Expert product liability lawyers investigating reports that coil-like device caused extreme pain and heavy bleeding among users
A group of British women are considering legal action after suffering severe pain and discomfort following the insertion of a sterilisation implant which has been subject to an urgent safety notice issued by makers Bayer.
A number of women have contacted expert product liability lawyers Irwin Mitchell following injuries suffered after each had the Essure implant fitted.
Irwin Mitchell has been instructed to investigate issues with the product, which according to the US Food and Drug Administration (FDA) requires a "black box warning", a reference to the labelling of products to call attention to serious or life-threatening risks.
Essure is a permanent form of birth control in which a spring-like implement is non-surgically implanted into the fallopian tubes, during a procedure called hysteroscopic sterilisation. Scar tissue forms around the device which prevents sperm from reaching and fertilising the eggs. The Essure device offers an alternative to more traditional sterilisation and is marketed as being less invasive to have installed.
Manufacturer Bayer issued an “urgent field safety notice” on February 29 2016, warning medical professionals not to perform endometrial ablation, a procedure to destroy the lining of the uterus) and an Essure fitting on a patient the same day.
The FDA saw more than 5,000 US women file grievances between November 2002 and May 2015. Among the issues raised were miscarriages, unplanned pregnancy, severe pain and bleeding and stillbirth. In the UK, the Medicine and Healthcare products Regulatory Agency (MHRA) is considering the new evidence and reviewing whether their advice needs to be updated.
A study published in the British Medical Journal (BMJ), conducted by experts from Cornell University in New York, said women who have the device have a 10 times higher risk of needing another operation, than women who had received conventional sterilisations.
One of the women instructing Irwin Mitchell to investigate legal action in the UK is Mother-of-one Jo Nodder, from Blackpool who had the Essure product fitted in June 2014 after she and her partner decided not to have any more children.
“I went to hospital to discuss my options and was told having Essure fitted was a minimally invasive procedure where it could be inserted during day surgery so I wouldn’t have to undergo an operation under anaesthetic,” she said.
But immediately after the implant was fitted, Jo, 40, began to experience severe pain.
“It was like a constant stabbing pain,” she said. “I was bleeding all the time but thought the implant just needed to settle down, so I left it for a bit.”
Jo eventually visited her GP where she was prescribed medication for the bleeding, but the tablets caused her to put on weight and did nothing for the pain.
“The whole thing had a massive impact on my life,” she said. “I developed insomnia which took its toll on my family as well as at work. As time went on the lack of sleep just got worse and worse.”
The pain and bleeding continued until Jo opted for sterilisation to her left side in February 2015 by keyhole surgery. She went on to have the Essure removed in May 2015 and has since had a full hysterectomy.
Jo says the ordeal has had a huge physical toll and with continued absences for surgeries and treatment, she was forced to abandon her career.
“I used to be constantly busy with an active home and social life. But with life increasingly governed by pain, I lost my confidence and the idea of going out would, and still does, leave me anxious.
“Over the past 18 months I’ve lost a lot of good friends and my relationship with my partner and my son has come under strain. I’m finding it extremely hard to come to terms with what has happened to me since I was fitted with this device and the surgery I required.
“I have felt unable to get any help as I thought nobody would believe just how much pain I was in. The last 18 months of my life have been a terrible ordeal and at times I’ve been fearful for both my sanity and my health. I’ve been left at a complete loss.”
Jo is now hoping to get answers about the Essure device to ensure no one else suffers as she did.
Our experienced medical negligence claims team will provide you with free initial advice on your compensation claim if you have suffered as the result of a defective or faulty medical product or medicines. View our Defective Medical Device Claims page for more information.