Health Minister Lord Howe’s review into PiP breast implants published on 14th May 2012 has found that there is room for improvement and serious lessons must be learned, although it considers the MHRA to have acted appropriately and to have followed scientific and clinical advice when it became aware of problems with PiP implants.
“There is no evidence in relation to PIP implants that the MHRA or the wider Department of Health significantly failed to do their job. But they must learn lessons to help provide a stronger assurance for patients and the public that the device regulatory system is working to safeguard their health.”
The review calls for improvements for the MHRA. It recommends that the MHRA should:
- identify ways of gathering better evidence on the safety of devices
- broaden its approach to analysing reported problems with higher risk medical devices
- find better ways of communicating with the public
The review also calls for operation of the European regulatory system to be improved and for health professionals and providers to improve their reporting of problems when they occur.
The report states:
There are however lessons to learn and areas where improvements can and should be made for the future. Adverse incident reporting is an inherently imperfect way of collecting data. It relies upon all those involved in delivering care – clinicians, cosmetic surgery providers, and manufacturers – playing their part in full and acknowledging the importance of adverse incident reporting in protecting patient safety. All those involved must redouble their efforts to improve reporting of incidents and ensure that information is shared with the MHRA. Even then, reporting will never reflect 100% of the experience with a device and this means other information must be generated and used.
The MHRA must be able to obtain evidence from a wider and more detailed set of sources, including robust outcomes data from clinicians. It needs to be at the forefront of using more sophisticated and rich sources of data to determine if there are problems with a device. It must have the ability to review routinely the sum total of the information about specific higher-risk devices, to ensure that the need for any further action is identified promptly.”
To read the review click on link: Lord Howe’s Report into PiP breast implants
Read Department of Health article: http://www.dh.gov.uk/health/2012/05/pip-revew/
Sir Bruce Keogh, NHS Medical Director, is undertaking a review of the wider system of regulation for cosmetic surgery. He will chair an independent expert group looking at whether a breast implant registry could be put in place in the UK to help monitor any problems that occur and make it easier to trace people affected if there is a problem in the future.
Read more news stories on Review of PiP Breast Implants:
TVT info Comment
Many women who have suffered problems from vaginal mesh implants have also called for a registry for implants used in pelvic surgery. They feel that the current voluntary reporting system for adverse events is inadequate and that a registry would be a more effective way of flagging up problems with mesh implants.
They would also like a review of the way devices are approved as they feel that there is no way of knowing whether a device is safe and whether it has undergone adequate testing before being put on the market.
What do you think? Please feel free to leave your comments….