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*** LATEST UPDATE ON BANNED POLY IMPLANT PROSTHESES, PIP BREAST IMPLANTS ***
Poly Implant Prostheses (PIP) silicone breast implants are banned in the UK, those patients treated by the NHS will have their removal and replacement performed on the NHS free of charge after appropriate consultation, private patients should seek advice and treatment from their implanting clinic first, if this fails the NHS will offer removal only after appropriate consultation.
At the end of March 2010, the French medical regulatory authority (AFSSAPS) informed our own MHRA (Medicines and Healthcare products Regulatory Agency) that it had suspended the marketing, distribution, export and use of the silicone gel filled PIP breast implants manufactured by a French company. The French authority recalled all of these devices at that point.
On inspecting the PIP manufacturing facility, the AFSSAPS found that breast implants made by the company since 2001 had been filled with a silicone gel with a composition different from that used to obtain their original European CE Mark approval, making it illegal. This silicone was found to be non-medical grade.
This discovery cast much concern over the safety of the products and the MHRA advised all U.K. patients fitted with the PIP implants to consult their implanting surgeon if they had any concerns; whilst the British Association of Aesthetic Plastic Surgeons (BAAPS) urged all women fitted with the devices to undergo an ultrasound scan within the next six months, to determine whether there was any rupture or weakening of the implant.
Globally more than 300,000 PIP breast implants are believed to have been sold to 65 countries over the last 12 years, more than half of those went to South America. In the UK it is estimated to affect some 50,000 women. It has now also emerged that PIP implants were sold to a now bankrupt Dutch company and rebranded as Rofil-Medro or Rofil-M implants, estimated to affect a further 5,000 UK women. Additionally, many Brits who chose to go abroad for cheaper surgery to countries such as Belgium, Poland and the Czech Republic may also have received PIP implants by one name or another and be unaware of it. In the UK most patients treated were clients of the Harley Medical Group (the largest at 13,900 patients), Transform Group, The Hospital Group, Linia, BMI Healthcare, Nuffield and Spire, although other smaller clinics and independent surgeons used the implants too.
Following delays on the French side the UK’s MHRA decided to conduct its own toxicology tests into the gel contained within the PIP implants. More results on the exact composition of the implants and their potential rupture rates came to light at the end of 2011.
After the initiation of a speedy government review by the Secretary of State for Health, Andrew Lansley in conjunction with an expert group consisting of plastic surgeons and other scientists, a decision from the Department of Health came on Friday 6th January 2012.
In a statement, they said, “the group has concluded that the advice given by the MHRA still stands and that there is not enough evidence to recommend routine explantation of these breast implants.”
In relation to those women wanting to have the implants removed and replaced it said; “the NHS will replace the implants if the original operation was done by the NHS. We expect the private sector to do the same for their patients. If a clinic that implanted PIP implants no longer exists or refuses to care for their patient – where that patient is entitled to NHS services, the NHS will support the removal of PIP implants. Any NHS service in that respect would not include the replacement of private cosmetic implants. The Government will pursue private clinics with all means at its disposal to avoid the taxpayer picking up the bill.”
The NHS in Wales has announced that it will remove and replace implants for privately treated patients.
If you are unsure as to whether you have recieved PIP breast implants, please contact the clinic or surgeon who treated you to request your medical records, there should be no charge for this. Please consult your implanting surgeon if you are concerned about the PIP breast implants that you have. If the company who performed your operation is no longer trading, please seek help through the NHS by contacting your GP first.
Useful Links:
MHRA Safety Warning March 2010 - www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON076499
MHRA Safety October 2010 - www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON096755
Department of Health statement on breast implants and response to expert group report 2012 - http://mediacentre.dh.gov.uk/2012/01/06/statement-on-breast-implants/
Department of Health Interim Report by the Expert Group on PIP Breast Implants 2012 - https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/146906/dh_132101.pdf.pdf
Department of Health Final Report by the Expert Group on PIP Breast Implants 2012 -
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/146635/dh_134657.pdf.pdf
Consulting Room Blog - PIP Scandal Erupts in National Media - www.consultingroom.com/Blog/Display.asp?Blog_ID=250&Poly-Implant-Prostheses,-PIP-Breast-Implant-Scandal-Erupts-in-National-Media
BAAPS response to the report of the PIP implant expert group 2012 - www.baaps.org.uk/safety-in-surgery/1025
MHRA explanation on CE Marking and its regulation of PIP Breast Implants 2012 - www.mhra.gov.uk/NewsCentre/CON140699
Last Updated: January 2012
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