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The Medicines and Healthcare products Regulatory Agency (MHRA) jointly with European healthcare product regulators of member states has been informed of the suspension of the CE certificate for all medical devices made by the Brazilian manufacturer Silimed, this includes breast and other body implants. The Silimed brand of breast and body implants is distributed in the UK by Eurosurgical Ltd.
A CE mark or certification is required as a mark of conformity to manufacturing standards for all medical devices which want to be sold in the UK and Europe - they cannot be marketed without one. Having a CE mark means that a medical device meets the relevant regulatory requirements and, when used as intended, works properly and is acceptably safe.
The German notified body responsible for inspecting and issuing the CE certificate to Silimed, has recently carried out an inspection of the manufacturing plant in Brazil and established that the surfaces of some devices were contaminated with particles. Prior to this the manufacturer was last inspected in March 2014 and found to comply with all requirements. The current findings relate only to the most recent annual re-inspection.
The devices covered by the suspended CE certificate are silicone implants for plastic surgery including breast implants, pectoral implants, gluteal (buttock) implants, calf implants, facial implants and tissue expanders, implants for bariatric surgery including gastric bands and balloons as well as other implants used for urology and general surgery. (A full list is available from the MHRA announcement.)
The MHRA announced that it is investigating, in collaboration with other European regulators, and recommends that none of these devices should be implanted until further advice is issued. However, they are keen to emphasise that for the moment there has been no indication that these issues would pose a threat to the implanted person’s safety. EU health regulators have initiated testing of samples of products to establish if there are any health risks.
"There has been no indication at this time that these issues would pose a threat to patient safety. We are urgently investigating this issue and are working closely with our European counterparts. In the meantime we would recommend that people who have questions about their implants should seek advice from their implanting surgeon or clinic"; said MHRA Director of Devices, John Wilkinson.
In a joint statement, the BAAPS and BAPRAS surgeon associations said;
"The British Association of Aesthetic Plastic Surgeons and British Association of Plastic, Reconstructive and Aesthetic Plastic Surgeons have been informed that all implants by Brazilian brand Silimed have had their CE Mark suspended, due to a quality issue picked up during a safety audit. Plastic surgeons have been informed not to implant these devices until further assessments have taken place and the CE Mark reinstated - we are not aware of any documented patient safety issues. Surgeons from both BAAPS and BAPRAS are working closely with the Medicines and Healthcare products Regulatory Agency (MHRA) to further investigate the matter."
Nigel Mercer, BAPRAS President and a Consultant Plastic Surgeon said;
“Patient safety is our foremost concern, and both ourselves and the British Association of Aesthetic Plastic Surgeons (BAAPS) are working closely with the MHRA to fully understand the issue. There has been no indication we are aware of at this time that these issues pose a threat to patient safety, however we are advising our members to contact any patients who may be effected. Any patients who have concerns about their implants should seek advice from their implanting Surgeon or clinic. As more information is available, we will be giving further advice to our members, their patients and the MHRA on any clinical issues."
Such news is of course far-reaching, Silimed is the third largest global manufacturer of implants so other countries are also taking this news of the suspension of European standards conformity very seriously.
In Australia, the Therapeutic Goods Administration (TGA) is urgently investigating following this announcement, what, if any, action is required in Australia and will be testing samples of Silimed products in its laboratories. As a precautionary measure and in consultation with the TGA, the Australian distributor for Silimed (Device Technologies) has been contacting surgeons who have been supplied with these implants to recommend any planned implant surgeries be postponed. Device Technologies has ceased the supply of all Silimed products in Australia until the situation is clarified.
This news of course raises many eyebrows and has caused much media backlash already, coming only a few years after the scandal involving the Poly Implant Prothèse or PIP implants which were found to have been manufactured fraudulently using non-medical grade components and evaded capture by lying when notifying body inspectors came to visit. There are of course no similarities being made between the French criminal operation and the long-standing Brazilian Silimed company, it would appear simply having a short-term production problem, (we will find out soon enough), but no doubt this will not help an industry which already has a large number of victims who feel let down and poorly treated by a marketplace that was happy to sell them faulty PIP implants which had appeared to be CE certified.
Silimed said that it is working to solve the problem and hopes to have the CE mark reinstated as soon as possible. They are keen to point out that they are not recalling breast (or any other) implants, but just advising no ongoing use until further notice. They note that the particles discovered show low risk.
In a statement sent to surgeons they said;
"It is important to know that no incident has occurred and our constant, long-term post-marketing surveillance has shown no alarming data."
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