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Safety of female sterilisation method under scrutiny in US

US consumer rights campaigner raises questions about safety of Essure sterilisation method

25 June 2014

US Consumer Rights Campaigner, Erin Brockovich has called for greater awareness of the dangers arising from a permanent female sterilisation method called Essure, manufactured by Bayer PLC in the UK.

The Essure method involves a doctor guiding micro inserts comprising of metal coils into the fallopian tubes via the cervix. Tissue forms around the coils therefore blocking sperm from reaching eggs.

The Essure method is marketed as a simple non-invasive procedure which can be conducted in less than 10 minutes without the need for general anaesthetic.

Essure first received approval from the US Food and Drug Administration Agency (FDA) on 4 November 2002. Since that time approximately 750,000 women have undergone the Essure procedure worldwide.
In the UK, Essure received approval from the National Institute of Clinical Excellence on 23 September 2009 and is available on the NHS.

According to reports, many women claim to have suffered pain, nausea,bloating, and bleeding after having the device fitted. There have also been claims that the device has migrated resulting in perforated uteruses, colons and even the lining of the stomach.

A Facebook group called ESSURE PROBLEMS which now has 8,657members, was set up to allow women suffering as a result of Essure to voice their experiences with Essure.

Unfortunately, in the US Essure patients are unable to sue Bayer PLC for the problems they have experienced.
Essure is classified as a Class III device by the FDA and qualifies for pre-emption, which prevents legal action being brought against the manufacturer.

Class III devices are generally the highest risk devices and are therefore subject to the highest level of regulatory control. Erin Brockovich is leading a campaign to have Essure removed from the market, have the classification of Class III rescinded by the FDA and get the federal pre-emption laws changed.

In October 2013, the FDA reviewed patient reports of problems that were submitted to them as well as clinical literature, to determine what long-term complications may be associated with Essure more than 5 years after placement.

From November 2002-October 2013, the FDA received 943 reports of adverse events related to Essure. The most frequently reported problem being pain (606 complaints) and the most frequent device complaints being migration of the device with 116 reports, and patient device incompatibility e.g. possible nickel allergy with 113 reports.

The FDA considered that these issues were known through clinical studies and addressed in the Essure product information. The FDA concluded that there was no evidence in the literature indicating any new or more widespread complications definitely associated with Essure occurring more than 5 years after Essure placement. The FDA has stated that they will continue to monitor the safety of Essure.

Information was correct at time of publishing. See terms and conditions for further details.

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