A defective medical device is powerful enough to rewrite the destiny of people. It is 100 percent true in the case of Essure birth control devices. Many women who used these devices were pursuing Essure lawsuits against the manufacturer for the physical injuries they had sustained. The first set of Essure implant lawsuits was settled by the company. However, the women who are affected are waiting to pursue the claim.
Like the IUD ParaGard, a birth control device, Essure is also claiming that the device is safe and effective as a contraceptive device. ParaGard and Essure are two different types of birth control devices used by women in the U.S. However, both had landed the lives of the women who used them in trouble. This blog analyses the make and use of Essure and the pernicious side effects that ensued in Essure lawsuits and Essure lawsuit payouts. Let’s plunge into the blog to learn more.
Table of Contents
- 1 What is Essure, and How Does it Work?
- 2 History of Essure Birth Control Device
- 3 Medical Device Bills Emerged from Essure Complications
- 4 Essure Lawsuits
- 5 Sample Cases from the Essure Lawsuits
- 6 How do I Join the Essure Lawsuit?
What is Essure, and How Does it Work?
Essure is a permanent birth control device used by women. Essure inserts are like a 4-centimeter coil made from stainless steel, nickel, titanium, platinum, polyethylene terephthalate (or PET) fibers, and silver-tin. The manufacturers claimed that their device was 99.3 percent successful in preventing pregnancy.
The Essure is simple to implant because it does not require any surgical intervention. The flexible device can be inserted into the fallopian tube path through the vagina and cervix. Scar tissues will form around the device in three months, blocking the path from the uterus to the fallopian tubes. The eggs are prevented moving from the ovaries to the uterus due to the blockage in the tub. Thus, it successfully creates a barrier keeping the sperms away from the eggs and prevents conception.
Essure contains no hormones that interact with the body and does not require general anesthesia during the procedure. However, women must endure pain during and immediately following the procedure. Some of the most common side effects of the birth control device are nausea, vomiting, bleeding, dizziness, cramping, and pelvic discomfort.
Along with these side effects, approximately 8% of the women reported device failure because it did not prevent pregnancy, which was the primary goal of implanting the device. Some women have reported that the Essure implant corroded and migrated inside them, exposing them to nickel poisoning, inflammation, and uterine and other organ damage.
History of Essure Birth Control Device
Conceptus, Inc. developed and manufactured the Essure birth control system. The FDA tested it between 1998 and 2001 and approved it in 2002 through the FDA’s Premarket Approval Process. Conceptus was purchased by Bayer AG in 2013, and since then it has been a subsidiary of Bayer.
Since the date of approval, the FDA began receiving reports of adverse events related to Essure medical implants. In February 2016, the FDA ordered Bayer Healthcare to conduct a new clinical trial, and in November 2016, it received a “black box” warning label. According to the reports, Bayer Healthcare paid out $413 million in legal settlements related to Essure in 2017.
The U.S. Food and Drug Administration (FDA) received 67,643 Essure-related medical device reports by December 31, 2021, including 26 deaths. The complaints reported to the FDA were as follows:
- Abdominal pain
- Autoimmune disorders
- Bloating or gastritis
- Device fragment in the body
- Organ perforation
- Device breakage
- Device migration
- Pregnancy due to device failure
- Difficulty during insertion and removal
- Ectopic pregnancy
- Dyspareunia (difficulty or pain during sexual intercourse)
- Variations in weight
- Nickel allergy
More than 80 percent of the devices were removed due to the pain. Among the reasons for the removal, the percentages are distributed as follows. Pain: 60 percent, Genital hemorrhage: 14 percent, Device dislocation/migration/expulsion: 12 percent, Perforation: 11 percent, Suspected allergy to metals and Device breakage: 3 percent. Most of the women had to undergo one or more surgeries like a hysterectomy to remove the device.
Many women in the U.S and other nations have complained of severe adverse effects. The Essure Problems Facebook page was started in 2011 by Angie Firmalino. Women who experience implant-related side effects are supported by the group. It also promotes the use of safer medical equipment. In order to warn other women and share their tales, some of these ladies made an appearance in the 2018 Netflix documentary ‘The Bleeding Edge’.
In 2018, the FDA imposed sales restrictions such as getting the patients’ signature after they were informed of the risks at the time of purchase, as well as other sales restrictions. Followed by that, there was a decline in the sales of Essure devices. By the end of the year, after being faced with numerous Essure lawsuits by the affected women, Bayer announced that it would discontinue production and sales of the Essure.
Bayer maintained that its device was extremely safe and effective and that the reason for halting production and sales was purely financial. They stated that the previously purchased implants were to be used within a year of purchase, and the remaining devices could be returned to Bayer. In America, the window for new Essure implantations closed at the end of 2019. However, they did not recall the device.
Bayer faced lawsuits for the following long-term side effects:
Following that, Bayer disclosed in 2020 that it would pay $1.6 billion as Bayer Essure lawsuit settlement amount to resolve almost 39,000 Essure lawsuits brought by women who claimed to have suffered significant device-related ailments. In the settlement agreements, Bayer makes no admission of guilt or responsibility.
Medical Device Bills Emerged from Essure Complications
E-Free Act (H.R. 3920)
The primary goal of the bill is to require the FDA to cancel Essure’s PMA (premarket approval) status. When Essure harms people, PMA shields Bayer from responsibility, and Bayer too hides under the pre-emption.
Ariel Grace’s Law (H.R. 5403)
This bill amends the Federal Food, Drug, and Cosmetic Act to state that the federal prohibition on state or local requirements for medical devices does not affect an action for damages or a person’s liability under state law. This bill takes effect retroactively and applies to pending civil actions. Bipartisan legislation known as Ariel Grace’s Law seeks to eliminate federal pre-emption safeguards for any Class III PMA devices that endanger patients. It has the name of a stillborn child named Ariel Grace Burrell. It is thought that a misplaced or migrating Essure coil ruptured the amniotic sac and resulted in the delivery of a stillborn baby.
The 2016 Medical Device Guardians Act (H.R. 5404)
This bill is proposed to amend the Federal Food, Drug, and Cosmetic Act to require physicians and physician’s offices to report on certain adverse events involving medical devices and for other purposes. Physician reporting of adverse occurrences is optional under present rules and regulations, and that is made mandatory under this bill.
We have seen that many women filed Essure lawsuits. Let’s turn the pages of the course of Essure device lawsuits here. Since Essure was given federal approval by a significant body, the FDA, it protected Bayer against accusations that it failed to adequately inform the public of physical harm. Bayer took this pre-emption as its protective gear from the Essure lawsuits.
Essure cases against Conceptus and Bayer became more challenging due to the pre-emption debate, and several judges dismissed cases due to pre-emption. However, notwithstanding pre-emption, Essure lawsuits were permitted to continue by the Alameda Superior Court Judge Winifred Smith in California, and he handled more than 13,000 Essure lawsuits as of March 2018.
Other judges dismissed cases because the claims did not meet court requirements. For example, in January 2018, St. Louis-based U.S. District Judge Stephen N. Limbaugh Jr. dismissed 92 of 95 plaintiffs in a federal Essure case.
The allegations against Bayer in the Essure lawsuits were that they
- Knew the risk beforehand
- Failed to warn the consumers of the risks and side effects
- Were negligent in training the medical practitioners on the implant
- Were negligent in risk management
- Breached warranty
Damages Claimed in Essure lawsuits
- Past and present medical care expenses
- Costs of surgical procedures and follow-up treatment
- Severity of complications
- Lost income
- Loss of future income
- Pain and suffering
- Emotional distress
- Punitive damages
Sample Cases from the Essure Lawsuits
You may know by a handful the whole sack- is a proverb that goes well with these sample cases from the Essure lawsuits to get to know the size of the iceberg that is hidden below.
Stephanie Bailey got her Essure imp-lant on November 16, 2010. She experienced long-lasting migraines, joint pain, pelvic pain, and numbness in her lower extremities. Following the serious symptoms, she had to undergo a hysterectomy to remove the Essure birth control device. However, unfortunately, she lost her life. Her husband, Bradley Bailey, filed a lawsuit for damages like the cost of all medical, hospital, emergency care, and burial expenses; and the loss of love, companionship, comfort, care, assistance, and affection. Her husband came to know of the risk of Essure only when the FDA issued a warning against Essure in 2016.
Theresa Cormier had an Essure implant in December 2003 and underwent complaints of fibromyalgia, chronic fatigue, and acute pelvic discomfort. Due to Essure, she required a hysterectomy and bilateral salpingo-ophorectomy. On July 17, 2008, Kim Myers received her implant. She experienced acute pelvic pain following Essure implantation. Due to Essure, she was forced to have a hysterectomy. In October 2011, Mandy Labonte underwent implantation. After receiving Essure, she started experiencing acute menstruation changes, anxiety, hair loss, bloating, decreased libido, skin irritability, terrible headaches, and depression. Essure caused her to need a hysterectomy. These three plaintiffs were a few among the women who joined Bradley Bailey in pursuing Essure lawsuits.
Heather Walsh had her Essure implanted in 2008, and she was hospitalized four times in the following two years due to severe pain, fever, and fainting episodes. Her CT proved that her Essure device had migrated and lodged behind her colon, and instead of two coils, three were seen in her CT. She had undergone a hysterectomy and was experiencing autoimmune disorders due to that. She sued Bayer in 2015, alleging that Bayer failed to warn her of the risks.
Sarah Dzikowicz received Essure in September 2006. She continued to have problems such as painful and heavy periods, unexplained weight gain, autoimmune conditions such as chronic fatigue syndrome, dental troubles, gastrointestinal complaints, and mental fog pertaining to the implant. Dzikowicz eventually had a vaginal hysterectomy to remove the implant in 2015, but she later learned that, despite the surgery, one Essure coil had managed to stay inside her body. The documentary, The Bleeding Edge alerted her of the risk, and in 2020, she had it removed through another surgery.
Measures Taken by the FDA after Essure Lawsuits
The FDA is taking all possible measures it can to assure the safety of women by trying to understand the long-term complications of Essure. Thus, it can assist patients and healthcare professionals. The agency continues to gather long-term safety data from women who have received Essure along with clinical data from post-market surveillance to do the analysis.
The FDA noted that it had taken a number of actions with regards to Essure, both before and after it was taken off the market, including looking into patient complaints, ordering Bayer to conduct its post-market study, issuing guidance on the device, updating labeling to warn of risks, and ultimately restricting sales and distribution of Essure. This was done in order to ensure that any woman thinking about getting Essure receives and has complete access to information regarding the advantages and risks of the procedure.
It has requested women who are still successfully having the implants in their bodies for years continue and is expected to collect the details of the long-term effects. It wants the women to undergo blood tests to assess whether there could be immunological reactions to the device and whether these findings are connected to the Essure-related illnesses that patients have experienced.
Liability in Essure Lawsuits
Essure lawsuits were trialed under the defective product liability category of personal injury litigation. Defective product lawsuits are filed when a person is injured because of a manufacturing defect, design defect, or (as in the apparent case of Essure) the manufacturer’s failure to warn of a product’s dangers. Essure was sued on the following grounds:
- Essure was manufactured without a license for three years.
- Essure’s risk assessment was incomplete.
- When complications arose, there was a lack of attention to detail.
- Failure to report to the FDA 16,047 complaints of potential device malfunction.
- Providing Essure devices to untrained physicians for resale.
- Since 2005, Essure implants have been manufactured in an unregulated facility.
- Essure has materials not approved for use.
How do I Join the Essure Lawsuit?
Since Bayer had settled the first set of Essure lawsuits, the graph has not had many movements. However, if you or your loved one has an Essure implant, suffered pain or injuries, and underwent surgery to remove the device, contact an experienced lawyer to know the chances of proceeding with a lawsuit. Though the FDA gave a black box warning in 2016, the women who had received the implants before that are still at risk of injuries.
If your attorney shows a thumbs up, do the following. If you doubt that some of your symptoms are related to your Essure implant, consult your physician to check your symptoms and confirm the injury. If needed, you can undergo surgery to remove the device. Collate all the medical reports regarding the implant and the symptoms you have experienced after the implant. Keep each and every piece of medical report safe and hand them over to the experienced Essure lawsuit attorney to solidify your claim.
Your years of treatment and suffering might have piled up a voluminous mountain of medical records. Never worry! A medical record review company will have expert professionals to peruse your medical charts and scoop out the valid ones that can turn the lawsuit in your favor. LezDo techmed is also a medical record review company that can handle as many volumes of medical records and compress them into a crisp medical record summary with all the crucial data to help you.
To sum up,
Though Essure is out of sight, it is not out of the minds of women who suffered due to it. Women have all the rights to be informed of all the risks of the device they are going to have as part of their body to decide if they choose that or not. Bayer has acted negligently in hiding the dangers of the device and became the sole culprit behind their injuries. Though the manufacturers had stopped the sales, what they had sown must be reaped by them.
Though they had settled the first set of Essure lawsuits successfully, the pending lawsuits are still dangling over their head. If there is any latest Essure lawsuit news, we will update you. So, keep in touch….