Essure Birth Control LawsuitBaum Hedlund2018-12-05T11:42:12-08:00
Essure Birth Control Lawsuit
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The Essure birth control device is a coil made of metal and plastic that is inserted into the Fallopian tubes. The coil causes the body to produce fibrous tissue that blocks the tubes within about three months, preventing fertilization of the eggs.
Over the past several years, thousands of women have come forward with stories of nightmarish suffering endured following implantation of the Essure device. More than 16,000 have now filed an Essure birth control lawsuit and on July 20, 2018, the current owner of the device, German pharmaceutical giant Bayer, announced it will discontinue Essure sales in the U.S. by the end of the year. Sales outside the U.S. were halted last year.
Essure was originally developed by Conceptus, Inc., a medical device manufacturer based in Mountain View, CA. (Bayer purchased Conceptus in 2013 for $1.1 billion.) The device was designed to replace tubal ligation, a surgical procedure in which the Fallopian tubes are cut and tied off, with the patient under general anesthesia. Tubal ligation is still the most common sterilization operation.
The U.S. Food and Drug Administration approved Essure in 2002, to be used by women who desired “permanent birth control (female sterilization),” and under the condition that professional labeling would state, “The Essure System should be considered irreversible.” When it approved Essure, the FDA warned, “The risks of long term implantation are unknown.”
Despite the unknown risks (for an irreversible procedure) the agency’s Center for Devices and Radiological Health (CDRH) concluded that Essure was “safe and effective for permanent birth control.”
Over time it has become increasingly clear that the CDRH’s conclusion was substantially wrong. Since its release, Essure complications have included:
More than 29,000 adverse event reports submitted to the U.S. Food and Drug Administration
An additional 16,047 Essure complaints that Bayer never submitted to the FDA
A 2013 FDA patient label update to include “risks of chronic pain and device migration.”
A 2016 FDA order requiring a “black box” warning placed on the Essure label
Suspension of Essure sales in Europe and a recall of the devices by some European Union member states.
“Fibrotic response” is fibrosis, the formation of connective tissue containing long fibers that takes place when the body repairs damage. Scar tissue is the result of fibrosis. When Essure is inserted, fibrous tissue grows into and around the Essure coil, filling the Fallopian tube and blocking it, so that sperm cannot reach the eggs.
A fibrotic response also underlies many diseases, such as pulmonary fibrosis and cirrhosis of the liver. Chronic inflammation can trigger a host of diseases, including heart attacks, colon cancer, rheumatoid arthritis, (which develops into pulmonary fibrosis in 15-30% of cases), and atherosclerosis (hardening of the arteries caused by inflammation and fibrosis).
Chronic inflammation is also a common symptom of autoimmune disorders, which are frequently diagnosed in Essure victims.
PET fibers are another possible source of Essure problems. PET is a controversial plastic used in making water bottles. Toxic chemicals acetaldehyde and antimony are known to leach from water bottles. Small amounts of antimony can cause headaches, dizziness and depression—all adverse Essure side effects reported by patients. According to one doctor, polyethylene terephthalate could pose serious health risks to Essure birth control users.
In a recent CBS News report on the Essure device, an Illinois doctor said, “The coils are made of nickel and polyester [PET is a type of polyester] fibers. And when they’re placed in the tube, it creates an inflammation reaction… But this inflammation reaction continues in the body.”
Experts Criticize Essure Testing and Research
Several experts have questioned the adequacy of the research that formed the basis for approval of the Essure implant.
In 2015, doctors at the Yale University School of Medicine and Yale University School of Public Health, writing in the prestigious New England Journal of Medicine, discussed numerous fundamental deficiencies in the two studies that formed the basis of premarket approval for Essure contraception. “Given the limitations of the relevant studies,” they wrote, “it’s not surprising that so many years passed before safety issues with Essure were recognized.”
In 2016, Obstetrics and Gynecology published a commentary on the FDA approval process for medical devices by researchers at Northwestern University’s Feinberg School of Medicine and the University of Chicago Medical Center. After analyzing device approvals from 2000 to 2015, the doctors concluded, “Our results reveal significant weaknesses in the preapproval and postapproval regulation of high-risk obstetrics and gynecology devices.” The FDA Essure approval, they wrote, was based on “insufficient long-term evidence and postmarket surveillance requirements.”
On September 24, 2015, the Obstetrics and Gynecology Devices Panel of the FDA’s Medical Devices Advisory Committee met to review the premarket testing of the Essure procedure and hear testimony from victims. Several panel members were keenly interested in whether the makers of the Essure had investigated possible toxic reactions to the nickel and polyethylene terephthalate in the device. A transcript of the hearing reveals that the answers they received were not reassuring.
Panel member Dr. Peter Schalock, an expert in metal hypersensitivity from Harvard Medical School and Massachusetts General Hospital, wanted to know why there was no “data on nickel allergy when we have a device that’s 55% nickel, and 20% of women — approximate numbers — are known to be nickel allergic? Why is there no data? How can you put this in your package insert and then have no clue?”
Richard Chappell, a professor of biostatistics and medical informatics at the University of Wisconsin was concerned about antimony leaching from the PET and having “constant contact with an internal organ.” He asked to see evidence of antimony leaching in patients, easily available, he noted, from relatively cheap blood testing. Benjamin Fisher, an FDA representative, answered that information on antimony was not provided for Essure during premarket approval. Bayer gave no response.
Dr. Chappell also observed that the reason they were meeting, 13 years after the FDA approved Essure, was due to the weakness of premarket testing (neither randomized nor controlled). He urged the FDA to adopt randomized clinical trials as the standard for approving medical devices like Essure.
Sarah Sorcher, a researcher with Public Citizen’s Health Research Group, also testified at the hearing. She questioned whether pain as a side effect was accurately reported during Essure testing, and then compared the actual pain experienced by one woman who participated in early testing with how that pain was reported to the FDA by the device maker. Though the woman experienced “long-term debilitating pain” that began soon after the Essure procedure, her comfort and satisfaction with the device were reported to be “uniformly high,” with ratings of “excellent and very satisfied.” Several others testified about irregularities in the reporting of clinical trial outcomes during testing for Essure side effects.
As a result of the hearing, the FDA ordered Bayer in February 2016 to conduct a new post-marketing safety study of Essure in real world environments, this time with a control group of women receiving tubal ligation surgery. Bayer was given until 2020 to enroll 2,800 women for the study—1,400 to receive Essure, 1,400 in the control group. The study was to be completed by 2023. As of October 19, 2017—1 year, 8 months after the FDA order—Bayer had only enrolled 136 women.
Three weeks after implanting, I experienced heart palpitations, weight gain, hot flashes, migraines, insulin resistance, nickel and chemical allergies, psoriasis of my hands and my vagina, interstitial cystitis, and 37 other symptoms. Soon I became so tired I was sleeping 18 hours a day. My neurological team was stumped. I had all the symptoms of narcolepsy. I even tested positive for the narcolepsy genotype but never once tested positive for narcolepsy in multiple sleep studies. Their last words to me were go home, get a good night’s sleep, and see a psychiatrist.
Severe, chronic pain (pelvic, abdominal and joint)
Hives and rashes
Abnormal weight gain
Cognitive impairment (“brain fog”)
Nausea and vomiting
Many of these and other Essure problems are common symptoms of autoimmune disorders.
In addition to these side effects, there are numerous cases of serious physical injuries:
Perforation of the Fallopian tubes
Perforation of the uterus
Migration of the device into the peritoneal cavity
Perhaps the most striking adverse effect of Essure implantation was revealed in the November 2015 issue of the medical journal BMJ (originally the British Medical Journal). The journal published a study by four doctors at Cornell University’s Weill Medical College that compared the Essure sterilization procedure with the other most common surgery for sterilization: tubal ligation. In tubal ligation, the Fallopian tubes are surgically cut and tied off with the patient under general anesthesia. The doctors gathered data on thousands of patients who underwent the Essure procedure or tubal ligation in New York State between 2005 and 2013. They compared outcomes between 8,048 women who were implanted with the Essure device and 44,278 patients who received tubal ligation.
Since implantation of the Essure permanent birth control device does not require either the general anesthesia or abdominal incision used in tubal ligation, it is considered to be the less invasive procedure. The Cornell researchers, however, found that one year after surgery, women implanted with the Essure were 10 times more likely to need additional surgery (“reoperation”). After two years, they were eight times more likely to undergo a reoperation and even at three years they were still six times more likely to need reoperation. The doctors noted that “most of the adverse events reported by patients for the Essure based procedure were injuries that would require a reoperation.” Surprisingly, general anesthesia was still used in half of the Essure implantations.
One reoperation that is shockingly common following Essure implantation is the hysterectomy. Earlier this year, Madris Tomes, a data analyst and founder of the health research group Device Events, presented statistics on Essure-associated hysterectomies to the FDA, data taken from the FDA’s own records. According to Tomes, who formerly worked for the FDA, more than 18,000 women have reported having hysterectomies due to Essure complications.
Women Speak Out Against Essure Birth Control
The only way to truly reveal the horrendous suffering of the women who have been injured by Essure birth control side effects is to listen to their own stories. One instantly understands why so many have filed an Essure lawsuit.
Many of the stories are found in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, where over 29,000 adverse reaction reports tied to Essure have been filed—nearly 12,000 in 2017. In all likelihood, the situation is worse than these figures indicate. Many consumers are unaware of the FDA reporting system and manufacturers often do not report or misreport adverse reactions. An FDA inspector who reviewed Conceptus documents between December 2010 and January 2011, found reports sent by health professionals of perforation of the bowels and movement of the Essure device into patients’ abdominal cavities. The reports were never sent to the FDA.
Reports in the MAUDE database are not minor. Manufacturers are only required to submit them if one of their devices “may have caused or contributed to a death or serious injury or has malfunctioned and the malfunction of the device or a similar device that they market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.”
The following MAUDE report was submitted by one woman who had the Essure insertion procedure:
Within months of my Essure implant I began constant vomiting to the point of removing my gallbladder, which did not help, constant hot flashed, constant cramping and sharp pains, diagnosed with fibromyalgia, anxiety, and PTSD to the point of being admitted to a neurological center. I wake every morning with “morning sickness” and constant pains throughout my entire body, my joints and muscles …. Within a week after my implants I got my very first ever migraine; the migraines have gotten so frequent I find myself battling them weekly sometimes lasting two or three days.
FDA report filed by Essure victim.
Essure Recall Timeline
November 4, 2002
FDA approves Essure.
Warning that women hypersensitive or allergic to nickel should not undergo
Essure implantation removed from information provided to patients and physicians.
Essure label updated to warn patients of chronic pain and device migration.
September 24, 2015
Obstetrics and Gynecology Devices Panel of the FDA’s Medical Devices
Advisory Committee meets to discuss Essure problems, hear testimony from victims.
February 29, 2016
FDA orders black box warning placed on Essure label, orders
Bayer to conduct post-marketing study.
February 20, 2017
Brazil halts sales of Essure.
August 3, 2017
European Union (EU) suspends license to sell Essure in the EU for 3 months.
August 30, 2017
Australia recalls Essure device.
September 18, 2017
Bayer announces end of non-U.S. sales of Essure.
April 9, 2018
FDA restricts sales of Essure to women who have read and signed brochure on device risks.
July 20, 2018
Bayer announces it will discontinue Essure sales.
Filing an Essure Birth Control Lawsuit
A principal of federal law presents a legal roadblock to filing an Essure lawsuit, but recent court decisions have removed that barrier for many. The Essure device is classified by the FDA as a Class III device. Class III devices are devices that potentially pose a high risk of illness or injury and for this reason they are required by the FDA to undergo a more demanding approval process referred to as a PMA (premarket approval) process.
But a legal concept known as federal preemption protects medical devices approved under the PMA process. Federal preemption essentially means that where federal and state laws are in conflict, federal law prevails. Since the FDA is a federal agency, medical devices that have undergone the FDA’s most rigorous PMA approval process are considered protected from medical device lawsuits brought at the state level and based upon state laws, unless those laws match the FDA’s federal restrictions.
Recently however, a judge in the Superior Court of California, Alameda County, rejected arguments by Bayer that 11 Essure lawsuits in that state should be dismissed under federal preemption. A judge in Pennsylvania is also permitting Essure lawsuits in that state to go forward on a more limited basis.
The grave injuries suffered by women who received the Essure implant demand that their lawsuits be heard. That may not happen in all states, but in at least some it will.