Following a ruling by the US Food and Drug Administration (FDA) on 29 February 2015 concerning the controversial female sterilisation device known as Essure, Leigh Day is now investigating claims by women in England and Wales implanted with the device.
The product, manufactured and distributed by the pharmaceutical company Bayer is the subject of ongoing legal action in the US and has attracted thousands of “adverse event” notifications collated by the FDA.
The FDA’s latest intervention requires Bayer to:
- Change its product labelling to add a Boxed Warning and Patient Decision Checklist to help ensure that all women receive and understand information regarding the benefits and risks of this type of device.
- Conduct a new clinical study to obtain more data about Essure’s benefits and risks.
The scope of the study ordered by the FDA has not yet been published, however it is anticipated that the study will look at the outcome of Essure in women that the FDA has previously identified as potentially “less suitable candidates for the Essure system”, including those with a medical history of the following conditions:
- Hypersensitivity to metal
- Autoimmune disease
- History of pelvic inflammatory disease
- History of abnormal uterine bleeding
Sarah Moore, a lawyer in the Leigh Day product liability team, commented that; “the FDA’s latest intervention is important; not only does it highlight shortcomings in the way in which the risks associated with Essure are currently labelled and communicated to patients, but it also compels Bayer to undertake further clinical studies.
This is a significant shift from the FDA’s position in 2013 which found that Bayer’s sterilisation device was adequately labelled and that all appropriate testing had been undertaken.”
The FDA’s latest announcement follows high profile research published in the BMJ during 2015.
The BMJ study found that, in comparison with women undergoing more conventional (laparoscopic) sterilisation, women implanted with Essure were 10 times more likely to have to undergo re-operation within a year of their Essure procedure.
Tamlin Bolton, solicitor in the Leigh Day team, commented; “the BMJ study published last autumn indicates that if you have an Essure implantation you are at considerably greater risk of re-operation than someone who opts for a more conventional sterilisation procedure.
"That is particularly significant given that Essure is marketed as a procedure that requires minimal surgical intervention and is targeted at women who want to avoid laparoscopic procedures.
"Many of the women who have already approached the Leigh Day team are reporting surgeries within a year of their Essure implantation. This pattern is consistent with the findings of the BMJ study”.
The UK’s medicines and healthcare watchdog, the MHRA, has yet to comment on the FDA’s latest intervention, and continues to recommend the use of Essure in patients.
The MHRA has however, on 29 February 2016, published a Field Safety Notice, notifying all health care providers that the product labelling for Essure will now be updated.