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Essure
When taking medication for personal and private matters, we can only put our trust and faith in the doctors recommending those products and the pharmaceutical companies that manufacture them. This is particularly true of birth control, which we trust with our hormonal balance and our very ability to procreate and enjoy a fulfilling sexual relationship.
Essure is a birth control option that is marketed as the only ‘permanent nonsurgical procedure’ and an alternative to having your tubes tied. The manufacturers Bayer state that their product has a long history of being safe and effective and continues to market the product on that basis.
However, such claims have been called into question by countless women who allege that Essure caused serious and permanent damage to their health. Experts likewise see severe limitations in the safety studies carried out by the company. This has led to the FDA taking action by issuing a ‘black box’ warning for the device. Meanwhile, a congressional bill is seeking a recall of the product.
Women who underwent Essure procedures and have experienced health complications as a result should recognize their right to compensation. Taking legal action could lead to a settlement that can help unburden some of the emotional and financial strain that followed as a result.
What is Essure?
Essure is a coil insert made using a titanium and nickel alloy. This coil is designed to be flexible and is inserted into the fallopian tubes. Over the course of three months, scar tissue will form around the inserts and this creates a barrier to prevent conception.
Bayer claims that the product is 99% effective when used according to its guidelines.
Essure was granted FDA approval in 2002 but from then until 2015, the FDA received over 9,900 reports regarding problems with Essure. Among these problems, the most common complaints were:
- Severe abdominal pain
- Bleeding
- Fatigue
- Weight gain/loss
- Device incompatibility
- Heavy menses
- Menstrual irregularity
- Lack of effectiveness, leading to unwanted pregnancies and ectopic pregnancies
- Poor positioning of device
- Perforation of the fallopian tube, uterus and colon
The product is also known to have led to at least 26 deaths, which include four adults as well as several miscarriages and infants that died immediately after birth. In a more recent analysis of Essure’s negative effects, it was found that over 300 fetal deaths may have been caused by the product.
Regulation and Safety According to the FDA
The initial FDA approval for Essure was granted to Conceptus Inc., a company purchased by Bayer in 2013. One million of the devices went on to be sold worldwide, the majority of which were in the US. Since the introduction of the system, the FDA has also approved changes to the labelling on numerous occasions. This included a sensitivity warning for the nickel content in 2011, a warning about the risk of chronic pain and migration in 2013 and a ‘black box’ warning in 2016.
Following the thousands of complaints that ensued from women, the FDA held a meeting of its Obstetrics and Gynecology Devices Panel in 2015. The panel would go on to make a number of recommendations which included advice that women with allergies, hypersensitivity to nickel, autoimmune disorders, prior uterine surgery or chronic pelvic pain should avoid using the device.
The panel also accused Bayer of failing to collect data that could have predicted and avoided some of the risks to women. Panelists were keen to outline the shortcomings that were evident in Essure’s safety studies. A piece that was published by the New England Journal of Medicine saw doctors outlining malpractice in the pre-marketing approval of the product. Specifically, Essure was approved based on studies that were not randomized or conducted with proper scientific design (the studies were not ‘blind’).
An FDA panel member was reported to have stated during the meeting that:
“Although relatively low rates were reported in many of these publications, significant limitations must be taken into account when reviewing the data.”
One Bayer official told the panel that the company had received 15,000 reports of adverse effects from women in the US. These women gave powerful testimony regarding the health problems associated with the product and reported tumors, fatigue, muscle weakness, loss of bowel control, autoimmune failure, abscesses and more.
This all culimated in 2016 with the FDA ordering Bayer to conduct a new study of Essure post-marketing and that this would have to be “designed to provide important information about the risks of the device in a real-world environment.”
Has There Been a Recall?
With growing concern over Essure’s health risks, the product is still available at the time of writing. The FDA and Bayer have resisted the calls to recall the product. In November 2015 however, Congressman Mike Fitzpatrick introduced a bill that would call for a recall.
The bill states that “if the FDA and manufacturers of the device aren’t willing to remove [it] from market, the Congress will.”
One section of Essure’s website with the title ‘Real Stories from Women With Essure’ shows videos and anecdotes of women who have used the procedure. However, this section of the website fails to include any reports that are not wholly positive, thereby intentionally misrepresenting the product as being completely safe and efficient.
However, there is no shortage of less favorable testimony from women whose lives have been ruined or severely hindered by their use of Essure.
“There were days when I could not get up out of the bed except to crawl to the bathroom in tears. I felt less like a woman, less like a human. The only, only acceptable solution for the women suffering , the women and children who have died, the families torn apart, is for Essure’s pre-market approval to be revoked.” – says Rebecca H.
“I am in pain every day. Some days are worse than others.” – Cecilia B.
“I got Essure months after my 4th child was born. My periods have been heavier and irregular and I had been regular my whole life prior. My hair started to thin, fall out and has become brittle, I always have some random itchy rash on my legs, I have [debilitating] migraines, I have chronic pain especially lower back pain, pelvic pain and pain during intercourse, most mornings I feel like a bus hit me, I have to sleep on a heating pad nightly, moving it from my pelvis to my back. I have memory, concentration, confusion and mood issues. They diagnosed me with Fibromyalgia and ADHD both since the Essure procedure, none of these issues did I have prior, and they all came pretty quick and have not gone away with any treatments.” – Shanna
Finally, an anonymous FDA report reads:
“As I was having a procedure to remove the cerclage, which was one of the most traumatizing things I’ve ever had to go through in my life, the high risk doctor performing the procedure stopped abruptly and said ‘what the (profanity) is an Essure coil doing in her vaginal tract?’ The coil had never implanted in fallopian tube and was floating around inside of my uterus my whole pregnancy. The coil had perforated the amniotic sac causing it to rupture and causing me and my husband to lose our beautiful baby girl.”
Lawsuits and Eligibility
Women who have been so badly affected by the use of Essure should exercise their right to compensation and in doing so can help to prevent others from suffering similarly.
Many Essure lawsuits have already been filed against the company with many more expected. Lawsuits allege:
- That Essure is fundamentally defective
- That Essure carries an unreasonably high level of risk
- That Bayer demonstrated a failure to comply with federal safety laws
- That Bayer was aware of the side effects but failed to provide proper warning to customers
- That Bayer’s tests of Essure were insufficient
- That plaintiffs would have avoided the product had they been fully informed of the risks
- Negligence
If you have been implanted with an Essure device that led to negative health effects, then you too may be entitled to compensation and eligible for an Essure lawsuit. For the best chance of success, it is crucial to find a qualified and experienced lawyer to represent you in court. WFederal pre-emption law should protect women and with many cases already being successfully filed against Bayer, this is a promising sign for future legal action.
To find out more about your rights and how to take action against Essure, get in touch with a member of our team and we will happily discuss your case with no obligation to proceed.
Date:
October 25, 2016
Category:
Devices
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