BAPRAS responds in detail to the Lord Howe review

15th May 2012

 

Following the review of the situation surrounding PIP implants, led by Lord Howe, Tim Goodacre, Chairman of BAPRAS' Professional Standards Committee said:

“BAPRAS welcomes the findings of Lord Howe’s review and hope that this will lead to improvements in the regulatory system for medical devices. We urge members to vigilance and rapid reporting of adverse events, especially involving new products and devices and will encourage heightened awareness in both NHS and private sectors through every means at our disposal.

“We also welcome improved systems for the detection of trends, and the better responsiveness of the MHRA to early detection and improved communication with other Governmental, and European institutions.

“BAPRAS agrees entirely with the recommendation that 'routine incident reporting and review of outcome data by individual surgeons and providers should be the norm', which endorses our current programme to establish robust and rigorously used systems of data collection by our members (and indeed all plastic surgeons).

“We naturally also support fully the recommendation that a well designed breast implant registry be re-established, and believe that such a process could act as a model or template for other higher risk implanted devices.

“As an Association we would embrace the opportunity to continue or develop our representation on the Committee on Safety of Medicines (CSM) and value our continued strong engagement with Sir Bruce Keogh's group as it looks at clinical governance, audit, and reporting in cosmetic surgery.

“Finally, we wholeheartedly support the recommendation that 'all parties be treated as equal partners' in the vigilance that will be required in future to ensure that patients are protected from any future incidents similar to that presented by PIP.”

 

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