Vale Healthcare Update | PIP breast implants

There has been significant press coverage and patient concern regarding the PIP breast implants. Vale Healthcare can confirm that the PIP breast implants have not been used in any surgery performed at the Vale Hospital (or any other Vale Healthcare site).

Nuffield Health (who own and operate Vale Healthcare) have released a recent statement on their website, confirming that should any patient require clinical investigation or further surgical treatment, including the removal of the PIP implants due to clinical need, they will meet the costs incurred. This applies to Nuffield hospitals where the PIP implants have been used.

Please see the full statement here.

7th February 2012

In response to the committee hearing on Tuesday, Newsnight’s Jeremy Paxman chaired a debate on PIP breast implants; a panel of women representing the 40,000 Brits who were given PIP implants were invited to pose their questions to Public Health minister, Anne Milton. Dr Andy Jones, Group Medical Director of Nuffield Health, was interviewed for the programme discussing the role of the regulator. You can watch it here.

9th January 2012

Health Secretary Andrew Lansley announced that the NHS will offer consultations to all women with breast implants from the now defunct Poly Implant Prothese firm and remove the implants if they ask. Mr Lansley stressed that private clinics should pay for a similar "model of care" but said the NHS would cover the costs where clinics no longer existed or were refusing to co-operate. It is estimated the move will cost millions of pounds in consultations, imaging checks and operations. Under pressure to take more decisive action, Mr Lansley has also called for a review of the cosmetic surgery industry as a whole.

Nuffield Health welcomed the recommendations made by the Mr Lansley and will work closely with the Government and contribute to the reviews of the cosmetic surgery industry announced today.

We said: “We agree that it is important to learn the lessons in relation to PIP implants. As the first provider to offer the free removal and replacement for those patients with PIP implants, Nuffield Health is concerned that some other providers are not following the direction set by the Secretary of State. As industry leaders we feel it is essential that patients continue to have confidence in cosmetic services and today we have issued a 10 point plan which we urge the rest of the sector to support.”

Please see below for full details of the plan.

Nuffield Health's 10 point plan to ensure the safety of cosmetic patients

The issues and concerns raised over PIP implants in the last month provide an opportune moment to reflect on the cosmetic industry; the standards, regulations and activities, and have prompted Nuffield Health to suggest a standard of best practice that all in the industry could adopt in order to ensure the safety and best interests of patients.

Nuffield Health calls for…

1. The guidance for all medical devices to be re-examined to ensure patients can be tracked quickly and effectively if concerns are raised around any implants they received.

2. Standardised data collection methods to be used to improve outcome data.

3. The government to reintroduce a National Implant Registry for all breast and other cosmetic implant medical devices (as with the hip, knee and ankle registries).

4. A review to take place of all other voluntary registries (such as the bariatric surgery registry) and consider extending to other implants (such as pacemakers and cataract lenses).

5. The introduction of standards for patient information and informed consent with ‘cooling off’ period for all cosmetic surgery.

6. International collaboration to allow monitoring of the issues and complications which can arise from breast implant surgery.

7. A review of the actions and guidance provided by the MHRA on PIP implants and of the CE marking scheme for medical devices.

8. The MHRA to make it clearer to doctors on how to report issues with medical devices.

9. The implementation of wider safeguards for patients of all cosmetic treatments, injectables, fillers and medical lasers. A ban on direct consumer cosmetic advertising (as exists for medicines). Fillers to be reclassified as prescription-only medicines. Deregulation of lasers to be reversed.

10. The consideration of an industry “bond” scheme (along the terms of ABTA / ATOL in the travel industry) where all cosmetic providers are required to provide a guarantee scheme to protect patients. This must include the provision of hospital facilities and follow-up to manage complications, longer-term follow-up and specialist care when required by patients.