- Note: For breast augmentation surgery Sublimis Argentina uses Mentor, Eurosilicone or Nagor breast implants

- PIP breast implants were sold under a different brand name in Europe

The British Association of Aesthetic Plastic Surgeons issues a warning to women who have gone abroad for breast augmentation – following reports of implant rupture from patients who never suspected they were given controversial devices now taken off the market. PIP implants, it has emerged, were being sold under a different name in some of the most popular cosmetic surgery tourism destinations around Europe, regularly visited by British patients seeking low-cost procedures.

It has been estimated that around 50,000 women in the UK have Poly Implant Prothese (PIP) breast implants, but the discovery that the fraudulent devices were also sold in countries such as Belgium, Poland and the Czech Republic under re-branded name ‘M-Implant’ by Dutch firm Rofil Medical means that the number of women who should be on the alert is much higher. Studies last year found that the company originally making the low-cost implants, which has since gone into administration, not only dispensed with a protective shell but used an untested gel, said to have been intended for use in mattresses.

- Breast Implants (no specific brand)

Although the French medical device regulatory authority (AFSSAPS) found no acute toxicity (cytotoxicity) effect on tissue, tests for genotoxicity (effect of the gel on DNA of cells) did not give a conclusive result and further extensive testing will need to take place.

PIP implants were known to have been popular with the larger domestic chains and commercial clinics because of their low cost. It has been estimated that 60,000 people travel out of the UK for medical tourism every year, and roughly a third of those do so specifically for cosmetic surgery.

Controversial breast implant gel not toxic

Preliminary Testing Shows No Evidence of Toxicity

London –  The British Association of Aesthetic Plastic Surgeons, welcomes the news from the Medicine and Healthcare products Regulatory Agency (MHRA) that the gel inside controversial PIP implants shows no evidence of chemical or genotoxicity (potential for cancer). The BAAPS, the not-for-profit organisation established for the advancement of education and practice of Aesthetic Plastic Surgery for public benefit, reiterate that any ruptured implants, of any kind, will still need removing.

A study earlier this year found that the company making the low-cost PIP implants, which has since gone into administration, not only dispensed with a protective shell from 2005 but was also using an untested gel, apparently intended for use in mattresses. Further tests are still being conducted by the French Competent Authority (AFSSAPS).

According to consultant plastic surgeon and BAAPS President Nigel Mercer:

“We would like to praise the MHRA for their proactive response in conducting safety tests and are delighted with the results – that there is little risk to patients from the gel. Hopefully this will reduce the anxiety of patients whilst further studies are expected from France. Our advice remains that women with suspected rupture contact their surgeon and undergo an ultrasound and removal, as they would with any ruptured implant.”

European regulations for cosmetic surgery to be introduced

British Association of Aesthetic Plastic Surgeons to Help Set Guidelines

London – After years of calling for tighter controls in cosmetic surgery in Britain, top UK surgeons are delighted to provide key input at a new committee in Brussels, so that Europe-wide standards can finally be introduced in this sector. The President of the British Association of Aesthetic Plastic Surgeons (baaps.org.uk), the not-for-profit organisation established for the advancement of education and practice of Aesthetic Plastic Surgery for public benefit, has been invited to participate in the creation of these cutting-edge regulations.

The market of aesthetic procedures – known generally as cosmetic surgery, though it involves non-surgical treatments – has increased dramatically over the last years, including through the recession. The growing availability of travel, the Web and numerous financial payment facilities also mean that medical tourism in this area has also become a reality.

The CEN – the European Committee for Standardisation – has recently accepted the proposal from the Austrian Standards Institute (ASI) to create a new Project Committee, CEN/TC 403 “Project Committee- Aesthetic surgery services”, the aim of which is to elaborate European standards for aesthetic surgery services.  Other organisations involved include in this project include the Care Quality Commission, the Royal College of Ophthalmologists and the British Association of Oral and Maxillofacial Surgeons.

Statement regarding PIP implants warning from the MHRA

London – As the discovery that the substance inside a cut-price breast implant is not what had been tested initially to make its use legal, the British Association of Aesthetic Plastic Surgeons, the not-for-profit organisation established for the advancement of education and practice of Aesthetic Plastic Surgery for public benefit, warns the public that choosing a provider solely on price can backfire.

As the French company behind PIP implants goes into liquidation, consultant plastic surgeon and BAAPS former President Douglas McGeorge says; “There have been questions about the safety and efficacy of these implants in the past – but as they were a ‘cheap’ option they may have proven popular with the commercial chains. Although it is unlikely that anyone’s health is in immediate danger, this must remind everyone that price should never be the sole consideration when choosing a cosmetic surgery provider.”

According to Nigel Mercer, consultant plastic surgeon and BAAPS President; “Concerned patients should contact their surgeon to find out what implants they have. Only PIP implants are involved and as yet there is no evidence that the gel they contained is harmful and we understand that it will not leak into the body. ”

The Medicines and Healthcare products Regulatory Agency (MHRA) is in close discussions with the French Regulatory Authority for Devices (AFSSAPS) as the product has now been taken off the market, and will be indicating if follow-up of patients is required.