'Inadequate and slow' regulator criticised over faulty breast implant scandal
MHRA failed to act promptly as thousands of women were left fearing for their safety, say MPs
Jeremy Laurance is a writer on health issues. He is former health editor of The Independent and the i and has covered the specialism for more than 20 years. He thinks the harm medicine does is under-appreciated, the harm it prevents over-rated, and that cycling works better than most drugs. He was named Specialist Journalist of the Year in the 2011 British Press Awards.
Wednesday 28 March 2012
The medicines regulator failed to exercise proper vigilance over cosmetic surgery in the PIP breast implant scandal which has left thousands of women fearing for their safety, a parliamentary committee will say today.
The Medicines and Healthcare Products Regulatory Agency (MHRA) was slow to respond to the unfolding scandal when it broke in December, made "inadequate" attempts to communicate with affected women and failed to gather "all possible evidence" on which to make a judgement about the safety of the implants, the Commons Health Select Committee says in a report.
It is still impossible to tell women who received the implants, which were withdrawn last year after they were found to contain industrial grade silicone, what risks they run with any degree of certainty, the MPs say.
An estimated 47,000 women in Britain received the implants, made by French company Poly Implant Prothèse, which were much cheaper than rival products and chiefly used by private clinics.
That alone should have triggered greater vigilance, the MPs say. After a high rupture rate was reported in France, experts convened by the Department of Health said there was no need for women to seek routine removal but they could seek a medical review and have implants removed if they were not reassured.
Stephen Dorrell, chairman of the Health Committee, said it was "broadly supportive" of the Government response but the events raised wider concerns about the regulation of medical devices.
There was insufficient evidence to judge the safety of the implants or even to allow doctors to know whether their patients were affected. "That is clearly unsatisfactory," Mr Dorrell said.
The MHRA was unable to confirm that no implants were used after it issued an alert in March 2010, because the private sector is not bound to respond to alerts.
"The obligations on care providers and the MHRA need to be urgently reviewed," Mr Dorrell said.
The risks posed by the implants may be worse than first thought as further evidence has emerged about the risk of inflammation associated with them.
Pierre Guillot, managing director of the Harley Medical Group, which placed the implants in 14,000 women, wrote to Sir Bruce Keogh, the NHS medical director and leader of the expert group, on 24 February noting that his surgeons had "noticed phenomena that they had never noticed with other implants" which had ruptured, including the presence of pus, redness and "lumpy granular tissue" in up to one in four cases. Even where the implants were intact, one in four showed signs of leakage.
The committee said the evidence should be examined "carefully and urgently" and early removal of the implants recommended if significant complications are found.
As Voltaire once said, “Ice cream is exquisite. What a pity it isn’t illegal”
Life & Style blogs
Movie pirate given almost 3 years in prison for filming Fast & Furious 6 in back of cinema
What is ALS and the Ice Bucket Challenge?
Mother fed her daughter tapeworms to make her skinny for pageant
Doctors tell Treasury of their anger at rejection of pay reviews
Tickets for Victoria’s Secret Fashion Show in London are not on ‘sale’
- 1 'Alien thigh bone' on Mars: Excitement from alien hunters at 'evidence' of extraterrestrial life
- 2 Mother fed her daughter tapeworms to make her skinny for pageant
- 3 Crystal Palace next manager latest: Palace consider Ally McCoist - EXCLUSIVE
- 4 Richard Dawkins on babies with Down Syndrome: 'Abort it and try again – it would be immoral to bring it into the world'
- 5 ALS ice bucket challenge co-founder Corey Griffin drowns, aged 27
Negotiable: Harrington Starr: Market Administrator (1st line Support, Trade Fl...
£35000 per annum: Harrington Starr: Service Desk Analyst (Windows, Active Dire...
Negotiable: Harrington Starr: Data Support Analyst (Linux, Solaris, Windows Se...
Negotiable: Harrington Starr: Helpdesk Support Engineer (Windows, MS Office, E...