BAPRAS response to Select Committee Report on PIP implant policy

29th March 2012

 

The Select Committee have released  their findings from the inquiry into the Department of Health and associated bodies’ handling of the current PIP implant crisis. The broad thrust of the Report is fair and raises important points which the Government, industry, and professional bodies should heed and act upon. The Committee heard evidence over the course of only one day and from just 4 highly qualified experts, including Sir Bruce Keogh, Sir Kent Woods (CEO of the MHRA), an ethicist Dr Slowther, and Simon Withey as the sole plastic surgeon. The limited amount of time devoted to gathering evidence is reflected in the report, which is not  comprehensive, and urges several courses of action which might prove to be impractical or costly. 

Comments on specific recommendations


Evidence on risks of implants
BAPRAS supports the call for continued highest quality data collection to determine the safest course of management for women with PIP implants. However, this process must be managed effectively and the results acted upon swiftly and with good judgement. We have urged members to complete reports for patients they explant as part of the data collection exercise. However if the  reports of abnormal inflammatory reactions to either ruptured implants or intact devices with excessive silicone 'bleed' are substantiated, we would expect an urgent response from Sir Bruce's group recommending appropriate action which might well involve case finding to recommend removal. This would require a mechanism for patient tracing as well as better data capture and reporting. To date, there appears to be no means of detecting which batches of implants are generating such tissue responses, or which are more likely to rupture. 

The 'NHS Offer'
BAPRAS agrees that there needs to be greater clarity on private clinics’ legal obligations to their clients. In commerce, the purchaser of faulty goods has a right of return to the supplier, who then accepts the responsibility for further claim against the manufacturer. There is no reason why this should not be the case here.

The Committee highlights the difficulties faced by patients whose private provider either no longer exists or refuses to acknowledge their responsibility under the DoH’s 'moral imperative '. Those patients are entitled to removal of implants under the NHS, but not replacement unless ‘clinically indicated’. This raises a number of complex issues. BAPRAS’ view is that the recommended process, which avoids some additional GA procedures for women who choose NHS explantation alone and subsequent private replacement, would be very difficult to develop and unachievable, for the following reasons:

•  The NHS cannot distance itself from all responsibility for future care, as this runs counter to NHS guiding principles and all established statutory responsibility from surgeons as well as hospitals. Legal precedents would almost certainly upturn such a policy
•  Many patients seeking PIP removal and replacement require other procedures (most commonly mastopexy) which renders the delineation of NHS/private care more problematic
•  Modifying the NHS offer in this way would lead to an influx of patients, whose original private provider would recognise the potential to shift their financial burden onto the patient (sharing the procedure cost with the NHS). The NHS would struggle under this additional load, which would require additional bed space, theatre time, patient support and staff with commensurate costs for out of hours provision.

BAPRAS will continue to work with the DoH to develop the most caring process possible for patients, whilst recognising the demands on NHS plastic surgical units and limited skilled surgical time.

CE Mark
BAPRAS has repeatedly called for stronger regulation of all devices, particularly following the Replicon-Meme & Trilucent matter. We would like the CE mark to at least match standards imposed by the US FDA, and to be of the highest obtainable internationally.

Registry of Implants
BAPRAS has campaigned for a device registry for several years, and laments the loss of the original MHRA registry. We recognise the ethical difficulty presented by mandatory registration for implanted devices, but believe the benefits outweigh the disadvantages. We also recommend that technological innovations to facilitate device tracking and identification whilst respecting privacy requirements, should be adopted by manufacturers.

Responsibilities of professionals and their organisations
BAPRAS has the concerns of the patient at the core of its organisation. We therefore maintain rigorous educational standards and advise on many matters including the use of medical devices and adverse incident detection and reporting. We will continue to support members’ education and professional development and to extend this support to non-members.

Advertising for cosmetic surgery
BAPRAS considers some current advertising practices as abhorrent to those seeking to provide a caring and sensitive service to individuals with concerns over body image matters. However, we believe that good quality information should be available to enable the public to make informed decisions. In that context, any advertising or public material should be well regulated. We worked with BAAPS in 2006 to develop acceptable guidance advertising for individual surgeons, which was presented to the GMC. We would urge the government to adopt a similar requirement for clinics, whilst not encouraging an outright ban on all cosmetic surgery advertising.

Conclusion
BAPRAS welcomes the intervention of the Select Committee on this matter. We will continue to work with groups set up to develop more robust and responsive systems to ensure that such problems are not repeated in the future.

Tim Goodacre
Chair, BAPRAS Professional Standards Committee


 

 

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