Surgery review welcomed by Blackburn Rovers legend Colin Hendry’s family
6:30pm Thursday 16th August 2012 in News by Jessica Cree, Ribble Valley reporter
DAUGHTER Rheagan Hendry and Denise Hendry
A MAJOR review into cosmetic surgery has been welcomed by campaigner and Blackburn Rovers legend Colin Hendry and his family the government inquiry is being launched in light of the PIP scandal.
Hendry’s wife Denise, 43, died in 2009 after a series of mistakes made during cosmetic surgery procedures. Since then he and his family have campaigned for better regulation.
Daughter Rheagan Hendry said: “My mother was not made aware of the risks. if she had been she may still have been here. There are some plastic surgeons who are just interested in making a sale.”
NHS medical director Sir Bruce Keogh, who will lead the inquiry, said he fears many people do not realise such procedures can have lifelong implications.
the review was requested by Health Secretary Andrew Lansley after concerns about cosmetic surgery were raised following the public outcry over faulty PIP breast implants and could lead to tighter regulation of the industry.
Sir Bruce said: “The recent problems with PIP breast implants have shone a light on the cosmetic surgery industry. Many questions have been raised, particularly around the regulation of clinics, whether all practitioners are adequately qualified, how well people are advised when money is changing hands, aggressive marketing techniques, and what prot- ection is available when things go wrong…
“That’s why I have put together this review committee to advise me in making recommendations to Government on how we can better protect people who choose to have surgery or cosmetic interventions.”
an expert panel, including PIP campaigner Catherine Kydd, former medical director of Bupa Andrew Vallance-Owen and editor of Marie Claire magazine Trish Halpin, will gather evidence before making recommendations to the Government next March.
Members of the public are also being asked to share their experiences of cosmetic surgery and views on issues.
mr Lansley has specifically asked the review to consider implementing a national implant register, for products such as breast implants, to identify all those who received the product and details of their operation.
Fazel Fatah, president of the British Association of Aesthetic Plastic Surgeons (BAAPS), said: “We are delighted that the review is now under way.
“The BAAPS has been campaigning for many years for better regulations of the cosmetic surgery sector to protect patients.”
Government advisers are considering a range of measures for the sector in the wake of the French-made PIP breast implant scandal, which has affected thousands of women in Britain alone.
NHS medical director Professor Bruce Keogh, who is heading a government inquiry, said last week that an insurance scheme similar to that in the travel industry could be introduced for cosmetic surgery patients.
A breast implant registry is also under consideration to record details of all operations.
But the British Association of Aesthetic Plastic Surgeons (BAAPS) wants ministers to go further, warning that lax regulations in the sector has led to a "Wild West" market.
The association called for annual checks on cosmetic surgeons and a compulsory register of all practitioners rather than the current voluntary one for clinics.
It also argued that cosmetic surgery as a medical procedure should not be advertised – similar to the ban that exists on promoting prescription medicines.
The association has long campaigned against what it calls "marketing gimmicks" by cosmetic surgery firms.
BAAPS president Fazel Fatah said that the silver lining in the PIP scandal was that the government had been forced to review the industry.
"we have warned against the unrealistic expectations set by reality ‘makeover’ shows and against crass competition prizes promising ‘mummy makeovers’ and body overhauls," he said.
"we are delighted with the upcoming inquiry and put forward our realistic and achievable proposals for consideration by the government."
Other proposals included a register of all types of silicone implants and dermal fillers, such as Botox, to be reclassified as medicines and subject to tighter rules.
BAAPS also wants a revalidation exercise around products with a CE mark.
The PIP implants at the centre of the recent scandal had a CE mark but were filled with non-medical grade silicone intended for mattresses.
Prof Keogh said the inquiry would look at "all aspects of regulation" but refrained from commenting directly on BAAPS’s proposals.
Cosmetic surgery clinics are claiming that the substandard French breast implants given to more than 40,000 women in the UK are safer than has been alleged, saying that data from thousands of patients shows an acceptably low rupture rate.
The Independent Healthcare Advisory Service, which represents all the major cosmetic surgery chains, is calling on the government’s expert working group, which begins its investigation on Wednesday, to look carefully at new figures it has obtained from an audit of all its members.
The figures, from thousands of patients, show a rupture rate within the accepted norm of 1%-2%, says the IHAS. The organisation is publicly distancing itself from the figures supplied before Christmas by Transform, an IHAS member and one of the biggest cosmetic surgery chains. Transform reported a rupture rate of around 7%, but from a group of around 100 clients, triggering the government inquiry.
“It is vital for patients’ physical and mental wellbeing that policy is based upon clear and reliable evidence,” said IHAS director Sally Taber. “We are concerned that recent reports on rupture rates do not give a true reflection of the situation and are misleading.
“Following an audit of our members, which includes data on thousands of patients from leading groups including Transform, The Harley Medical Group, Spire Healthcare, BMI Hospitals and The Hospital Group, we can confirm that the average rupture rates reported for PIP implants is within the industry standard of 1%-2%.”
The IHAS had submitted its evidence to the working group convened by health secretary Andrew Lansley and chaired by NHS medical director Sir Bruce Keogh to investigate the safety of the breast implants made by Poly Implant Prosthese (PIP), a French company in the south of France that was shut down in 2010. it has also given the data to the UK regulator, the Medicines and Healthcare Products Regulatory Authority, “to ensure they have proper data with which to review the situation, rather than relying on the small sample of just 100 patients provided by Transform, which has been taken out of context,” said Taber.
“Our findings have been backed up by reports from nine other countries that have used PIP implants. we strongly urge the investigation team to conduct a thorough evidence-based audit before making any decisions on next steps.”
The claims from the cosmetic surgery clinics come as the French government ordered its own inquiry into how PIP managed to get around the regulators and supply substandard implants, filled with industrial-grade silicone rather than medical-grade, to somewhere between 300,000 and 400,000 women in 65 countries.
Laboratory examination of the implants commissioned by the radio station RTL is said to have revealed they also contained other industrial chemicals. André Picot, the toxicologist who carried out the research, is quoted as saying that offering such products for insertion in the human body was “near criminal”.
“All the elements now suggest that the gel [used in PIP's implants] was truly contaminated,” French health minister Xavier Bertrand told France 2 television.
“How was this not detected by checks?” he asked. “I want to know everything… I have asked for investigations at the Directorate General of Health and (health safety agency) to know what happened, how these checks were done.”
There are only two suppliers of medical-grade silicone worldwide and it is expensive. PIP was making very cheap implants and selling in bulk. one of the company’s suppliers has confirmed publicly that it sold silicone intended only for industrial uses to PIP.
“All the specifications of the product ordered from us correspond to industrial material,” Pierre Gaches, head of the Toulouse-based company Gaches Chimie, told French journalists. He added that his company supplied PIP with industrial-grade silicone since the early 2000s but that PIP had “never given us any information on how it planned to use” the material.
Chantal Jouanno, a member of France’s Sénat, the upper house of parliament, and a former sports minister, called for a parliamentary commission to be set up as soon as possible to look into the scandal. The PIP implants carried the CE-mark of quality assurance, which is dependent in the UK on regular visits to the plant and checks on the materials by MHRA inspectors.
That raises questions about the rigour of the quality assurance processes in France.
The French government has advised the estimated 30,000 women in France with PIP implants to have them removed but insisted this was a non-urgent “preventative” measure. British plastic surgeons have also called for the implants to be removed, saying that women will suffer discomfort if they rupture and great anxiety whether they do or not. However, if the IHAS figures showing a low rupture rate are confirmed, the expert group is unlikely to recommend routine removal, because there are risks to any surgery.
The Department of Health confirmed that the health secretary met Sir Bruce Keogh, the chief medical officer, Sally Davies, and the MHRA on Tuesdayto discuss the latest developments. it also said: “The expert group will meet tomorrow to discuss the preliminary findings on PIP breast implants.”