UK consumers alerted over FDA investigation into Essure contraceptive
Essure is a permanent birth control method for women. A doctor inserts soft, flexible coils into the fallopian tubes. Over a period of about three months, tissue forms around the inserts. The build-up of tissue creates a barrier that keeps sperm from reaching the eggs, thus preventing conception.
In the UK, Essure was approved for use by the National Institute for Clinical Excellence in September 2009 and is available on the NHS.
Essure was originally authorised for use in America by the FDA in 2002.
In its 13 years on the market, the FDA has received 5,093 complaints from women implanted with the device. Ranging from pain and severe cramps, to migration of the device, damage to internal organs, five foetal deaths and four adult deaths from infection and uterine perforation.
Law suits have already been filled in the USA and a Citizens Petition has been lodged with the FDA with over 2100 signatures from women wanting the device taken off the market.
The petition claims the original manufacturer of the device, Conceptus (purchased by Bayer in 2013) perpetrated fraud during the clinical trials, violated the terms of the FDA’s pre-market approval of the device and violated several federal laws in the manufacturing and marketing of Essure.
The FDA is due to hold a meeting with Obstetricians and Gynaecology Advice Panel on 24 September 2015 to discuss scientific data regarding Essure’s safety and effectiveness. They will “pursue actions as deemed necessary” once the discussions and review of the trial and testing data are complete.
The current support group “Essure Problems” has over 19,413 members on Facebook.
If you, or anyone you know, has received Essure and consider that you may have suffered injuries or consequences from the device – please contact us urgently to discuss your potential claim.
Bozena Michalowska, partner in the consumer law and product safety team, commented that, “should the FDA conclude that the safety of Essure is not such as patients are entitled to expect, claimants in the UK may have grounds to claim compensation against the manufacturer for damage caused by the device”