Written evidence from Mr Nigel Mercer, Chair of Plastic Reconstructive and Aesthetic Expert Advisory Group (PRASEAG) of MHRA [BIP0124]

The History of PIP implants and their regulation by TUV Rhineland

TUV Rhineland was the notifying body for PIP and they gave PIP’s management notice of their inspections of the production facility. The owner of PIP, Mr Mas, responded by removing the inappropriate materials from site and replacing them with the CE marked materials, which were then inspected by TUV Rhineland.

In addition, one of the significant issues with ‘bad’ PIPs was that the ‘patches' on the back of the implants were also defective. The patch seals the implant and the defective patches led to the higher rupture rate of ‘bad’ PIPs and exposure of the non-medical grade silicones directly to the patient’s body. 

Not all PIPs had one or both of the defective filler and/or the defective patch and is why some PIPs produced in that era were not defective and some were.

The destruction of company PIP records and the lack of an implant register in the UK (lost due to the government removing funding) meant it was impossible both to locate patients and to know who had what type of implant in situ.

As a result, the issue for all PIP patients was, and remains, not knowing whether they had a ‘good’ or a ‘bad’ PIP is situ, even if they had their implant records.

As was said in evidence, an implant's life expectancy is 10-15 years and any PIPs still in situ will be at the end of their CE marked natural life expectancy.

However, the fact the implants have survived 15 years is an indicator they were made according to the CE mark. In that light, the suggestion that all PIPs should be scanned and be removed by the NHS, as was discussed with the Committee, effectively, means that 15 year old implants made by any manufacturer would have to be scanned and removed, whether or not they have been implanted in the NHS or private sector. The impact of that, if it is adopted, will be very significant for NHS breast services.  

The Chair asked those attending why we are in this situation in the United Kingdom and what the government can do to improve regulation?

We are in this situation because we remain hidebound by legacy, EU regulation surrounding all breast implants and dermal fillers.

What is required to improve patient safety

a. As with FDA approval, safety testing should be introduced for all dermal fillers and all implants before they are CA marked. ‘Equivalence’ should no longer be a short cut to certification in the United Kingdom.

b. Post market surveillance for any implant inserted into a patient should be for the patient’s lifespan and continue after removal of the implant. The patient is, in effect, the ‘experimental animal’ for any implant inserted.

c. Dermal fillers should be reclassified as ‘prescription only devices’.

d. The United Kingdom requires mandatory registration of all devices implanted with the BCIR (including dermal fillers).

e. In addition, reporting of all implant related complications to MHRA must be made mandatory.

f. There must be compulsory complications/revision insurance for any surgeon/provider/operator offering surgical packages both at home and overseas. This is NOT the same as indemnity insurance and is available in the UK>

g. ‘Phoenixing’ of financially viable cosmetic intervention businesses should be made illegal to ensure patients’ legal rights are maintained. Viable companies, currently, can liquidate, which removes protection of patients’ legal rights.  

h. Mandatory Certification of practitioners in both cosmetic medicine and surgery is required.

i. Progress is being made by the government on the certification of practitioners in cosmetic medicine.

j. However, regulation of surgeons performing cosmetic surgical procedures is completely lacking in the United Kingdom.

Cosmetic surgery in not only performed by Plastic Surgeons in the United

To improve patient safety, legislation should be introduced to enshrine the Board Certification scheme in statute to ensure only appropriately trained and experienced surgeons can perform cosmetic surgical procedures in the United Kingdom.   

The only proven pathway in the United Kingdom, approved by all four Royal Colleges of Surgery in the British Isles is the Inter-Collegiate Surgical Board scheme. The scheme allows those surgeons with the appropriate core and specialist training to be certificated in the procedures in which they specialise i.e., to ‘Board Certify’.

July 2025