'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

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It is still impossible to tell women who received the implants, which were withdrawn last year after they were found to contain industrial grade silicone, what risks they run with any degree of certainty, the MPs say.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.

Voices
On the last day of campaigning before the polling booths open, the SNP leader has written to voters in a final attempt to convince them to vote for independence
voicesIs a huge gamble on oil keeping the First Minister up at night?
Sport
A 'Sir Alex Feguson' tattoo
football

Arts and Entertainment
Liam Neeson said he wouldn't
tv

Liam Neeson's Downton dreams

Voices
voicesApple continually kill off smaller app developers, and that's no good for anyone
PROMOTED VIDEO
Life and Style
ebooksA superb mix of recipes serving up the freshest of local produce in a delicious range of styles
Life and Style
ebooksFrom the lifespan of a slug to the distance to the Sun: answers to 500 questions from readers
Arts and Entertainment
Ben Whishaw is replacing Colin Firth as the voice of Paddington Bear
tv

Thriller is set in the secret world of British espionage

Life and Style
life

News
ScienceGallery: Otherwise known as 'the best damn photos of space you'll see till 2015'
Travel
travelWhy Japan's love hotels are thriving through an economic downturn
Life and Style
fashion

Bomber jacket worn by Mary Berry sells out within an hour

Life and Style
Alexander McQueen A/W 2014
fashionPolitics aside, tartan is on-trend again this season
Arts and Entertainment
Rapper Jay Z performs on the Pyramid Stage at Glastonbury in 2008
musicSinger sued over use of the single-syllable sample in 'Run This Town'
Sport
Joel jumps over the board...and into a giant hole
footballFrom joy to despair in a matter of seconds
News
i100
Arts and Entertainment
Pointless host Alexander Armstrong will voice Danger Mouse on CBBC
tv

Much-loved cartoon character returns - without Sir David Jason

Arts and Entertainment
Meera Syal was a member of the team that created Goodness Gracious Me
tv

Actress to appear in second series of the hugely popular crime drama

Latest stories from i100
Have you tried new the Independent Digital Edition apps?

ES Rentals

    Independent Dating
    and  

    By clicking 'Search' you
    are agreeing to our
    Terms of Use.

    iJobs Job Widget
    iJobs General

    Volunteer your expertise as Trustee for The Society of Experimental Biology

    Unpaid Voluntary Position : Reach Volunteering: Promising volunteer Trustee op...

    Email Designer

    £30000 - £35000 Per Annum: Clearwater People Solutions Ltd: Our client is curr...

    Psychology Teacher

    £110 - £130 per hour: Randstad Education Reading: Psychology Teacher needed fo...

    Food Technology Teacher

    £85 - £120 per day: Randstad Education Cheshire: Randstad Education are curren...

    Day In a Page

    Mystery of the Ground Zero wedding photo

    A shot in the dark

    Mystery of the wedding photo from Ground Zero
    His life, the universe and everything

    His life, the universe and everything

    New biography sheds light on comic genius of Douglas Adams
    Save us from small screen superheroes

    Save us from small screen superheroes

    Shows like Agents of S.H.I.E.L.D are little more than marketing tools
    Reach for the skies

    Reach for the skies

    From pools to football pitches, rooftop living is looking up
    These are the 12 best hotel spas in the UK

    12 best hotel spas in the UK

    Some hotels go all out on facilities; others stand out for the sheer quality of treatments
    These Iranian-controlled Shia militias used to specialise in killing American soldiers. Now they are fighting Isis, backed up by US airstrikes

    Widespread fear of Isis is producing strange bedfellows

    Iranian-controlled Shia militias that used to kill American soldiers are now fighting Isis, helped by US airstrikes
    Topshop goes part Athena poster, part last spring Prada

    Topshop goes part Athena poster, part last spring Prada

    Shoppers don't come to Topshop for the unique
    How to make a Lego masterpiece

    How to make a Lego masterpiece

    Toy breaks out of the nursery and heads for the gallery
    Meet the ‘Endies’ – city dwellers who are too poor to have fun

    Meet the ‘Endies’ – city dwellers who are too poor to have fun

    Urbanites are cursed with an acronym pointing to Employed but No Disposable Income or Savings
    Paisley’s decision to make peace with IRA enemies might remind the Arabs of Sadat

    Ian Paisley’s decision to make peace with his IRA enemies

    His Save Ulster from Sodomy campaign would surely have been supported by many a Sunni imam
    'She was a singer, a superstar, an addict, but to me, her mother, she is simply Amy'

    'She was a singer, a superstar, an addict, but to me, her mother, she is simply Amy'

    Exclusive extract from Janis Winehouse's poignant new memoir
    Is this the role to win Cumberbatch an Oscar?

    Is this the role to win Cumberbatch an Oscar?

    The Imitation Game, film review
    England and Roy Hodgson take a joint step towards redemption in Basel

    England and Hodgson take a joint step towards redemption

    Welbeck double puts England on the road to Euro 2016
    Relatives fight over Vivian Maier’s rare photos

    Relatives fight over Vivian Maier’s rare photos

    Pictures removed from public view as courts decide ownership
    ‘Fashion has to be fun. It’s a big business, not a cure for cancer’

    ‘Fashion has to be fun. It’s a big business, not a cure for cancer’

    Donatella Versace at New York Fashion Week