Brazil based company, Silimed, the third largest manufacturer of silicone implants, has had its CE certificate for its medical devices suspended by the Medicines and Healthcare Products Regulatory Agency (MHRA), the UK regulator of medical devices, and other European product healthcare regulators. The CE certificate is a requirement for many products in the European Economic Area and confirms that the products meet EU safety, health or environmental requirements.
Silimed’s implants are used in breast, pectoral, penile and testicular implants, and vaginal stents. Its products are distributed to more than 75 countries worldwide and at least 13,000 Silimed silicone implants have been supplied in the UK since 2010. Many of these are thought to have been used in cosmetic breast enlargement surgery.
The concerns over the safety of Silimed’s implants arose during a recent audit of Silimed’s manufacturing process which revealed contamination. Investigations between the MHRA and other European regulators are on-going and the MHRA has advised that "for the moment there has been no indication that these issues would pose a threat to the implanted person's safety". However, surgeons have been told to stop using Silimed manufactured implants and the British Association of Plastics, Reconstructive and Aesthetic Surgeons (BAAPS) has told its members to contact patients who may be affected.
Arran Macleod, a member of the Penningtons Manches product liability team said: “Although it is not yet clear whether the contamination is dangerous and could pose a health risk to affected patients, this alert will raise alarm for many who remember the PIP breast implant scandal in 2010. Depending on the outcome of the MHRA’s investigations, the implications of this contamination could be far wider reaching as Silimed implants were used more extensively in NHS surgeries throughout the UK. Many patients who have had various types of cosmetic or plastic surgery could be affected.”