Statement from Sally Taber, Director of the Independent Healthcare Advisory Services (IHAS) in response to the Ministerial Statement by the Right Honourable Andrew Lansley MP, Secretary of State for Health

11 January 2012

IHAS, which represents the majority of healthcare providers affected by the MHRA failure to detect the faulty PIP implants, welcomed much of the Secretary of State’s announcement.

Whilst the intention of the Health Secretary was to offer guidance, patients are feeling more confused and anxious now than ever before. With current Government position remaining unclear, patients want to know the timeline for the further investigations into PIP implants by the MHRA.

There is need for clarity on how patients can access scans and ensuring that all GPs are authorised to order scans.  

Despite the private sector requesting a meeting with the Department of Health since Friday 6^th January, the public and private sector have yet to meet and agree a deliverable solution.  Our members have stepped forward to give all the assistance they can to the Expert Panel.  We are yet to see comprehensive data from the NHS private patient units.

Members of IHAS are as much a victim of this fraud as the NHS and the patients.  We all trusted the standards regulator, the MHRA, and the Department of Health.

If there is any moral or ethical obligation outstanding it lies with the Government’s regulatory agency, the MHRA. But the overriding issue here is that it is in everyone’s interest to work together to ensure that patients are treated with compassion.

The IHAS welcomes the intention for CQC to carry out unannounced inspections of independent providers. All our members comply with the CQC guidance framework and are registered by the CQC.

Read the complete speech made by the Secretary of State and the accompanying questions and answers on www.publications.parliament.uk

Notice to Editors

IHAS is a trade body of the independent acute healthcare sector and counts among its Members all the largest independent healthcare providers and many of the medium sized ones. Its remit is to facilitate better regulation and improved quality standards among its members, many of whom are leaders in their field of speciality.  IHAS has, at government instance, established The IHAS Register of Injectable Cosmetic Providers, an industry standard-setting Register of providers of injectable cosmetics including Botox ® and dermal fillers called Treatments you can Trust. It published, at the request of the GMC, Good Medical Practice in Cosmetic Surgery, which sets standards for organisations

Contact:

Sally Taber
T: 020 7379 8598
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The Independent Healthcare Advisory Services responds to Government advice on PIP implants

6 January 2012

Sally Taber, Director of The Independent Healthcare Advisory Services, comments:

"The IHAS applauds the Department of Health’s decision not to cause women unnecessary worry and trauma by advising immediate explantation of PIP implants. We welcome the clarification of advice today but we now want the Government to face up to their responsibility as regulators of PIP implants. All public and private sector surgeons used these implants, which were not the cheapest on the market, in good faith with the knowledge that they had been approved by the Department of Health agency, the MHRA.

“Our current advice to patients is to visit the website of their clinic provider and follow the advice detailed there. Patients can be assured that all of our member organisations are prioritising patient care above all else and all have all undertaken to provide free consultations for women who would like to consult a surgeon.”

The Department of Health says that their main concern is the safety of and compassion for women who have had PIP implants and are seeking to offer them as much advice and evidence as is available. The government’s expert review has not been able to establish if the rupture rate is higher for PIP implants than for others. It has also confirmed that there is no evidence of cancer risk from the materials used. Therefore their advice remains the same: that there is not sufficient evidence to recommend routine removal and women who are concerned should speak to their GP or surgeon. “Well before this issue emerged we were encouraging the MHRA development of a national, compulsory, device-based Register, following the dissolution of the breast register in 2006 and we continue to champion this course of action."

More info:

To arrange an interview with Sally Taber contact Rain Communications on 020 7828 0118.

Department of Health announcements on PIP implants

The following announcements are copied from the Department of Health for the information of visitors to this site:

PIP Breast Implants: letters to professionals from David Nicholson and Chief Medical Officer

6 January 2012

The Chief Executive of the NHS Sir David Nicholson, and Chief Medical Officer Dame Sally Davies have written to health professionals with updates on PIP Breast Implants.

• Read the letter from David Nicholson [PDF 49KB]
• Read the letter from the Chief Medical Officer [PDF 53KB]

PIP Breast Implants: Interim Report of the Expert Group

6 January 2012

This is the interim report of the expert group brought together in relation to breast implants from the French company Poly Implant Prostheses (PIP).

The overriding concern of the group is the safety and compassionate treatment of women with PIP breast implants.

This report:

• reviews the available data on the health risks from PIP implants
• concludes that there is no clear evidence at present that patients with a PIP implant are at greater risk of harm than those with other implants, and we therefore agree with the MHRA advice that there is no specific safety concern identified which requires a recommendation of routine removal of PIP implants
• recognises the anxiety of many women who received PIP implants in good faith on the assumption that they were manufactured in accordance with EC standards
• commends and endorses the decision of DH ministers that, where women have received a PIP implant as part of NHS treatment, they will be contacted to inform them that they have a PIP implant and to provide relevant information and advice; and will be offered further procedures subject to clinical need and taking full account of the wishes and concerns of the patient
• expects private sector providers to take similar action
• the available evidence is subject to considerable uncertainty and therefore we recommend the collection of additional information which will enable the group reach a more informed view

• Read the PIP Breast Implants interim report [PDF 159KB]

The Independent Healthcare Advisory Services urges the Government to conduct a thorough evidence based audit as it welcomes the review on PIP implants

3 January 2012

Sally Taber, Director of The Independent Healthcare Advisory Services, comments:

"The IHAS supports the Government's creation of an expert group to examine evidence on the occurrence of ruptures of PIP implants. It is vital for patients' physical and mental wellbeing that policy is based upon clear and reliable evidence. 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 per cent. The IHAS has submitted this evidence to Sir Bruce Keogh and the MHRA 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.

“Our findings have been backed up by reports from nine other countries that have used PIP implants. In advance of tomorrow’s meeting chaired by Sir Bruce Keogh to discuss the issue, we strongly urge the investigation team to conduct a thorough evidence based audit before making any decisions on next steps.”

The IHAS calls for breast registry

“We have been encouraging the MHRA to bring back the breast registry, which was dissolved in the early 1990s. Right now it is essential that we have proper ethical data management with regards to PIP implants. These implants were approved for use by the regulatory authorities. All industry groups, including the NHS, surgeons and the major private hospital groups, acted responsibly and in good faith by using these approved devices."