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PIP implants - removal and replacement

Note from Mr Simon Lee on PIP Implants

"I have never used PIP implants on any of my patients and am happy to offer removal for those who have had them put in elswhere, with or without replacement.
I have heard of some women who have gone back to their original clinic who have been told over the phone without a Medical consultation that they can have them removed for free but would need a second operation to put them back in and up lift their breasts and that they will need to pay for the second procedure. Removal and replacement with reshaping can nearly always be done together in the same procedure. If you would like to discuss how I might be able to help, please contact me "

Please also see below an article written by Mr Simon Lee on PIP implants

PIP Breast Implants - No proven health risk but probably best removed.

There are now more than 40,000 women in the UK who have received PIP breast implants from the French company Poly Implant Prosthesis.  We now know categorically that this implant was originally passed as safe for human implantation by both French and British regulators and became defective at some point between 2001 and 2010.  There were clear and deliberate actions by the French company to cut costs in the manufacturing process. They switched from human grade silicone to a variety designed for mattress filling and changed the makeup of the protective outer envelope.  Investigations by the French regulator has demonstrated that the mattress filling silicone used, is more inflammatory than human grade silicone when in contact with human breast tissue and that the rupture rate for the implants is suspiciously high.

The Medicines and Healthcare products Regulatory Agency of the United Kingdom (MHRA) and the British government are not recommending routine removal of these implants for health grounds.  However, this is contradictory to the French government and their regulators advice that say they should be removed for health grounds. 

It is a very worrying time for any woman in the UK who underwent breast augmentation between 2001 and 2010 and received PIP implants. Official advice has not been clear, but the important message is that if you did receive PIP implants and have not already detected a problem then there is no reason for immediate concern.  There has been no proven risk of increased cancer, sarcoma, or lymphoma associated with PIP implants and this is most unlikely ever to be a picture that emerges.

That's helpful but what about those women who have noticed problems or are simply worried. Lets face it who can blame anybody for having significant concerns, physical symptoms or not?

I can understand any women with PIP implants wanting to have them removed immediately but I would strongly advise that you see a reputable Plastic Surgeon and would reassure all that there is no immediate danger.

Anybody who has undergone breast augmentation with silicone implants should have been advised by their surgeon at the time of the various risks involved prior to consenting to their operation.  These include all the normal and general risks associated with undergoing general anaesthesia and of course complications of the operative site such as scarring, bleeding, and infection. The specific risks associated with implants should also have been discussed.  These include rupture of the implant and a capsular contraction where the normal thin soft pliable layer of scar tissue that develops around the implant becomes thickened and hardened and at its worst starts contracting and squeezing in on the implant. 

Rupture of an implant is an extremely rare complication with good quality (usually means expensive) implants and the best manufacturers offer a lifetime warranty, offering a replacement implant if it ruptures under normal circumstances. It becomes apparent because of a change in shape or size or a palpable ridge.

Capsular contraction can be associated with a ruptured implant, but can also occur around any implant regardless of rupture or its quality.  Clinical series vary, but capsular contraction rates can be as high as 10% down to as low as 1% depending on length of follow up, degree of capsular contraction included in the patient group and the surgeon.

Advice. If you have noticed a change in your breasts see a Plastic Surgeon and have your implants removed. Soon not urgently, do not panic. MRI scans or ultrasound may not be as sensitive as clinical examination by an experience surgeon so see your surgeon first.

If you have not noticed a change then you have more time. There is no absolute need to have them removed. Take advice but I think on balance in the long run they are better out than in.

Taking them out is relatively easy but most women had them put in for very legitimate reasons. See a reputable Plastic Surgeon who can advise on good quality replacement implants or reshaping using uplifting techniques and fat filling using your own fat cells.

The NHS has offered to remove and replace all PIP implants they put in. I believe all reputable surgeons and organizations will do the same. So far however any body operated on by any of the other providers is not in such a good position. If the surgeon or organisation responsible does not remove them then the NHS will. They will not replace the implant or reshape the breast if required.

Although for many years it has been recognised that the PIP implants were at the bottom of the market and that their rupture rate was high, it has never been clear whether this was at an unacceptable level.  The mass providers in the market have used thousands of these implants because it helped keep their costs down whereas the higher quality providers used very few. It is relatively easy for the NHS and these high quality providers to say that they will replace PIP implants for free since the uptake with these organisations was very low. Most accredited plastic surgeons have always been reluctant to use them. The numbers of implants involved is therefore small, but it is very different for the mass providers. To make the same offer would have significant economic consequences.  Nonetheless the duty of care for a doctor and a clinic is paramount to the practice of medicine for any GMC registered doctor.

I must admit that I do feel slightly sorry for these commercial organisations. The PIP implants were cleared by the British regulators for use in implantation and were CE marked for that purpose. I believe it is the French regulators who have the biggest number of questions to answer since PIP altered the implant and it slipped through the French safety net. Therefore, the fact that some organisations have put in more than 10,000 of these does not actually represent a breach of care at that time. There is however an ongoing duty of care which needs to be adhered to.

Cosmetic patients are a group of potentially vulnerable patients who need handling with sensitivity and impartial advice rather than being seen as a market to exploit.

It does bring out some quite significant concerns facing the entire cosmetic industry in the UK since it has been poorly regulated for a long period of time.  European doctors for example who are not permitted to perform certain cosmetic procedures within their own country have been able to infiltrate quite substantially the cosmetic market in Britain. Our regulations do not prevent them from performing these operations or "minimally invasive procedures in the UK. The journey time from Brussels or Paris to London on the Euro star is after all only 2 ½ - 3 hours.

The American public are very educated with regards to checking out their surgeons' qualifications and experience. In the United States most plastic and cosmetic surgical organisation and websites are run by fully accredited and board certified plastic surgeons. Their qualifications are widely and obviously placed within all adverts.  In the UK this is not the case and in fact less than half of cosmetic surgical websites market surgeons who are specialists and their qualifications are nowhere to be found on the website.  It is true that in the UK most patients undergoing cosmetic surgery have spent more time choosing their carpets than choosing their plastic surgeon.

Any fully accredited and formally trained Plastic Surgeon will be a member of one or both of the British professional organisations, BAAPS or BAPRAS.   

If you would like to discuss any issues relating to your PIP implants, please contact me and I will do my best to help you.

Simon Lee MBBS (London), MSc (London), FRCS (General Surgery, London), FRCS (Plastic Surgery, Intercollegiate Board - London, Edinburgh, Glasgow, Dublin. Member of BAPRAS and BAAPS.

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