Implants database talks already under way

In a letter to The Times newspaper, RCS President Professor Normal Williams criticises the current “lax” regulations surrounding surgical implants, in the wake of global concern over breast implants made by French company PiP.

Health Secretary Andrew Lansley has also warned that some private clinics have provided poor-quality data to a review into the risks of rupture posed by breast implants.

But a draft proposal for the mooted national database has already been sent to Medicines and Healthcare products Regulatory Agency (MHRA) by the Independent Healthcare Advisory Service (IHAS), Channel 4 News Health and Social Care Correspondent Victoria Macdonald has learned.

New surgical implant registry

The call by the Royal College of Surgeons for a mandatory database for all surgical implants to be established has already been partly pre-empted by the industry itself, writes Victoria Macdonald.

The Independent Healthcare Advisory Services, which represents the major cosmetic surgery chains, has for a year been in talks with the British Association of Aesthetic Plastic Surgeons about how such a register would work for breast implants.

Indeed, Channel 4 News has learned that just a few weeks before Christmas the IHAS had written to the Medicines and Healthcare Regulatory Agency (MHRA) with a draft proposal.

The idea of the register would be based on the National Joint Registry, established in 2002, and which is mandatory.

This records all patients undergoing joint replacement such as hips or knees and allows easy recall if there is a problem. A levy of about £20 is charged for each joint.

Sally Taber, of the IHAS, said the breast registry would include what type of implant was used, whether there were any complications in the surgery and whether, for instance, the patient had had previous implants.

There had previously been a breast implant registry but this was scrapped, mainly because of the reluctance of the patients to have their details recorded. Ms Taber said that times had now changed with patients much more aware of the value of storing data. “If there had been a register when this happened with the PiP implants it would have been much easier to contact the patients personally to explain the situation.”

For the registry to work, however, it would have to be mandatory which is more difficult with a process that is largely cosmetic and paid for by the patient.

Again, one proposal would be that they would be named and shamed by the Care Quality Commission, which is now required to inspect all NHS and independent clinics.

In his letter to the newspaper, Prof Williams expressed deep concerns about surgical implant regulation.

“Whereas there are strict criteria that must be met before a new drug can be administered to a patient in the UK, the regulation around surgical implants is far more lax – putting patients at risk,” he wrote.

“Provided a device gains a CE mark it can be implanted with relative impunity. There is no requirement on the company that markets the product, or the surgeon who implants it, to keep an appropriate audit trail relating to complications or longevity, and there is no infrastructure that allows the appropriate piloting, training and diffusion of the surgical technique that utilises a new implant.”

Mr Lansley earlier offered to dispatch data experts to private clinics to help gather statistics for a government-commissioned panel investigating the risks posed by the PiP implants.

But he reiterated his position that there is currently no safety concern which would justify the routine removal of the implants, contrary to advice in France.

“One of the reasons why I established the expert review was because it was clear from one of the private providers that we were getting inconsistent data,” he said.

“I wanted to make sure that we did get all of the data and we got as good data as we possibly could.

“Some of the private providers, as of yesterday, had not provided any data at all, many had, some had provided what on the face of it looks quite good data, others what appeared to be very poor quality.”