The biggest scandal to have hit the plastic surgery profession took a new turn with the publication on 14 May of health minister Lord Howe’s review of the PiP breast implants affair. Lord Howe found that, although the regulator acted appropriately and followed scientific and clinical advice, there is room for improvement and serious lessons must be learned.

Lord Howe was tasked with looking into whether the Medicines and Healthcare products Regulatory Agency (MHRA) and the Department of Health acted properly both before and after information about the implants came to light. He made a number of recommendations for improvements to the operation of the MHRA, including that it should identify ways of gathering better evidence on the safety of devices, broaden its approach to analysing reported problems with higher risk medical devices and find better ways of communicating with the public.

The review also calls for the operation of the European regulatory system to be improved and for health professionals and providers to be better at reporting problems when they occur.

Two of the leading professional bodies in the field broadly welcomed the report but repeated calls for a mandatory register of implants.

The president-elect of the British Association of Aesthetic Plastic Surgeons (BAAPS), Rajiv Grover, said in a statement: “We welcome the findings of the Government’s review into the PiP scandal, and agree in particular that there should be a better system of reporting for medical devices, with data gathered from a wider set of sources that should be routinely reviewed. For the last few years, BAAPS has been championing the reinstatement of a compulsory implant register that would monitor not just breast but all types of implant put into the body. The register is part of our regulation proposals put forward earlier this year and would immediately address all the recommendations put forward in this report, as would a mandatory safety audit based on the model that BAAPS requires of all its members.”

Tim Goodacre, chairman of the professional standards committee of the British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS), said: “BAPRAS welcomes the findings of Lord Howe’s review and we 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.
“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.”
Not everyone was heartened or reassured by Lord Howe’s findings, however. A medical negligence specialist who represents over 100 women affected by the scare was scathing about the peer’s statement that: “The MHRA had to balance the need to provide full information against the risk of causing undue concern to women when they did not have clear evidence of potential harm.”

Stephanie Fallon of Merseyside-based Lindsays Solicitors, said: “It is this finding that has caused consternation among those women who have been deprived of an opportunity to make a decision as to whether or not they wished to retain implants containing industrial grade silicone and a high rupture rate in their bodies.

“It is not an executive decision to be made by a regulatory body but a decision to be taken by the women themselves, having regard to all of the relevant information.”