Thousands of women from around the world are coming forward to claim compensation following severe complications resulting from the Essure birth control implant. Many of these women have or may require further complex surgery or treatment in order to remove the device.
In the UK it is estimated that 100,000 women have been fitted with the Essure implant. If you have been fitted with the Essure birth control implant and have experienced serious complications you could be entitled to compensation.
For more information on how to make an Essure compensation claim contact Devonshires Claims medical negligence experts. Our solicitors provide a free case evaluation to determine if you have a potential compensation claim. We offer victims of the Essure implant a ‘No Win No Fee’ agreement. This means that you will not be charged any upfront legal costs in order to start your Essure compensation claim and if your claim is not successful, you will not incur any costs*. Contact our compensation experts today to discuss your case. Call us on 0333 900 8787, email firstname.lastname@example.org or complete our online form.
A Woman’s Experience of Essure
Jan Faukner was fitted with a birth control device in 2008. The non-surgical Essure device, which saw a coil inserted into her fallopian tubes, left the mother of five with serious health conditions and she is now campaigning to extend the time people fitted with mesh medical implants can claim compensation against manufacturers.
“The time limitations for bringing a claim against a manufacturer of mesh, Essure sterilisation and breast implants should be removed.
“It can take years for patients to develop symptoms and for clinicians and regulators to become aware of a problem. This means many miss the deadline to claim.
“To make a claim against the manufacturer, you have to be within three years of knowing that there was a problem with the medical device.
“Some don’t find out their problems are attributable to the device until many years down the line, after being investigated for other medical conditions that they simply do not have.
“Ladies have lost families, homes and jobs, all destroyed by a device they had been led to believe to be safe. How can the law for implants be the same for devices like your kettle?”
Jan has also set up a support group for women facing the same problems with Essure, Life After Essure UK.
How Does the Essure Birth Control Implant Work?
Essure is a permanent birth control device manufactured by Bayer in 2002. Essure was first approved in the United States by the Food and Drug Administration (FDA) in 2002 before being approved for use in the UK by the National Institute for Clinical Excellence (NICE) in 2009.
According to Drug watch, its effectiveness is estimated to be 99.3 percent. The procedure of inserting the coil implant into the fallopian tube is performed under a general anaesthetic.
The coil-like implant, after being inserted, encourages the scarring, thickening or development of scar tissue (fibrosis) which lead to the blockage of the fallopian tube. Once there is a blockage the eggs are prevented from reaching the womb thus making the user sterile.
A History of Essure Complications
- After the FDA approval in 2002, the device entered the market before significant long-term research could be done and adequate warnings of possible risks were not initially provided to women. In 2016, a black box warning was added to the label disclosing its risks.
- The European Union suspended sales of Essure for three months in 2017 in response to concerns, with Bayer fully withdrawing Essure from the UK market in late 2017.
- In July 2018 Bayer announced that it would no longer distribute or sell Essure in the US beyond December 31 2018 – describing it as a ‘business decision’ following a drop in sales. US doctors could still fit the Essure implants until the end of 2019, after which any unused devices were to be returned.
- In March 2021 over 700 women in Canada launched compensation claims following years of Essure complications. Despite not admitting liability, Bayer removed the device from the Canadian market in 2017.
- In July 2021 over 300 women in Brazil are set to launch compensation claims against Bayer. Bayer removed the device from the Brazilian market in 2019.
Dangers Associated With the Essure Implant
Although the device offers a permanent solution with a high chance of efficiency, adverse reports have been made over the years. Some of these reports claimed that it caused debilitating and chronic pain as well as other side-effects.
The three key risks associated with Essure implant include:
- An allergic reaction to the nickel in the coil
- The coil-like implant falling out of its position and implanting or damaging neighbouring organs
- The implant failing to prevent pregnancy
Although the risks are low, it may lead to the need for abortions, mental trauma, miscarriages and even fetal deaths. It is also believed ectopic pregnancy is a huge risk.
Side Effects Associated With the Essure Implant
Some of the side effects reporting by recipients of the Essure implant include:
- Internal bleeding,
- Ectopic pregnancy, where the embryo forms outside the uterus
- Difficulties removing the device
- Exclusion of the device through the vagina
- Punctures or Perforations in the uterus or uterine walls
- Perforation or tear in the colon
- Perforation of other organs caused by migration of a piece of the Essure device or the whole device itself
Some mild side effects include:
- Joint pain,
- Abdominal pain,
- Back pain,
- Weight gain,
- Pelvic pain, which can become chronic,
- Changes in the menstrual patterns
- Abnormally strong allergic reactions to known allergens,
- Allergic reactions to the metal in the Essure device,
- Vaginal bleeding,
- Metal toxicity
Essure Complications: The Statistics
- A 2015 study by Cornell University in New York showed that the Essure form of sterilisation, known as hysteroscopic sterilisation – had a “high risk” of complications. According to the research, women who had hysteroscopic treatment were 10 times more likely to need a repeat operation within a year when compared to women who received standard sterilisation (where fallopian tubes are tied or blocked via surgery).
- Between 2002 – 2017 the FDA received 26,773 medical device reports in the US – related to Essure . The most frequently reported problems were abdominal pain, heavier menstrual periods and menstrual irregularities, headaches, fatigue, and weight fluctuations.
- According to analysis from Bayer covering June 1 2020 – August 31 2020, there were 7,509 adverse Essure events reported to the FDA – which included:
- 7,332 serious injury reports, 104 malfunction reports, and 73 death reports.
- The most common patient problems reported included pain, perforation, foreign body/device fragment in the patient, pregnancy, and heavier periods.
- In March 2021 Bayer published a 2nd quarterly analysis of adverse events about the Essure implant. The analysis of social media posts between September – November 2020 noted 11,830 serious injuries, 45 malfunctions and nine deaths.
Essure Implant Compensation Claims
In 2020 the BBC reported that Manufacturer Bayer has already set aside more than $1.6bn (£1.2bn) to settle claims from almost 40,000 women in the US.
If you received an Essure implant and are suffering serious complications, you could be entitled to claim compensation. At Devonshires Claims our experienced medical negligence solicitors have supported women obtain compensation for a variety of gynaecological conditions. We provide No Win No Fee agreements so there are no upfront legal costs to start your Essure claim and if your claim is not successful, you will not incur any costs*.
For a free case evaluation of your potential Essure negligence claim, contact our experienced and compassionate medical negligence solicitors today. We will deal with your claim with sensitivity and keep you informed at every stage of the legal process. Call us today on Call 0333 900 8787, email email@example.com or complete our online form.