathing problems, severe tonsillitis and upper respiratory difficulties followed. as doctors struggled to establish diagnoses. Early in 2010, Harrison had heart palpitations. An electrocardiogram could find no obvious reasons.
"In January this year , I noticed my right breast was ever so slightly smaller than my other breast." said Harrison." I didn't do anything at the time, because a few days later, I was struck by a horrendous illness which started as tonsilitis but got worse and worse. In March I was admitted to hospital with suspected viral meningitis."
In March this year, Harrison spent a week undergoing a battery of further tests. They showed enlarged lymph nodes and bulging discs on her spine. "I had physio for that but it did not work." Her illness was diagnosed as viral. By May she had chronic fatigue syndrome; and was given medication and anti-depressants. In June she had a tonsillectomy.
Then Harrison rang the clinic where she had her implants fitted because she wondered if there was a link. A receptionist told her to get her GP to refer her for an MRI scan because her implant might be ruptured. Harrison googled her symptoms and found coverage of the PIP affair in France. "I had been blissfully unaware of this thing."
The scan at an NHS hospital found the implant in her right breast was indeed ruptured. "My GP thought my symptoms might be down to that," says Harrison, and in September she went back to the clinic. "My surgeon was absolutely fantastic. He has been very supportive." He operated an! d remove d the implants free of charge, although the clinic made her pay other fees including the anaesthetist those and replacement implants cost 1,500.
"I feel terrible. I am off work again. I have no energy. I cannot concentrate. I have this brain fog. I have had another MRI scan in the last week." Harrison said her surgeon had told her silicon from the PIP implant had migrated into the breast tissue and that was what was making her ill.
"I think hundreds of other women out there are experiencing the same symptoms and don't know if this might be linked to their implants ... If I could turn back time now I would never have had it done."
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