07/18/2012 (press release: OnlinePR) // Imogen Fry
Leading cosmetic surgery provider The Harley Medical Group has submitted written evidence to the publications and records section of the UK Parliament website – parliament.uk – in response to the Poly Implant Prosthèse (PIP) breast implants crisis.
The report, published yesterday (12 July 2012) is submitted under the parliamentary act HC163 Regulation of Medical Implants, along with evidence submitted by the Royal College of Surgeons.
In the written evidence, The Harley Medical Group stated that ‘PIP patients have been totally let down by the European regulatory system, of which the various local health agencies are part, such as the MHRA, the Irish Medicines Board and the French AFSSAPS’ and that ‘all the users of PIP implants, whether they be individual surgeons, national health services or private providers such as our group have been equally let down’.
In response to the crisis, which has affected approximately 14,000 of its breast implant patients, The Harley Medical Group has recommended the following, based on their experience with breast prostheses only:
• Testing should take place before commercialisation, not after
• Visits to manufacturers as part of testing after commercialisation should be unannounced and ‘take place several times a year’
• In addition to manufacturer visits, there must also ‘be visits to the distributors of the devices in each country’
• Implementation of a breast implant register, to be managed by the Medical and Healthcare Regulatory Agency (MHRA)
• ‘A compulsory reporting mechanism to the MHRA whenever there is a post-operative complication with a patient fitted with the implants’
• Measures put in place to ensure regulatory authorities can be made properly accountable for their failures
• Insurance to be compulsory for regulatory authorities, which will allow such bodies to step in financially in circumstances such as the PIP crisis.
• Clear, accurate and transparent communication from the regulatory authorities – for the benefit of manufacturers, distributors, clinics, surgeons, and the public.
NOTES TO EDITORS:
The full written evidence can be found here: http://www.publications.parliament.uk/pa/cm201213/cmselect/cmsctech/writev/163/m16.htm
Please note that this document is subject to Parliamentary Copyright, as detailed here: http://www.nationalarchives.gov.uk/information-management/our-services/parliamentary-copyright.htm
About The Harley Medical Group:
The Harley Medical Group is the UK and Ireland’s leading cosmetic surgery provider, performing more procedures and with more clinics than any other cosmetic surgery group. It has been established since 1983 and is one of the most highly regarded Cosmetic Surgery Groups operating in the UK. It has treated over 500,000 patients to date.
The Harley Medical Group works tirelessly to maintain the highest standards in the industry for the benefits all cosmetic surgery and non-surgical patients. We are currently at the forefront of the campaign to ensure that the Government continues to regulate the use of certain laser types used in cosmetic surgery and non-surgical treatments such as permanent hair removal, so that patients are protected from rogue practitioners.
In 2004, The Harley Medical Group’s Chairman Mel Braham, at the request of the Department of Health became a member of the department’s Steering Committee, set up to oversee the introduction of new regulations covering the entire Cosmetic Surgery sector. All of The Harley Medical Group’s clinics are registered with the Care Quality Commission. There are now 31 clinics in the UK and Ireland: London (Harley Street, Wimbledon, The City, Chiswick, Finchley & Watford), Marlow, Birmingham, Leeds, Brighton, Bristol, Manchester, Newcastle, Chester, Nottingham, Southampton, Cardiff, Chelmsford, Dublin, Northampton, Cambridge, Maidstone, Belfast, Reading, Sheffield, Liverpool, Bromley, Glasgow, Cheltenham, Leicester and Guildford.
Imogen Fry at Rain Communications Ltd
Telephone: + (0)20 7828 0118 / Email: [email protected]
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