Written evidence from Nigel Mercer, Consultant Plastic Reconstructive and Aesthetic Surgeon [BIP0001]
Response by N Mercer, Consultant Plastic Surgeon, GMC 2626770
MB ChB ChM FRCS (Eng) FRCPCH FFFMLM LLM FRCS (Ed ad hominem).
… The Women and Equalities Select Committee is conducting a targeted call for evidence looking at broad concerns surrounding breast implants, cosmetic surgery and patient safety, including Poly Implant Prothèse (PIP) breast implants. We have selected a specific group of relevant stakeholders to provide written evidence, and we are pleased to invite you to contribute.
We are seeking insights and evidence on the following key areas:
Specific PIP related questions:
• What is the risk to individual women’s health and the wider health system, caused by PIP implants?
The enormous benefits of the use of breast implants for women and trans patients must not be forgotten in this discussion. The majority of women who undergo breast reconstruction for breast cancer in the United Kingdom have a breast implant/tissue expander inserted and are pleased with the result. The majority of women who undergo breast augmentation for cosmetic reasons are also satisfied with the procedure.
However, there are well known risks that all patients undergoing breast implantation must be aware of in their decision making process, including alternative methods of both reconstruction and augmentation of the breast, although in the latter those alternatives are very limited and carry additional risks, over and about conventional breast augmentation.
What was the cause of the scandal?
M. Mas illegally changed the filler material of his company’s PIP textured implants. This appears to have been done on an ad hoc basis by M. Mas, with some batches made according to the established CE mark and others made with a varying concoction of non-CE marked silicones, including siloxanes and non-medical grade, liquid silicone.
The ‘patch’, which holds the filler in place inside the implant, was also changed by M. Mas, which resulted in it being less effective at maintaining the integrity of the implant, increasing the rupture rate.
It is not known how many, or what proportion of implants were made illegally, sold and implanted because the records, I understand, were either not kept or were destroyed by M. Mas.
M. Mas dissolved his company when his crime became public, avoiding both legal recourse or the legal requirement for ongoing care of his company’s patients in the UK and overseas.
The competent body responsible for PIP CE marking (TUV Rhineland) was not aware of M. Mas’ illegal behaviour.
PIP implants made according to the CE mark appear to have behaved as any other CE marked breast implant of that time.
The illegally made implants had a greater risk of rupture resulting in leakage of the filler material. The materials then released into the implant cavity caused intense inflammation, with rapid increase in size of the affected breast, requiring urgent removal of the implant and its contents. The inflammatory reaction also involved the loco-regional lymph nodes, which became painful and swollen in affected patients.
Why was it difficult to contact affected patients?
When the issue became known to the profession, it was not possible to contact patients directly with PIP implants in situ.
The original, breast implant register (UKBIR), held at Salisbury NHS trust had been discretionary. It was opened in 1993 but closed in the mid 2000s due to removal of Government funding. It has, thus far, not been possible to access the database or migrate the data to the new Breast and Cosmetic Implant Register (BCIR), now held by the Outcome Registries Programme (ORP), currently hosted by NHSE.
A publication by Shakespeare, Bazire and Whitworth in 2005 indicated there were 80,000 patients with 140,000 implants recorded in the old implant database.1 The withdrawal of government funding for the database will have impacted on contacting patients with PIP implants in situ.
The information on the original Salisbury database should be migrated on to the new BCIR database. Over 80,000 women and trans patients deserve that to happen as soon as possible. The Government at the time exposed them to unnecessary risk by removing the funding for the original database.
The new Breast and Cosmetic Implant Register (BCIR) remains discretionary and was opened in 2016. It is now an opt out registry for patients and their consent is not required for registering implants and patients on the database. However, it is not mandatory. It is also essential that the Outcome Registries Programme (ORP), of which the BCIR is part, does not fail. The ORP remains under threat due to poor funding and the closure of NHSE, which houses the programme. Loss of the outcome registries, including BCIR, the trauma (TARN), national joint (NJR), national consultant information programme (NCIP) and ophthalmic lens registry would be a disaster for healthcare in the UK.
Take up of registrations on the BCIR has improved very significantly in recent years but is still not mandatory.
For example, the Sunderland ECHO reported in 2018, 8 years after the PIP implant scandal;
‘But NHS Digital, which manages the register, said that 39% of NHS providers and 24% of independent providers who offer breast implant surgery are yet to register patient details.’2
The BCIR Annual report for 2022 showed that 16,850 patients underwent 17,300 procedures at 336 NHS and private providers. Data collection continues to improve but it should be mandatory for surgeons and organisations/providers to collect the data.3
In addition, experience has shown women who seek cosmetic breast augmentation may not keep the implant details given to them at the time of the surgery or may simply have lost or forgotten the details.
What are the risks?
The risks of the standard elements of the PIP implants appear to be the same as for breast augmentation with any other CE marked breast implant, namely bleeding, infection, poor scars, changes in sensation, inability to breast feed, obscuring mammography, capsule formation, late seroma, BIA-ALCL and BIA-SCC, symptoms being described in common parlance as BII, ongoing need for revision and the complications thereof and the lifelong need for surveillance with the cost implications.
The risks of appropriately CE marked and manufactured PIP implants are the same as for any other CE marked implants, as discussed above.
The risks to human health posed by the concoction of fillers used by M. Mas are unknown in the medium to long term.
The accepted life span of a CE marked breast implant, especially one that is liquid filled, is in the region of 10 years.
Capsule formation is a natural response to any foreign object placed under the skin of an animal. The body is attempting to wall the object off. In the human, this can increase the stability of an implant but with breast implants leads to progressive hardening of the implant, ending with the implant becoming misshapen and painful (Baker Grade 3 and 4 encapsulation). The end result of this process can be calcium deposition in the shell making it rock hard and, potentially, to the formation of BIA-SCC. This is thought to occur as a result of the same mechanism as the formation of a squamous cell carcinoma in a chronic leg ulcer (Marjolin’s ulcer).
As with any implant, there is both wear, tear and degradation with age that lead to the shell weakening and an increased risk of rupture. Rupture of CE marked, medical grade, liquid silicone causes progressive hardening of the breast capsule around the implant.
The long term effects of the illegally used chemicals and constituents is unknown, unless there is prior toxicological evidence to refer to for those substances. The problem, however, is that the constituents of individual implants appear to remain unknown, even following removal and sampling of ‘bad’ PIPs.
The poor manufacture of the patch meant that the ‘bad’ PIPs appeared to manifest themselves relatively soon after implantation through premature rupturing.
Breast implants are not lifelong devices and are increasingly likely to require revision surgery after 10 years. We are now 15 years on from the PIP scandal, which is towards the end of the life span of a CE marked implant, especially one that was filled with liquid silicone or a less cohesive gel. With the known defects of the illegally made PIP implants it is, therefore, likely they would already have failed and those implants still in situ are more likely to have been made according to the CE mark.
With any CE marked breast implant, patients who undergo implantation for reconstructive reasons require ongoing NHS care and, potentially, revision surgery for life.
Patients who undergo breast augmentation for cosmetic reasons also require lifelong care, potentially including surgical revision, but at the patient’s expense.
The NHS will remove implants inserted for cosmetic indications but will not replace them or perform a reconstructive procedure. Patients may have been put off having PIP implants removed because there is a common belief that a breast lift (Mastopexy) is required but, in my experience, that is unnecessary. With implant removal and capsulectomy alone, the breast envelope settles back to a natural shape and this approach avoids the lollipop scar that a mastopexy inevitable leaves, replacing the natural colour change between the areolar and the breast skin with an obvious circular scar.
And how do the risks differ between PIP implants and other types of breast implants?
Please see above.
PIP implants made according to the CE mark expose women to the same risks as any other CE marked, textured implant.
Cases of BIA-ALCL have been reported with PIP implants and there does not appear to be a disproportionate risk compared with other textured implants according to MHRA data.4
• Is there evidence of women requesting that their PIP implants are removed and not being given access to that procedure?
I am not aware of women being refused removal of PIP implants. As stated, the NHS will remove breast implants inserted in the private sector but will not provide any additional treatment, such as a breast lift (mastopexy) or replacement breast implants. The common belief that a mastopexy is required after implant removal may have put many women off removal.
• How have Sweden and France interpreted the medical evidence and reports in relation to PIP implants, and come to a different conclusion and approach to the UK? And what difference has that made in practice, in terms of patient safety?
France and Sweden adopted much the same policy as the UK with respect to recommending removal of PIP breast implants. They offered follow up scans at 6 monthly intervals to assess rupture in those patients who elected to keep their implants in situ. Implant rupture is usually rapidly apparent and an indication for urgent removal. The inability to contact women and trans patients with PIP implants in situ meant that organised follow up was also not possible. The UK healthcare system had to rely on self-referral.
• What are the barriers to contacting and removing the implants of all 47,000 affected women?
Closure of the original Breast Implant Register based in Salisbury NHS Trust, as a result of removal of government funding, rendered it inaccessible. As a result, it has not been possible to contact and/or trace registered individuals who have a breast implant, including PIP implants, in situ. It has also not been possible to migrate the old database to the new BCIR database. Over 80,000 women and trans patients on the database have been exposed to unnecessary risk due to removal of government funding and failure to migrate the information to the new BCIR. This should be rectified urgently.
In addition, women may not be aware of what sort of implant they have in situ because they were not given or did not keep the implant details.
National media widely publicised the PIP scandal over a prolonged period of time and it would be reasonable to assume women with implants would have been aware of the issue and of the advice to seek a consultation with the NHS, their original surgeon or provider, or with several surgeons, such as myself, who were offering free consultations for women with PIPs in situ.
• What would be the effects of removing PIP implants from all 47,000 affected women, both in terms of cost to the state and the health of those affected?
After 15 years, it may be reasonable to assume those patients with PIP implants still in situ have implants that conformed to the CE mark. As such, there would be no additional benefit of removing implants at this stage in comparison with patients with other CE marked implants in situ.
Patients with CE marked implants, including ‘good’ PIPs, inserted for cosmetic reasons in the private sector have always had to pay for ongoing care, including further cosmetic surgical procedures on the breast.
Removal of CE marked implants is not recommended and so there is a cogent argument the same should apply to PIP implants currently in situ.
Removal of 47,000 implants would swamp NHS breast cancer services.
Wider issues:
• Are there other breast implant-related health concerns that patients and health practitioners should be aware of, for example, BIA-ALCL?
Please see above.
There does not seem to be an increased risk of BIA ALCL for PIP implants over and above other textured breast implants. The incidence of BIA SCC is not known accurately for any breast implants at this time.
I am not aware if any other cancers have been found in the last 15 year associated with the illegally made PIPs. A PubMed literature search (3 April 2025) has failed to yield any reports of patient being affected (see bibliography).5
• Are there any cosmetic procedures that are currently popular that are a cause for concern?
All cosmetic procedures are a cause for concern.
It is becoming clear patients seeking cosmetic surgery and medical treatments have a high incidence of Body Dysmorphic Disorder. A recent paper found 21% of those studied had elements of BDD6 and, as yet, there is no reliable screening tool that will highlight patients how may have a poor outcome from even clinically successful surgery.7
Cosmetic surgery and medicine are billion pound industries and are unregulated. Sir Bruce Keogh, Medical Director of the NHS, commented in 2014, that a consumer buying a toothbrush has more protection in law than a patient seeking cosmetic surgery, and breast augmentation in particular. That situation remains unchanged over a decade later despite the surgical profession, patients and the HoC desire to change it. Failure by Parliament to make the changes required is a bigger scandal then PIP because hundreds of thousands of patients having been exposed to unnecessary risk for decades due to lack of regulation in the UK.
The surgical profession continues to support better regulation.
CE marking of implantable devices and of machines used in cosmetic medicine indicates the standard of production, not of efficacy or safety.
All devices implanted, potentially, have the same life span as the patient. The patient is, therefore, being used as an experimental animal with any implant, be it a heart valve, an intraocular lens, hip joint or a breast implant. No laboratory animal has the life span of the human.
There is no regulation of who can perform cosmetic surgical procedures in the United Kingdom. In France, Denmark and Singapore the surgeon has to be a plastic surgeon to perform cosmetic surgery. In the United Kingdom, I cannot work as a GP by law, but a GP or any doctor with minimal training in surgery is allowed to perform invasive cosmetic surgery. We would not allow a GP, or a doctor with little surgical training to perform neuro or cardiac surgery but the GMC (General Medical Council) and the law have double standards when it comes to cosmetic treatments, including surgery.
In Germany, only doctors and registered nurses can deliver injections that perforate the skin.
Proposed mandatory registration of cosmetic surgeons and practitioners
There are attempts at self-regulation in cosmetic surgery and medicine thorough voluntary registers (JCCP and the Intercollegiate Cosmetic Surgery Certification Scheme) in Great Britain and Ireland. Registration should be made compulsory to protect patients. Protecting patients is more important than protecting practitioners’ incomes.
The GMC has refused to accept that core and specialist surgical training is required to perform cosmetic surgical procedures. Any surgical procedure has complications and the surgeon must be able to recognise and instigate treatment for those complications. Training as a doctor to full GMC registration does not equip the individual to perform surgery, let alone deal with the complications.
The intercollegiate Cosmetic Surgery Certification Scheme is now the first ‘Board Certification’ in the United Kingdom, certifying fully trained and experienced cosmetic surgeons. The scheme also applies in a slightly different form in the Republic of Ireland.
Proposed changes to company law to protect patients
The legal practice of putting a viable cosmetic surgical or medical company into liquidation (‘Phoenixing’) leaves the company’s patients with no legal recourse or legal requirement for follow up. However, the clinic can reopen the next day with the same staff, database and facilities under a new holding company. PIP, the ‘old Harley Medical Group’ and others have used ‘Phoenixing’ to protect their assets at the expense of their patients’ safety. This practice puts patients at great risk and should be made a criminal offence in healthcare.
Proposed changes to advertising of cosmetic procedures
With a high proportion of patients seeking cosmetic surgical and medical procedures suffering from Body Dysmorphic Disorder5 it would appear advertising such procedures is no longer ‘socially responsible’. Therefore, the advertising of cosmetic surgical and medical procedures should be made illegal and the law upheld by the Code of Advertising Practice and policed by the Advertising Standards Authority.
• Are patients given enough information on the risks associated with implants and/or cosmetic surgery in general as to be able to give informed consent to procedures?
There is high sales pressure in cosmetic surgery and medicine. Good Medical Practice from the GMC is aimed principally at doctors working in the NHS and the scant recommendations are inadequate to protect patients from unscrupulous practitioners in the independent sector.
With ‘want not need’ surgery, the balance of risk and benefit, including the long term financial implications and the inability to reverse the changes must be explained to patients and should be included, explicitly, in all informed consent for such procedures.
Intraocular lens replacement surgery for refractive errors in young people is becoming popular. It is, arguably, also a cosmetic surgery procedure and should be regulated as such. The lifelong implications and the complications of revision intraocular lens replacement must be explained in detail to patients and be included in informed consent.
• What responsibility does the state have to reverse medical errors, specifically in response to serious patient safety scandals linked to medical implants (for example PIP and mesh)? What responsibility does the state have to reverse medical errors carried out by private providers?
CE marking only relates to the standards of production of a device, not to its efficacy or long term safety. This issue lay at the heart of both the PIP and Mesh scandals.
At present, if a CE marked implant is found to be defective, for example the metal on metal hip prostheses, the government has to shoulder the bill, in both the NHS and private sector.
However, the PIP scandal was caused by the criminal acts of M. Mas. In this type of situation, the criminal is principally responsible through Tort. The competent body which failed to expose the illegality is also legally responsible.
For situations where there was no illegality, the EU should also be responsible for not ensuring extensive safety testing is included in CE marking. The manufacturer should also shoulder some responsibility for not testing the efficacy and safety of their product fully. That appears to be justifiable on moral and legal grounds
Now that the UK has control of our own regulatory framework, the legal responsibility can be passed on to the manufacturer with the requirement that they must all be members of a Captive insurance scheme, which would indemnify for future problems that can occur with any implant, beyond normal wear and tear (see below).
The new system of regulation and product marking of implantable medical devices in the United Kingdom should, therefore;
a. Incorporate safety testing for all implantable devices.
b. Any device implanted into the human body should be a prescription only device, including dermal fillers.
c. Lifelong registration and follow up for all implantable medical devices should be mandatory.
d. Mandate all manufacturers of implantable medical devices become members of a Captive Insurance Scheme that would indemnify for future design issues, like the metal on metal hips, and for illegal acts such as PIP.
Proposal for mandatory medical indemnity Insurance
Mandatory medical indemnity insurance must be based on the risk profile of the individual surgeon/doctor/ nurse etc who perform implantation of medical devices appropriate to their training. This must include product liability insurance and the policy must not be discretionary, but insurance based and, at present rates, carry indemnify up to £10million for a single occurrence.
Proposal for mandatory revisions indemnity insurance
I declare a conflict in that I am the medical director of Sure Insurance Services ltd, a provider of insurance for the revision of cosmetic surgical procedures that develop following defined complications. The insurance is carried by the surgeon and not the patient. If a claim is made, the reimbursement can be transferred to another surgeon if the patient wishes. The insurance helps improve the patient’s peace of mind about what happens if complications do arise. The insurance covers the hospital costs of revision. The surgeon usually gives their time for free with cosmetic surgery revisions.
Proposal for a mandatory captive insurance scheme for implant manufacturers.
Implant manufacturers must all be members of a Captive insurance scheme to cross indemnify the risks of implant development and later problems that may arise, beyond fair wear and tear. This was under consideration over a decade ago but some of the larger breast implant manufacturers refused to partake and the scheme did not get off the ground. Willis ltd (now WTW ltd) were leading on the scheme. Such a scheme would pay for any future restitution required in the NHS and private sector for problems such as happened with the metal on metal hips and for situations, like PIP, where illegality was an issue.
Conclusion
I have spent my entire consultant career trying to make the cosmetic surgery market safer for patients. If I can be of assistance to the Committee on the issues and with my proposals, I would be delighted to help.
Nigel Mercer
5 April 2025
References
1. https://www.jprasurg.com/article/S0007-1226(04)00235-8/pdf
2. https://www.sunderlandecho.com/news/patients-left-off-breast-implant-registry-324797
3. https://digital.nhs.uk/data-and-information/publications/statistical/mi-breast-and-cosmetic-implant-registry/jan22-dec22
4. https://www.gov.uk/guidance/breast-implants-and-anaplastic-large-cell-lymphoma-alcl
5. Literature search of PubMed on (PIP breast implants) AND (rupture) AND (inflammation) AND (cancer) on 03/04/25
6. Body dysmorphic disorder.
https://www.jprasurg.com/article/S1748-6815(24)00733-2/pdf
7. Screening for BDD
https://pubmed.ncbi.nlm.nih.gov/39470820/
April 2025
Bibliography from PubMed Search on PIP implants; rupture; inflammation; cancer;
