Holly Kelly Ennis
Essure's Timeline Continues as New Developments Occur in 2018
What started out as an exciting new contraceptive device for women has morphed into a legal battleground and a grassroots social movement phenomena. Similar to the #metoo and #timesup movements, #EssureProblems has gained worldwide support and recognition and has grown to nearly 37,000 members as of July 3, 2018. These women have joined together to ensure that the controversial birth control is off the market world-wide and they are well on their way to accomplish this goal.
The Essure device is a four-centimeter coil placed into each fallopian tube to prevent pregnancy by causing severe inflammation creating a total blockage of the fallopian tubes. The coil contains nickel, which some women are unknowingly highly allergic. The coil also contains polyethylene (PET) fibers, which irritate and inflame the tubes, causing scar tissue to form over the coils, blocking subsequent fertilization. Unfortunately the PET fibers which create the irritation to form the scar tissue, often cause the body to fight what it deems to be an infection or foreign body, creating a host of other problems from autoimmune disorders, neurological problems, kidney, adrenal and thyroid disorders and even cancer. The coils often become dislodged, perforating the fallopian tubes, uterus, colon or other internal organs. The social movement which has led to today's controversy has been interesting to follow:
2002-Essure was approved by the FDA on November 4, 2002. The product was originally manufactured and marketed by Conceptus, however, Bayer acquired Conceptus on June 5, 2013.
2011-Angie Firmalino, frustrated by the injuries she suffered from the device creates the "Essure Problems" Facebook page.
2011-2015- Essure Adverse Event reports are quietly piling up within the FDA. Women are connecting the dots between their physical symptoms and injuries and the controversial device.
10/10/2013- Consumer Advocate Erin Brockovich enters the fight against Essure and begins working with the Essure Problems Group to have Essure removed from the market.
4/21/2014-A new Study published in the journal, Contraception, claims that women are more likely to become pregnant after being implanted with Essure than with traditional tubal ligation.
2/20/2015- A Citizen's Petition is filed with the FDA claiming the Essure PMA should be revoked as the expedited pre-market approval process was "replete with fraud", including the altering of clinical trial participants' medical records.
4/24/2015- The Five-year post market study required under the 2002 PMA approval is finally published.
6/24/2015- The FDA reports that it has received over 5,000 complaints regarding Essure and after much prompting by the Essure Problems Group, agrees to hold a public hearing on September 24, 2015 to evaluate the overall safety and effectiveness of Essure.
9/24/2015- The FDA held a day long hearing before a panel of experts who heard patient and expert testimony regarding the safety and efficacy of the Essure device. The panel criticized the manufacturer for not collecting enough data regarding the device and the manner in which the clinical trials were conducted. It concluded that more information was needed regarding the safety of the device, but did not recommend removing it from the market.
10/08/2015- A New England Journal of Medicine article sharply criticized the clinical trials and pre-market studies regarding the Essure device, noting that, "Although Essure is designed to remain in place for a woman's lifetime, few women in the premarketing studies were followed for more than 1 year — a limitation that precludes conclusions about longer-term risks."
10/13/2015- A British Medical Journal Study reports that women implanted with Essure were 10 times more likely to require post-procedure surgery than women who underwent laparoscopic sterilization, noting that 2.4% of Essure patients required follow-up surgery one year after the initial procedure.
11/04/2015- Congressman Mike Fitzpatrick (R-PA) introduces the E-Free Act, which would require the FDA to remove Essure from the market no longer than 60 days after the bill is passed.
2016-Lawsuits are filled against Bayer regarding Essure in several states including Pennsylvania, California, Missouri, Illinois and New Mexico.
2/29/2016- The FDA orders Bayer to conduct another post-market study regarding the risks and benefits of Essure and will require a "black box" warning to be implemented as well as a patient decision checklist to be signed by doctors and patients before the device is to be implemented. However, the checklist is a "guidance" and the FDA has no method for enforcement by physicians.
6/08/2016- Congressman Mike Fitzpatrick and Representative Louise Slaughter (D-NY) introduce "Ariel Grace's Law" which would amend the law to allow patients harmed by Class III medical devices to more easily seek compensation for damages caused by the device.
6/30/2016- Health Canada issues warnings regarding the risks of serious complications from Essure and will be actively monitoring women implanted with the device. Health Canada is working with Bayer to create a black box warning and a patient decision checklist, which is intended to be reviewed and signed by the patient prior to be implanted.
11/15/2016-Essure 'black box' warning and patient decision checklist become effective and physicians are sent a 'Dear Doctor' letter regarding both.
2/17/2017- Brazil's health agency announces that Essure sales would be discontinued.
5/6/2017-Essure Problems Group holds national rallies in cities across America, demanding Essure be pulled from the market worldwide. A major rally occurred at the ACOG convention in San Diego.
6/19/2017- Bayer announces it will gradually cease sales of Essure throughout Canada due to a decrease in demand.
6/25/2017-Claiming decreased demand and sales, Bayer announces it will cease selling Essure in Finland and the Netherlands.
8/02/2017- The Patient-Centered Outcomes Research Institute (PCORI) board approves a "Real World Effectiveness and Safety" study of Essure vs. laparoscopic sterilization. This purports to be a non-biased study involving the two sterilization procedures.
8/03/2017- Ireland's National Standard of Authority decides against renewing Essure's commercial license, effectively suspending Essure throughout the European Union for 3 months.
8/30/2017- The Australian Medical and Science Ltd. (AMSL) issues a "hazard alert" for Essure and recalled all unused stock while also pulling the device from the market.
9/01/2017- Bayer announces that Essure will no longer be sold anywhere in the United Kingdom.
9/02/2017- The FDA approves Bayer's updated post-market surveillance study regarding Essure. The study will examine two groups of 1,400 women between the ages of 21 and 45 who undergo either laparoscopic tubal sterilization or the Essure device. The final study is scheduled to be released in 2023. Meanwhile Essure remains on the market and women continue to be implanted with the device during the pendency of the study.
9/18/2017-Bayer announces it it will stop selling Essure throughout the world with the exception of the United States, where it will remain on the marketplace.
9/25/2017- The Essure Problems group held a rally in support of the Medical Device Safety Act 2017. The group transitioned to a well-attended press conference presented by several of the co-sponsors of MDSA 2017. It is a bi-partisan bill currently co-sponsored by Brian Fitzpatrick, Rosa DeLauro, Louise Slaughter, and Jan Schakowsky. The bill would amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting all Class III devices, and will restore a patient’s right to litigation should he/she be harmed by a Class III medical device.
10/25/2017-Bayer releases it 3rd. Quarter Report which announces that there have been 10,600 Essure lawsuits filed against Bayer in the United States.
12/07/2017- Congresswomen Rosa DeLauro, Louise Slaughter and Jan Schakowsky meet with FDA Commissioner Scott Gottlieb and other FDA officials. However, Essure Problems Group representatives are disinvited. The FDA claims it would be a conflict of interests to meet with the Congresswomen and members of the public effected by the device, stating there was, "a long-standing FDA policy that constituents cannot meet with Representatives at the same time."
12/12/2017- Congressman, Peter DeFazio (D-OR) co-sponsors the Medical Device Safety Act 2017.
1/2018-French Study is released showing women undergoing sterilization with Essure are more likely to have a reoperation than with a traditional tubal ligation and also more likely to have an allergic reaction. The study reignites the long-standing debate on Essure's safety.
2/7/2018- Essure Problems Group Administrators, along with attorney, Holly Ennis and medical data specialist Madris Tomes from Device Events, meet with Commissioner Gottlieb at the FDA offices requesting that Essure’s PMA be suspended and the product removed from the market, pending the outcome of the current clinical trials, which will not be completed until 2023 and to discuss the completely ineffective Black Box Warning and Patient Decision Checklist.
4/9/2018- FDA issues an order restricting the sale and distribution of the Essure device to ensure that all women contemplating use of the sterilization device are provided with adequate risk information concerning the potential dangers of the device. The new Essure labeling, which will now be legally required, restricts the sale and distribution of the device to only health care providers and facilites who provide the mandated information to patients about the risk and benefits of the device, "in the form and manner specified in approved labeling." This information must be signed by both the patient and the physician, and Bayer is required to ensure provider compliance. The FDA will enforce these requirements and will take appropriate actions, including civil and criminal penalties if necessary.
4/21/2018- Essure Problems Administrators and attorney Holly Ennis attend the Tribeca premiere of The Bleeding Edge, a powerful and impactful documentary by Kirby Dick, Amy Ziering and Amy Herdy. The documentary exposes the lax approval process of medical devices in an industry where profits are prioritized over patients and exposes the medical device industry and the complicit FDA.
5/3/2018-Bayer's Quarterly Report reflects more than 16,800 lawsuits have been filed against Bayer for Essure related injuries as of 4/13/2018.
7/1/2018-Effective July 1, 2018, Connecticut's Department of Social Services will no longer be covering sterilization with the Essure device under the Healthcare Common Procedure Coding System (HCPCS). It is anticipated that other states across the country will follow Connecticut's progressive lead and refuse to cover the costs of implanting the controversial sterilization device.
7/1/2018- Spain's Essure Activist Group, The Free Platform of Essure - held a large protest in front of the Ministry of Health with hundreds of affected people from all over Spain. The protest against Bayer demanded greater protection and attention from the Spanish public health system for the removal of the Essure device from affected women. Essure is no longer sold in Spain.
7/3/2018- There are currently nearly 17,000 lawsuits filed against Bayer for Essure related injuries and approximately 29,000 adverse event reports filed with the FDA for Essure-related complaints. Bayer still steadfastly refuses to recall Essure from the market in the United States.
7/20/2018- Bayer announces that effective 12/31/2018 it will no longer sell the Essure device in the United States due to "declining sales and commercial reasons."
7/27/2018- The Netflix documentary, The Bleeding Edge is released worldwide.
7/2020- The PCORI study is expected to be completed and the results released
9/1/2023- The 5 year post-market surveillance study involving Essure and laparoscopic tubal ligation final report is due from Bayer.
Many events have transpired in the nearly 16 years since Essure entered the marketplace, but the most important battles still lie ahead. It is imperative that the FDA revoke the PMA granted for Essure, at least pending the outcome of the current post-market study, so innocent women do not continue to be implanted. Equally important is that the current litigation proceed swiftly and judiciously and provide the thousands of ladies grievously harmed with the compensation they deserve. Women who have not retained counsel are strongly urged to do so as time for filing a claim may be quickly expiring. Just as in the #metoo and #timesup campaigns, women need to continue to fight until Essure is off the market. #Essureproblems must continue to let their voices be heard.
Ennis & Ennis, P.A. has been representing women injured by Essure since 2015. If you or a loved one has been injured by Essure, contact attorney Holly Ennis at Holly@EnnisLaw.com, at 1-800-856-6405 or visit online at www.EnnisLaw.com for a free confidential consultation.