ESSURE sterilisation device permanently withdrawn from the market in the European Union
The company Bayer Pharma AG has decided to permanently withdraw the ESSURE ESS 305 sterilisation device from the market in the European Union, as of 30.05.2017. The manufacturer confirms that women already implanted with this device may continue to use it and that its preventative removal is not necessary for women who are not presenting any symptoms.
Following the decision by the company Bayer Pharma AG to permanently withdraw the ESSURE ESS 305 medical device from the market in the European Union, the FAMHP would like to reassure patients implanted with this medical device. As the agency has not received any incident reports in Belgium concerning the ESSURE ESS 305 medical device between March 2014 and May 2017, and given the limited number of devices implanted in Belgium (16 devices sold in Belgium according to Bayer), the agency is upholding the company’s recommendations and confirms that the preventative removal of the medical device is unnecessary.
An assessment of the medical device by the French medicinal product agency (ANSM) has also shown that the benefit/risk analysis of the ESSURE medical device remains positive. Other studies have demonstrated that the risks associated with this medical device were equivalent to the risks related to other types of permanent sterilisation.
Based on the information received, the FAMHP believes it is not necessary to undertake any further action in Belgium.
Any patients implanted with the ESSURE ESS 305 medical device who encounter a problem potentially related to the device should contact their doctor for additional examinations and complete, with their help, the incident form available on the FAMHP website.
Communications issued by foreign competent authorities