The German multinational chemical and pharmaceutical company Bayer AG have confirmed several changes to the supply and distribution of the Essure device in at least two European markets, as well as in Canada and to the UK
Essure is a permanent sterilisation alternative available for women in the UK who might otherwise opt for tubal ligation.
The Essure device is made of two small insert coils which are made of a nitinol (nickel-titanium alloy) outer coil and a stainless steel inner coil wrapped in polyethylene terephthalate (PET) fibers. These coils are inserted into each fallopian tube during a non-surgical procedure using a catheter.
The devices embed by forming scar tissue to block each tube and ultimately prevent eggs from descending.
After 3 months, women will have a test to confirm that the insert coils have embedded properly, are located in the right place and are an effective form of contraception.
However, many women have complained about complications following this procedure and allegations have been made against the manufacturer that Essure has caused chronic pelvic pain, life-threatening ectopic pregnancy, device migration, perforation or tear of pelvic organs, and other complications, which, if removal of the device is necessitated, requires surgery in the form of a hysterectomy in some cases. Bayer has denied these allegations.
Recent developments to the change in supply and distribution of Essure include in Finland, where Bayer have announced that due to ‘business reasons’, Essure will no longer be distributed in that market, effective from 25 June 2017.
It is our understanding that Bayer UK have now confirmed in private correspondence to both firms and private individuals that they have plans to discontinue the sale and distribution of Essure in the UK from 1 September 2017.
Bayer UK indicated that commercial reasons are behind this development.
Further afield, in February this year Brazil’s National Heath Surveillance Agency chose to suspend the importation, distribution, marketing use and dissemination of Essure, as well as recalling units that had already been distributed.
In the USA, following a public meeting of the FDA Advisory Committee in September 2015 which resulted in the FDA recommending a new ‘Black Box Warning’ as well as a Patient Decision Checklist for physicians, Bayer must now undertake clinical studies to ascertain the prevalence of certain heightened risks.
The 1 year results of the mandatory clinical studies are due on 2 September 2017, with the final report not due until September 2023. The FDA continues to believe Essure is appropriate for the majority of women, although ‘some women may be at risk for serious complication’.
Most recently in Canada, Bayer has chosen to ‘voluntarily discontinue the sale and distribution of Essure… for commercial reasons’, affirming that this step ‘is not a recall of the product from the market’.
We understand that Health Canada, or Canada’s government department responsible for public health have recently carried out a safety review of the Essure in response to reports of adverse events.
Their safety review had identified risks associated with Essure which Health Canada stated ‘need to be better communicated and further monitored’.
They had stated their plans to work with Bayer in order to update the Essure product labelling to better inform women of these potential risks.
"The US FDA investigation in 2015 called for Bayer to undertake a post market clinical study of those women implanted with Essure. The 1 year report is due in September 2017 and we eagerly await the results’’, says Tamlin Bolton, the solicitor leading the investigation into Essure at Leigh Day.
‘’We welcome the withdrawal of Essure from the UK market and, in addition, we call for a full investigation of the safety and effectiveness of the device by the MHRA.’’