The implications of the PIP implant scandal are still affecting many thousands of women in the UK and now another breast implant scare story has hit the media with the news that Silimed implants have temporarily lost their CE mark, causing their withdrawal both here and around the world.
Why have Silimed breast implants been withdrawn from use?
This does not just pertain to breast implants. All Silimed’s silicone implants, which include breast, pectoral, testicular and penile implants, have been suspended while regulators from individual countries perform extensive testing.
During an audit of the manufacturing process, sterile particles were discovered on the surfaces of their silicone implants. The issue is whether these sterile particles could potentially cause any health problems and how extensive this contamination is.
This news is bound to cause a great deal of anxiety for any woman who has had these implants inserted, particularly in light of the problems that occurred with PIP implants.
Why would my plastic surgeon have used Silimed implants?
Many of the leading surgeons in the UK have used Silimed implants, including past presidents of the British Association of Aesthetic Plastic Surgeons (BAAPS), an independent plastic surgery association that puts patient safety at the very forefront of their endeavours.
There are two guiding factors that a reputable plastic surgeon will follow when choosing implants to offer to their patients: safety and efficacy.
Safety: Silimed is one of the major silicone implant manufacturers in the world, supplying devices to more than 75 countries. They were the first non-USA based manufacturer to gain FDA approval for their silicone gel implants – the FDA approval process in the US is lengthy, arduous and requires a great deal of clinical data to support both the safety and efficacy of a product.
In the UK, any implant or medical device requires a CE mark before it can be used and this CE mark indicates that it has followed all European directives in terms of safety. PIP breast implants gained their CE mark by fraudulently claiming the substance in their implants was something it was not and there is no comparison to the situation with Silimed.
Efficacy: There are many advantages to using Silimed implants and they probably have the widest range of breast implants available. The silicone used in the implants is a specially designed, highly stable silicone gel that is very resistant to damage and the implants are less likely to change shape over time.
Their polyurethane foam coated breast implants also have a very low rate of capsular contracture – the manufactures state that only 1 – 2% of implants were found to have developed capsular contracture after 15 years due to its textured surface.
At the moment it is unknown whether these sterile particles present any risk or even that any of these ‘contaminated’ products will have been used in a cosmetic breast implant procedures in the UK and this is being investigated thoroughly by the regulatory body in the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA).
Their current statement is as follows: “for the moment there has been no indication that these issues would pose a threat to the implanted person’s safety.”
My feeling is that it is very unlikely that problems will be found with the Silimed implants. However it is completely right and proper that the regulators have immediately moved to address this issue. If you are concerned about anything raised in the article, please be in touch with my Leamington cosmetic surgery clinic by calling 01926 436341.