The U.S. Food and Drug Administration has received more than 5,000 adverse event reports about Essure since 2002. In 2016, Madris Tomes of Device Events found more than 10,000 adverse events in the FDA’s databases, including more than 300 fetal deaths. Many of these reports came after Bayer bought the rights to the device from Conceptus — its original manufacturer.
These Essure adverse events led thousands of women to file lawsuits against Bayer.
More than half a million American women use Essure to prevent pregnancy and may possibly be at risk of suffering complications. The system consists of two primarily metal coils that doctors implant in each fallopian tube. Scar tissue develops in the tube and prevents fertilization.
Bayer touts the device as a noninvasive form of permanent birth control that is nearly 100 percent effective and has a quick recovery time.
But thousands of women claim the device ruined their lives and caused them permanent injuries including autoimmune diseases, perforated organs and severe pelvic pain. Through social media, these women, who call themselves “E-sisters,” share their negative experiences with the device and information about lawsuits.
In 2017, Bayer reported it lost about $413 million in revenue in 2016 because of Essure lawsuits. In its annual report, the company reported more than 3,700 lawsuits had been filed over its Essure devices. By mid-October 2017, Bayer confirmed the number had skyrocketed to more than 10,600 lawsuits.
In September 2017, Bayer removed Essure from every market outside the U.S. It said the decision was purely commercial and not related to their product’s safety.
Why Women File Essure Lawsuits
Victims of Essure claim Bayer failed to warn them and the company is guilty of negligence. Many women say their health problems were ignored, and they felt discriminated against by doctors and the FDA. For women injured by the device, turning to the legal system may be the only way to receive compensation for medical bills and lost quality of life.
Many people file lawsuits because they want to prevent this product from harming others. One of those women is Kim Myers.
Myers told BBC News that she was pressured by her doctor to get the device. After the procedure, she suffered severe pelvic pain for three years before getting a hysterectomy to remove the metal coils. The pain put stress on her marriage and stopped her from doing many things she enjoyed, like riding horses.
“I have never in my life felt discriminated against like I have with this whole thing with Essure,” Myers told BBC. “[When I complained, my doctor] told me, ‘You’re a silly little woman, you’re hormonal.’ That’s the furthest thing from the truth.”
Allegations against Bayer:
- Failing to report and actively concealing adverse events of Essure
- Manufacturing Essure for three years without a license
- Failing to have a complete risk analysis for Essure
- Failing to track Essure
- Failing to disclose 16,047 medical device complaints of suspected device malfunction to the FDA
- Not reporting incidents of bowel perforation, broken coils and Essure migrating out of fallopian tubes
- Handing out Essure equipment to unqualified physicians to sell its product
- Negligently distributing Essure and compelling physicians to “sell” Essure to patients
- Improperly training doctors on how to use Essure
Preemption Laws and the Legal Battle against Bayer
Despite the number of complaints pouring in, preemption laws protect Bayer from Essure lawsuits. The law bars people from filing lawsuits against medical device makers with preemption status because the FDA supposedly puts the device through a rigorous process before approval. This ignited a battle against Bayer on social media.
The controversy caught the eye of consumer rights activist Erin Brockovich who says she is passionate about overturning the law and fighting for justice for the women affected by Essure.
“We need to hold companies accountable and in this situation Bayer can’t just turn their head and go ‘these 8,000 women don’t matter.’ I think that they have a responsibility, a duty, to take a look and, if there’s a question, pull it,” Brockovich told BBC. “One’s too many. Eight thousand women? You cannot disregard that voice collectively. There is something wrong with the product.”
"Bayer can’t just turn their head and go ‘these 8,000 women don’t matter.’"
- Erin Brockovich, consumer rights activist
Lawsuits against Bayer say the company lied to the FDA in its premarket application. The lawsuits that allege Conceptus violated the terms of the FDA’s premarket approval and committed fraud by withholding data from the agency. This could mean the company forfeited its protection under the preemption laws.
To help raise awareness about preemption and the dangers of Essure, a group of Essure victims banded together and formed the Facebook support group, Essure Problems. At one time, there were over 30,000 members — many of whom filed lawsuits against Bayer.
Members of Essure Problems routinely make trips to Washington to advocate for legislation to overturn the preemption laws and make medical devices safer.
Essure Lawsuit Status
Despite preemption laws, judges have been allowing lawsuits to proceed, and thousands of Essure lawsuits are pending against Bayer.
In April 2016, Judge John R. Padova of the Eastern District of Pennsylvania allowed five claims against Bayer to continue with the following allegations: Negligent manufacture, negligent risk management, breach of express warranty, negligent training and fraudulent manufacture.
Meanwhile, Bayer denies any wrongdoing.
“We have sound defenses including federal preemption. The design, manufacturing method, warnings and instructions for use for Essure were approved by FDA under the agency’s pre-market approval (PMA) authority, which subjected Essure to the highest level of scrutiny that exists in the federal regulatory system,” Tara DiFlumeri, a Bayer spokesperson, told Mass Device about the Pennsylvania lawsuits. “This complaint is an attempt by plaintiffs to 2nd-guess the FDA.”
In August 2016, a California state court in Alameda County cleared the way for more Essure lawsuits. County Judge Winifred Smith’s Aug. 2 ruling allowed 14 women’s claims to proceed, Reuters reported. Smith denied Bayer’s three motions to have the cases thrown out.
So far, Essure litigation continues with individual lawsuits in various state courts.
Essure Complications Mentioned in Lawsuits
Thousands of others claim Essure caused them severe trauma, and Bayer failed to inform them of the risk. Many women who filed lawsuits did so to draw attention to the problem and prevent other women from suffering the same health problems.
The list of complications in lawsuits includes:
- Abdominal pain
- Heavy periods
- Autoimmune disorders
- Device breakage
- Device displacement
- Weight fluctuations
- Severe pelvic pain
- Allergies to nickel
Lawsuits say Bayer “conspired to engage in…misconduct…for the purpose of enriching themselves and creating an injustice at the expense of plaintiffs” and their health. Some women lost marriages, family and even died after complications.
For many women, the Essure experience has been long and arduous. They incurred medical bills, scheduled multiple surgeries and suffered poor health for years before they filed lawsuits.
Tanya de la Paz
Tanya De La Paz filed her lawsuit against Bayer in September 2015. According to the lawsuit, in July 2012, De La Paz had her first Essure procedure. However, one of her fallopian tubes perforated during the procedure. She went to a hospital because of the bleeding. She returned in September 2012 for a second procedure. The doctor implanted the metal coils successfully, but she suffered constant daily pain. When she returned to her doctor three months later for a follow up, the examination revealed that coil in her right fallopian tube was broken.
Bayer advised De La Paz’s physician to surgically remove the right fallopian tube and the broken coil. The left coil remained implanted and continued to cause her constant daily pain and heavy bleeding. She also suffered weight gain, stomach issues and mental and emotional anguish. She scheduled surgery to remove the second metal coil in September 2015.
According to her lawsuit, “[Bayer] actively and fraudulently concealed adverse reports of migrations and perforations from the Plaintiff and from the FDA.”
Heather Walsh filed suit against Bayer in 2013. In 2008, she went to her doctor’s office to have Essure implanted, according to her lawsuit. The doctor told her that a representative from Bayer would be there to supervise the procedure. The rep never showed, and the doctor attempted to implant the coils. The procedure failed. Walsh was forced to come back the following month and the doctor again tried several times to implant the coils without the presence of the Bayer rep. Finally, after several attempts, the inserts made it into the fallopian tubes.
After two years and four hospitalizations for severe pain, fainting and fever, she underwent a CT scan. It revealed one of the Essure coils had lodged behind her colon. There were three micro inserts and not two, as there should have been. She had to undergo a hysterectomy and an additional surgery to remove the coil in her colon. Now, she is left with a legacy of pain and autoimmune disorders. She said Bayer failed to warn her or train physicians properly.
“Defendant’s conduct was malicious, intentional, and outrageous, and constitutes a willful and wanton disregard for the rights and safety of Plaintiff and others,” Walsh’s lawsuit alleges.
Stephanie Bailey’s husband, Bradley, filed a lawsuit on her behalf. After Stephanie received Essure in November 2010 she suffered numbness in her extremities, long-lasting migraines, joint pain and severe pelvic pain. She had to have a hysterectomy to remove Essure and subsequently died.
Her husband is seeking damages for loss of love, comfort, care, companionship, affection as well as emergency care, funeral expenses and medical bills.
Michelle Garcia had Essure implanted in April 2011 and again in May 2011. She suffered memory loss, numbness, severe pelvic pain, extreme menstrual changes and severe headaches. In order to remove Essure she had a bilateral salpingectomy.
Her lawsuit says Bayer, “actively and fraudulently concealed adverse reports of migrations and perforations from this Plaintiff but also from the FDA.”
Michelle Y. Llamas is a senior content writer. She is also the host of Drugwatch Podcast where she interviews medical experts as well as patients affected by drugs and medical devices. She has written medical and legal content for several years — including an article in The Journal of Palliative Medicine and an academic book review for Nova Science Publishers. With Drugwatch, she has developed relationships with legal and medical professionals as well as with several patients and support groups. Prior to writing for Drugwatch, she spent several years as a legal assistant for a personal injury law firm in Orlando. She obtained her English – Technical Communication degree from the University of Central Florida. She is a committee member with the American Medical Writers Association.