Silimed Breast Implants news update by Mr Alex Karidis…
As has become apparent from a notice from the UK’s regulatory agency the MHRA, there has been a suspension of the distribution of Silimed silicone implants following the regulatory authorities’ decision to review the company’s technical compliance at Silimed’s manufacturing base in Brazil. This was due to some concerns that were raised during an audit of the manufacturing procedures where a potential source of “particles” was identified in the laminar flow chambers used during the production of the implant shells. This is at present, a temporary suspension and largely precautionary. It is important to note also that as of present no incident has specifically occurred to suggest any health affects, and that the company’s long-term post market surveillance has shown no data of concern. However EU health experts are currently evaluating test results to establish if there is any potential health risks associated with particles on the surface of these implants. Furthermore there is no current need to explant them or for patients to adopt any specific procedure regarding already implanted devices. We will of course be monitoring the situation and heed any advice or conclusion given through the MHRA, and contact patients accordingly.
Should you however have any current problems or other issues with your implants, I would of course be more than happy to see you and review you in the clinic, as I do with all my patients and to give you advice accordingly. I hope this helps clarify the current position.
Kind regards Alex Karidis
