The safety of a contraceptive implant device is being questioned
Health experts have expressed serious concern over the safety of Essure; a permanent non surgical contraceptive implant.
In the UK, Essure was approved for use by the National Institute for Clinical Excellence in September 2009 and is available on the NHS. It consists of flexible coils which are inserted 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.
However a BMJ study published on 23 September 2015, found that women implanted with the device had a 10 fold higher risk of needing another operation.
On 24 September 2015, the FDA held a meeting with the Obstetricians and Gynaecology Advice Panel to discuss scientific data regarding Essure’s safety and effectiveness.
The Panel recommended:
- Developing a protocol that includes interoperative imaging to ensure correct device placement
- Establishing guidance for practitioners to be able to identify long-term complications earlier
- Supporting early intervention analysis if abnormal bleeding occurs following the procedure
- Requiring a checklist or signed informed consent form to ensure clinicians discuss risks, benefits, and alternatives
- Developing a patient registry for tracking the rate of pregnancies and adverse events
- Strengthening training programs for device implantation and placement
- Developing training for removal
The committee also recommended better monitoring and earlier removal of the device when it causes problems.
During the public portion of the discussion, more than 30 patients spoke, describing severe abdominal pain, bleeding irregularities, migraines, painful sex, autoimmune disorders, extreme fatigue, psoriasis, perforation of the uterus, and even narcolepsy and cataplexy—all symptoms they attribute to the implantation of the Essure System.
The FDA will continue to monitor the products safety but have opened up the report for public comment until 24 October 2015.
In its 13 years on the market, and over 10,000 women implanted, 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, 5 foetal deaths and 4 adult deaths from infection and uterine perforation.
Law suits have already been filed 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 current support group “Essure Problems” has over 19,413 members on Facebook.
Tamlin Bolton, from law firm Leigh Day, which is examining claims on behalf of a number of British women in relation to Essure, said:
‘This study is extremely concerning for women with this device.
‘Though the outcome of the FDA decision is useful, we eagerly await further research into the safety of this device. If Essure is taken off the market in the USA, we would strongly advise the UK Government to rapidly follow suit to ensure women are not harmed by this device.
We are currently investigating a possible group claim."
If you or anyone you know has received Essure and suffered injuries or consequences from the device – please contact Tamlin urgently to discuss your potential claim.