Essure Permanent Birth Control Device Tied to Mounting Injury Reports, Law Suits; FDA Mandates Revised Labeling, Guidance, MonitoringEssure is a permanent method of birth control that has been tied to serious adverse reactions since its launch. Early on, the adverse reactions caught the attention of well-known consumer advocate, Erin Brockovich, who sought to have Essure banned when she learned that women were suffering significant adverse reactions tied to the sterilization procedure.
Our firm is investigating potential lawsuits on behalf of individuals who have been injured, or died, due to alleged Essure birth control side effects.
What is Essure?
According to the Mayo Clinic, the Essure system is a permanent method of birth control for women. The Essure device is composed of an expandable nickel-titanium coil with a stainless coil within it the expandable coil. The coils are placed in the fallopian tubes through a catheter via the vagina; an incision is not needed and the procedure may be completed in a doctor’s office. Scar tissue forms around the coils, which is meant to block the fallopian tubes and stop sperm from reaching the egg, causing permanent fertilization prevention.
For the first few months following insertion, another form of birth control must be used until occlusion has been confirmed. The procedure must also be followed up with an hysterosalpingography X-ray, which confirms that the fallopian tubes are blocked. According to a September 2015 MedPage Today report, the FDA approved transvaginal ultrasound as an alternative test to confirm proper placement of the Essure.
The Essure procedure, noted the Mayo Clinic, does not protect against sexually transmitted diseases, is not reversible, and does not impact menstruation. Some patients are poor candidates for the Essure. Also, some procedures may not be performed following implantation, such as some pelvic electrosurgical procedures, due to Essure inserts’ metallic components.
The Essure procedure, which is marketed by Bayer, received pre-market clearance by the U.S. Food and Drug Administration (FDA) in 2002. Conceptus, Inc., Essure’s original designer and maker indicated that more than 700,000 women have undergone the permanent Essure procedure. To date, according to Bayer, approximately 750,000 units of Essure have been sold.
Conceptus, Inc. was acquired by Bayer AG in 2013. Bayer indicated in a statement that it “has been in regular communication with the FDA about the risk-benefit profile of Essure and the informational needs of both healthcare providers and patients,” according to The Wall Street Journal.
New Study Reveals Increased Essure Risks
NBC News reports that, as of October 2015, an emerging study may confirm what some women have been saying about Essure. Researchers discovered that women implanted with the Essure device underwent 10 times as many operations to correct problems allegedly associated with the device when compared to women who underwent traditional surgery to their fallopian tubes for the purpose of preventing pregnancy.
Dr. Art Sedrakyan of Weill Cornell Medicine in New York and colleagues reviewed data from 2005 through 2013 in New York involving 8,048 women who received Essure implants. comparing these women to 44,278 women who underwent standard surgery to block or “tie” their fallopian tubes. The team discovered that women who chose Essure often had to undergo surgery, despite that Essure is touted as a nonsurgical method of permanent birth control, according to NBC News. In fact, the risk of a second procedure was 10 times greater in women implanted with Essure when compared to women who underwent laparoscopy. The study appears in the online version of the British Medical Journal.
“A more than 10-fold higher occurrence of reoperation during the first year following Essure-based surgery is a serious safety concern,” the team wrote in their report. “Essure helped them avoid surgery in some instances, but they are still facing a 10-fold high risk of getting that surgery done,” Dr. Sedrakyan told NBC News. “And that translates to one in 49 or 50 women getting this surgery again,” he added. “And that surgery is likely to be much more complicated than the laparoscopic approach that they should be considering.”
Dr. Sedrakyan’s team noted that women implanted with Essure were likelier to be over the age of 40; however, Bayer indicates that the safety of Essure in women over 45 is not known and does warn that side effects include pain and risk that the Essure spring may break. The team did not discover an increased risk of pregnancy, but did discover that, while Essure is meant to be placed without use of general anesthesia, about half of the women who were implanted with Essure were put under general anesthesia to receive device implantation.
The FDA indicated that it is not considering pulling the device from the market, but indicated that it will determine if additional warnings should be added to the device’s labeling. “This is a high priority issue for the agency,” the FDA wrote in a statement. “The FDA plans to review the findings of this study, along with the latest medical literature on the Essure device and input from panel members and the public during our recent advisory committee meeting, to determine what future actions may be appropriate.”
“In rare cases, part of an Essure insert may puncture the fallopian tube. Surgery may be necessary to repair the puncture,” Bayer indicates on its website. Dr. Sedrakyan says the risks “add up,” according to NBC News. “There are over 750,000 procedures done, so far most of them in United States,” he said. “So we believe this is commonly done procedure, and even small risk matters on a population level.” Speaking about women considering an Essure procedure, Dr. Serakyan said, “I hope that they will weigh the risks and harms in our study, talk to their clinicians about their specific conditions,” according to NBC News. “I also encourage them to get tested, and insist on getting tested for metal allergies and nickel allergies, and that is not done routinely right now and that could be important.”
Results of FDA Panel on Ensure: Mounting Injury Reports Prompt FDA to Convene Health Panel to Review Bayer’s Essure
Federal regulators indicated that a panel of health experts was scheduled to convene to review Bayer’s Essure to help determine if the device and procedure are safe. move followed mounting complaints over potential side effects, NBC News reported.
The FDA’s Obstetrics and Gynecology Devices Panel met on September 24, 2015 and included a public advisory meeting to discuss Essure and gather feedback from presenters, panel members, and the public “to inform recommendations and next steps about Essure.” The FDA indicated it would also consider evidence for complications associated with Essure that occur more than five years after placement.
The meeting was intended to discuss whether changes should be made to the Essure label and if additional research is needed to assess Essure device and procedure risks. According to National Public Radio (NPR), expert opinions would be sought on the risks and benefits of the Essure System, public comments would be sought from women implanted with the device, and a review of recent and available data on the Essure System’s safety and efficacy would be conducted. The panel will also scheduled to review adverse events reports and injuries related to implant perforation and migration, device removal, chronic pain, allergic reactions, and unintended pregnancy. The committee would also be asked to provide recommendations on proper device use and labeling and the need for additional post-market clinical studies, according to NPR.
Meanwhile, the FDA previously updated Essure’s short-and long-term risks on its website and the drug’s adverse events reported through May, NPR reported.
According to the FDA’s Obstetrics and Gynecology advisory committee, Essure packaging should clearly state that the Essure is a surgical device and the device should include more inclusive and complete instructions for insertion and follow-up monitoring. MedPage Today indicated that the discussion-which covered topics including “post-marketing data, peer-reviewed studies, and hours of patient comments about the Essure device”-went “longer than usual” and included “suggestions for best practices, stronger patient education, and increased collection of data, such as:
- Put into place an inter-operative imaging protocol to ensure the Essure is correctly placed.
- Create practitioner guidance to more quickly ensure identification of potential long-term complications.
- Support early intervention analysis should abnormal bleeding occur following Essure implantation.
- Mandate a checklist or signed informed consent form to ensure clinicians discuss Essure risks, benefits, and alternatives with patients.
- Develop a patient registry to track pregnancy and adverse event rates associated with Essure.
- Strengthen training programs for Essure implantation and placement.
- Develop Essure device removal training.
- Change current labeling that indicates the Essure procedure is “nonsurgical” to language that indicates the Essure is an implantable “surgical” device.
- Strengthen guidelines to enable clinicians to “give up” when a procedure becomes very challenging; for example, when the Essure does not move forward easily or when visualization of the device is not clear.
Also, according to panel findings, citing the FDA, an “unusually large proportion” of the estimated 5,093 medical device reports filed with the FDA as of June 1, 2015 were submitted voluntarily by patients and not the device maker, wrote MedPage Today.
Cheryl Iglesia, MD, temporary committee chair and surgeon at MedStar Washington Hospital Center, summarized the panel’s consensus that Essure was appropriate for patients seeking permanent contraception and who had also engaged in a thorough discussion of Essure’s advantages and potential harms, according to MedPage Today. While favorable patient candidates may include women at high risk for undergoing general anesthesia or laparoscopy, women who may be obese, or women for whom other reversible forms of contraception have failed, women who are diagnosed with chronic pelvic pain, auto-immune disorders, hypersensitivity to nickel or other metals, pelvic inflammatory diseases (PIDs), or with a history of abnormal uterine bleeding, may not be well-suited to this device, Dr. Iglesia noted.
Committee consumer representative, Cynthia Chauhan, MSW, received support for her suggestion to mitigate risk by being prepared for potential negative outcomes. “If you do not have access to someone who can remove [the insert] successfully you should not be implanting [it],” she said.
The committee supported better monitoring and earlier removal of Essure when problems are identified and also supported, in addition to a patient registry, increased data collection, particularly concerning allergies to Essure’s components. Such collection may include tissue biopsies surrounding the device following removal, as well as animal studies.
While the idea of a randomized controlled trial was considered, that notion was rapidly dismissed by most panelists due to both the expense and that the trial would likely lack the statistical strength to detect the events the group sought, said Marsha Wills-Karp, PhD, of the Bloomberg School of Public Health at Johns Hopkins University in Baltimore. Richard Chappell, PhD, of the University of Wisconsin, pointed out another “practical issue,” noted WebPage Today. That of attempting to convince patients to join a trial developed to respond to questions concerning adverse events and efficacy. “I don’t think it would accrue,” he said. Dr. Chappell criticized the agency for approving Essure without initially mandating a randomized trial. “It was a mistake not to have done so.”
FDA September 2015 Panel on Ensure Hears from Advocates and Women Suffering Serious Reactions Following Essure Implantation
During the public portion of the panel discussion, more than 30 patients spoke, discussing symptoms that included:
- Severe abdominal pain
- Bleeding irregularities
- Painful sex
- Auto-immune disorders
- Extreme fatigue
- Perforation of the uterus
- Becoming pregnant after the Essure System had been implanted
One woman talked about how she was implanted with the Essure in 2011 and that, following implantation, she experienced “back pain, migraines, heavy painful periods, hair loss, chronic fatigue, and nickel sensitivity.” She told the panel that she became depressed and suicidal, saying that, “I felt like less of a woman, less of a human,” according to MedPage Today. Many women said they faced challenges trying to locate doctors who would be willing to remove the implanted Essure, but when they were able to have the device removed, most of their symptoms disappeared.
Sarah Sorscher JD, MPH, of the consumer group Public Citizen’s Health Research Group, told the committee, “A device that causes this level of long-term debilitating pain should not remain on the market.” While other patients and patient advocates, such as Diana Zuckerman, PHD, president of the National Center for Health Research, accused the sponsor of manipulating survey questions and re-writing patient-provided responses. “The question is, do you believe what the data are showing or do you believe what the women are telling us?” Zuckerman asked the committee.
Meanwhile, an FDA audit of random cases from a variety of sites concluded, “that there was not a pattern of discordant reporting,” according to an agency representative speaking at the meeting.
Some of the women stated that they were forced to undergo invasive surgeries to have the Essure device removed; women were provided three minutes each to speak to the panel and many shared personal experiences of adverse reactions.
One woman, who administrates the online group concerning adverse Essure reactions said she was 38-years-old when she received her Essure implant in 2013 to minimize what was described as “near constant menstrual cycle.” Permanent sterilization was suggested prior to the endometrial ablation procedure she was seeking to help treat excessive uterine bleeding. Her doctor recommended Essure. One week after the procedure, she said she returned to her physician due to severe pain. Her left fallopian tube was infected and had abscessed. Four weeks following implantation with the Essure System, she underwent a hysterectomy, and alleges the Essure has caused her significant problems that continue to persist. “My hope for [the meeting], and this probably was very optimistic, is that after hearing our stories, the FDA would’ve made the decision to pull it,” she told The Huffington Post. “You can’t ignore that many women standing there telling you stories,” another administrator of the online group said. This woman was implanted with the device in 2012. After 22 months of what she described as constant pain and bleeding, including a number of hospital emergency department visits, she underwent a hysterectomy. The site has more than 21,600 members 600 were added in the past week, according to The Huffington Post.
For its part, following the panel, Bayer indicated that the safety and efficacy of Essure is supported by more than a decade of science, adding, “There’s a need for safe and effective options for permanent birth control for women who have decided they’ve completed their families, and that’s what Essure can provide for appropriate patients. Bayer stands by the positive benefit-risk profile of Essure, and we look forward to working closely with the FDA as it considers the Panel’s advice,” said Dr. Dario Mirski, vice president and head of U.S. medical affairs at Bayer.
Women Have Long Complained of Alleged Essure Adverse Reactions
Prior to the September 2015 panel, controversy and adverse events were mounting. In fact, the Mayo Clinic website indicates that risks associated with the Essure procedure include infection, pelvic pain, perforation of the uterus or fallopian tubes, and tubal blockage occurring on one side.
Dr. Jennifer Ashton, senior health contributor for ABC News, who said she was trained in the Essure procedure in 2002, has opted against performing the Essure procedure on her patients. Instead, she says, she recommends other forms of permanent birth control with a better risk-benefit profile. “Whenever there is the permanent placement of a foreign body-in this case, metal coils-inside the body, there is the potential for chronic pain,” Dr. Ashton said. “Because Essure does not offer any known benefit towards risk reduction of ovarian cancer, as a tubal ligation does, I feel that other forms of permanent birth control are better and safer, including male vasectomy. Women considering permanent birth control should be offered all options, including tubal ligation and male vasectomy, not only the procedure that a woman’s doctor is able to perform personally,” she noted.
“We want to understand, as a company, what is going on,” said Dr. Patricia Carney, Medical Director for Essure. “We want to know whether there is a link to the product,” she added, according to NBC News.
Dr. Carney is not alone. Other health care practitioners welcome the discussion in the hopes that a better understanding of potential risks will be gained. In fact, Dr. Sebastiaan Veersema, a gynecologist at St. Antonius Hospital Nieuwegein in the Netherlands, has implanted the Essure in nearly 1,400 women. Dr. Veersema has also trained dozens of physicians on how to conduct the Essure implantation procedure. Dr. Veersema now says that more research is needed, according to NBC News. “If there is something wrong with the device I want to know,” he said, noting that a more stringent screening process may be needed to ensure that women diagnosed with fibroids and other uterine problems do not undergo the Essure procedure.
In one case, a woman told ABCNews.com in 2013 that she opted for the Essure based on manufacture claims of minimal downtime. She alleges to have suffered from severe cramping and was having difficulty moving. When she complained to a physician, the doctor shook an Essure coil in her face and told her that something so small would not cause that type of pain, she told ABCNews.com. She underwent a hysterectomy after learning that a so-called “misshape” in her fallopian tube caused the coil to eject into her uterine wall.
In 2015, NBC News reported on a woman who allegedly suffered significant adverse reactions following implantation with the Essure device. The woman indicated that she was implanted with the Essure when she was 28 years old after having three children. She believed her symptoms were hormonal and her body was adjusting to the Essure, describing loss of hair and teeth and pain throughout her body. She underwent removal of the device and a hysterectomy in 2012 and said that, after a few days following removal of device, “… it was like I woke up from a five-year flu,” according to NBC News. The woman opened a social media page concerning Essure injuries and, according to NBC, more than 17,000 women have joined and complained of issues, including chronic pain, heavy bleeding, fatigue, and skin allergies.
Another woman implanted with the Essure device in 2010 alleged to NPR that she suffered from a variety of issues, such as chronic fatigue; migraines; joint pain; digestive issues; back pain; heavy, clot-filled periods; difficulty concentrating; abdominal pain; hair loss; tooth deterioration; depression; and severe bloating. Other women have reported the same symptoms after being implanted with Essure, according to NPR.
In one case brought to the attention of Parker Waichman, a man advised that his partner is suffering from painful intercourse and that she is unable to have intercourse. She was implanted with the Essure device in 2009 and has become so distressed due to the pain that she has been nearly bed-bound since 2011.
FDA Reports of Essure Injuries According to the FDA, it received 5,093 reports of adverse events-including deaths-among women who were implanted with the Essure. In fact, since Essure’s approval in 2002, the agency has received reports of four deaths of women implanted with the device and five reports of the deaths of fetuses in women who became pregnant while implanted with Essure, according to The Wall Street Journal.
In a search conducted by the FDA of its MAUDE database (Manufacturer and User Facility Device Experience) from November 4, 2002 through May 31, 2015, the FDA discovered that the 5093 reports related to Essure most frequently cited problems, including:
- Pain/abdominal pain (3353)
- Heavier menses/menstrual irregularities (1408)
- Headache (1383)
- Fatigue (966)
- Weight fluctuations (936).
The agency indicated that most of the reports received involved multiple problems and that the most frequent involved patient-device incompatibility (941), including nickel allergy, migration of the device or a component (482), device operating differently than expected (301), device breakage (259), and malposition of the device (133).
Some women implanted with Essure devices have become pregnant. There have also been reports of the Essure migrating through the fallopian tubes, which requires surgery. Among the deaths reported, the FDA indicated that one death resulted from an infection following the implant procedure, one related to uterine perforation, one involved surgery to remove the device, and one involved a suicide. Women who become pregnant with the Essure in place are likelier to have an ectopic pregnancy, a sometimes life-threatening pregnancy in which the embryo implants outside the uterus.
FDA Mandates Clinical Study, Adds Boxed Warning to Essure
On February 29, 2016 the FDA announced actions it would take to address the risks associated with Essure. In a press release posted on the FDA website, the agency indicated that it ordered Bayer to conduct a clinical study evaluating real-world side effects and complications associated with Essure. Additionally, the FDA also indicated that it plans to require a boxed warning, the strongest type of FDA warning, on the device’s label, as well as a “Patient Decision Checklist” to inform patients about the benefits and risks of using Essure.
According to the FDA, some women may face serious complications with Essure, including:
- Persistent pain
- Perforation of the uterus or fallopian tubes due to device migration
- Abnormal bleeding
- Allergy or hypersensitivity reactions
The FDA plans to require a black box warning on Essure listing adverse events that have been reported, including insertion and removal procedures. In its draft guidance, the FDA proposed language for the “Patient Decision Checklist.” The goal of the checklist is to ensure that patients are fully aware of the benefits and risks of Essure so that patients are able to make informed decisions with their physicians. The checklist also highlights the importance of a “confirmation” test, which is to be conducted three months after Essure implantation to ensure that Essure has been properly placed
“The actions we are taking today will encourage important conversations between women and their doctors to help patients make more informed decisions about whether or not Essure is right for them,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health. “They also reflect our recognition that more rigorous research is needed to better understand if certain women are at heightened risk of complications.”
Bayer was ordered to conduct a postmarket surveillance study to evaluate the risks associated with Essure compared to laparoscopic tubal ligation. The study will review the rates of complications tied to Essure, such as unplanned pregnancy and pelvic pain, as well as how these events affect a patient’s quality of life. The findings of this study will influence future FDA actions regarding Essure.
Essure Lawsuits, Call for Recall
An April 2015 ABC15 news report indicated that it was advised by the FDA that the agency had responded to citizens’ requests seeking to remove Essure from the market. The consumer complaints were received by the agency and forwarded to its Office of Compliance.
A number of lawsuits have been brought against Bayer over the Essure, including at least one lawsuit brought in 2015 against Bayer Corp., Bayer Healthcare LLC; Bayer Essure, Inc.; Bayer Healthcare Pharmaceuticals, Inc.; and Bayer A.G. over allegations that the maker of the permanent birth control intentionally misled women implanted with the device and violated the conditions under which Bayer received premarket FDA approval.
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