The start of January 2012 saw the health scare and scandal over the French made PIP breast implants literally blow up in the national media and the Houses of Parliament as more and more data, patients and surgeons questioned the exact nature of the threat that the industrial grade components posed and just who was responsible, who should fix it and what could be learnt.
It’s almost a whole two years since in March 2010 French authorities first suspended the marketing, distribution and export of PIP (Poly Implant Prostheses) breast implants following the discovery of irregularities in the composition of the silicone gel and outer shell which comprised the implants. (See our original blog as the news broke.) It is only now starting to come to light that there was something distinctly criminal going on as more tests are carried out on the implant material, French legal authorities investigate and the full extent of use of the adulterated implants is learned by UK and EU governments.
Debate now rages on whether implants should be removed and replaced in patients as a matter of urgency or whether the risks of them remaining are equal to or less than those involved in a repeat surgical procedure or those of any other breast implant. Add to that the cost and who pays it; France has stuck its neck out and said the government will pay, here many argue that private clinics who used these cheaper implants should foot the bill, yet many surgeons and clinics want to charge the patients themselves, at least for the hospital costs involved, or get the government to pay. Much attention is being focused on rupture rates which range dramatically with data from the Medicines and Healthcare products Regulatory Agency (MHRA) quoting 1%, France 5% and Transform Group, the UK’s largest cosmetic surgery chain quoting its own data as showing 7%. Until a consensus could be established on a risk of rupture and whether this is any worse than established and valued brands of breast implants, no decision was being made by UK authorities on removal advice, despite the proven industrial grade contents of the implants.
Globally more than 300,000 PIP breast implants are believed to have been sold to 65 countries over the last 12 years, more than half of those went to South America. In the UK it is estimated to affect some 50,000 women. It has now also emerged that PIP implants were sold to a now bankrupt Dutch company and rebranded at Rofil-Medro or Rofil-M implants, estimated to affect a further 5,000 UK women. Additionally, many Brits who chose to go abroad for cheaper surgery to countries such as Belgium, Poland and the Czech Republic may also have received PIP implants by one name or another and be unaware of it. The majority of patients treated in the UK were clients of Transform Group. Harley Medical Group, The Hospital Group and Linia.
After the initiation of a speedy government review by the Secretary of State for Health, Andrew Lansley in conjunction with an expert group consisting of plastic surgeons and other scientists, a request was issued for clinics involved to submit data within 48 hours, pending a decision from the Department of Health which came at 5pm on Friday 6th January, (report available here in PDF format).
In a statement, they said, “the group has concluded that the advice given by the MHRA still stands and that there is not enough evidence to recommend routine explantation of these breast implants.”
However, health officials in France, The Netherlands, Germany, the Czech Republic and Venezuela have already advised women with PIP implants to have them removed.
In relation to those women wanting to have the implants removed and replaced it said; “the NHS will replace the implants if the original operation was done by the NHS. We expect the private sector to do the same for their patients.”
The health service has therefore clearly laid down the gauntlet and asked the private sector to bear the cost for those patients that it treated; it also plans to pursue those who won’t treat patients by saying; “If a clinic that implanted PIP implants no longer exists or refuses to care for their patient – where that patient is entitled to NHS services, the NHS will support the removal of PIP implants. Any NHS service in that respect would not include the replacement of private cosmetic implants. The Government will pursue private clinics with all means at its disposal to avoid the taxpayer picking up the bill.”
A statement by NHS Wales went further by saying that if it were to do operations on patients previously treated privately, that it would also replace the implants at the same time to avoid a need for a further operation for implantation for the patient at a later date.
In response to this, some of the larger cosmetic surgery chains such as Harley Medical Group who used PIP implants are refusing to absorb the cost of removal and replacement (unless a rupture has occurred) and are openly telling patients how much it will cost them, as they believe that the government is liable, through the MHRA, for regulating a medical device as fit for use which they took on good faith and implanted into patients, hence they are of the opinion that it should foot the bill and not them. Chairman of The Harley Medical Group, Mel Braham, whose chain of clinics carried out the largest number of PIP implant operations (13,900 between September 2001 and March 2010) went as far as to say it would bankrupt his company if they had to replace all PIP implants for all patients treated free of charge.
One person who also agrees that the MHRA should be accountable is well known TV Doctor, Dr. Hilary Jones who said following Andrew Lansley’s announcement that it is not the private clinics who are to blame for using PIP implants, which were regulated and approved for use by the government body the MHRA. In a statement he said;
“...it's important for everyone to remember that all medical professionals used the government regulated PIP implants in good faith. Hundreds of nurses and surgeons in private clinics are distressed at the implication that they used a cheap implant and the idea that they are at fault for using what was a government approved product. It seems apparent that PIP Implants were widely used in the NHS, in many private hospitals whose operating surgeons includes BAAPS members, by private Plastic Surgeons and larger clinic groups, with the full approval from the MHRA.”
Other providers including BMI Healthcare, Nuffield Health and Spire have agreed to offer free removal of the PIP implants. Implant manufacturer Nagor is also offering free replacement implants.
Many patient campaign and support groups have also been set up in light of this scandal and legal teams from a variety of national solicitors are openly advertising their services to act for those affected by this specific product.
Health Secretary, Mr Lansley is now coming under pressure by MPs, industry associations, patients and clinics to offer a more decisive and clear approach to the situation for all concerned.