Date lodged: 14 February 2018
To ask the Scottish Government whether the Essure contraceptive implant has been withdrawn from the market at any time and, if so, (a) on what dates, (b) for what reason and (c) how many women underwent the procedure for an implant during this time.
Answered by: Shona Robison 6 March 2018
In August 2017 Bayer announced that Essure's CE mark had been temporarily suspended, stressing that this development was unrelated to product safety or quality. The Medicines and Healthcare Products Regulatory Agency (MHRA) subsequently announced, in September 2017, that Bayer had withdrawn the Essure contraceptive device from the European market. The MHRA stated that Bayer had taken the decision for commercial reasons.
It is understood that fewer than five women received the implant shortly after withdrawal of the CE mark though, for reasons of patient confidentiality, an exact number cannot be given. The women concerned, some of whom had already begun preparatory treatment, gave consent after being made aware of the withdrawal of the product's CE mark and were given an option to choose alternative methods.