Essure Birth Control Lawsuit
If you or someone you know has been affected by this birth control device, please call the Essure Lawyers at Robins Cloud at 844-831-7370, or fill out our contact form for a free and confidential consultation with one of our Essure Attorneys.
When you consider permanent birth control, you want a safe and effective procedure. Essure is a permanent birth control device which reportedly has many side effects and complications ranging from chronic pelvic pain to unintended pregnancy and even death. If you have suffered these side effects or complications, you may qualify for an Essure lawsuit.
How does Essure work?
Essure is a permanent birth control device implanted into the fallopian tubes. The Essure device is a metal spring-like device with synthetic (PET) fibers implanted into each fallopian tube. The metal portion of the device is two different metals, typically a stainless steel inner coil and a nickel titanium coil. Once implanted, the Essure device intentionally causes an inflammatory response to encourage tissue to form around the Essure inserts. Within three months of implantation, this build-up of scar tissue is supposed to create a barrier to keep sperm from reaching the eggs thereby preventing contraception. The Essure permanent birth control procedure can be offered by doctors as an alternative to a tubal ligation.
Essure Side Effect and Complications
Severe complications caused by Essure include:
- Surgeries to remove the device and repair internal organs, such as a hysterectomy
- Migration of the Essure device or a device component
- Essure coil falling out of the body without any medical intervention, also known as expulsion of the Essure
- Perforation or tear of pelvic organs, including uterus or colon
- Life threatening ectopic pregnancy
- Chronic Pelvic pain
- Birth defects, including those caused by nickel poisoning as well as premature births due to membranes being ruptured by loose coils
- Irregular menstruation
- Allergic reactions to the device or device components, including headaches/migraines, rashes, and hair loss
FDA and Essure
Between November 4, 2002 and May 31, 2015 the FDA received 5,093 complaints related to Essure.1 The majority of these reports were received from women who suffered injuries from their Essure implants.
The most common problems were pain (3353), problems with menses (1408), headache (1383), fatigue (966), and weight fluctuations (936). There were also five reports of fetal deaths that occurred in women who became pregnant following placement of the Essure device. In addition, four adult deaths were reported.
Robins Cloud attorney Karen Beyea-Schroeder attended the September 24, 2015 FDA public meeting of the Obstetrics and Gynecology Device Panel “to discuss the risks and benefits of Bayer HealthCare’s Essure System for permanent female sterilization.” Karen met with women affected by the Essure device as well. The FDA Panel heard from women injured by Essure, medical experts and various professionals.2
The FDA presented evidence at this hearing about the high rates of adverse events such as the need for additional surgery, device perforation/migration, chronic pelvic pain and nickel allergies. At the end of a lengthy hearing, the panel voiced concerns about Essure :
- Concern about the lack of studies to determine allergies to the materials used to make Essure
- Concern about whether physicians were properly trained not only to implant the Essure device, but also if physicians knew how to remove Essure
- Concern about whether physicians know when Essure is not right for a patient. The panel also suggested that “patients with a known hypersensitivity to metal, autoimmune disease, history of pelvic inflammatory disease and those with a history of abnormal uterine bleeding may be less suitable candidates for the Essure system.”
- Concern about the need for additional studies to better understand complications, including complications up to ten years after implantation3
FDA Orders Bayer into Action
On February 29, 2016, the FDA reported the next steps Bayer must take for Essure to stay on the market. The FDA stated in this report that Bayer must perform the following actions:
- Mandatory clinical study to determine the real world implications of Essure and its heighten risks in women (a post market surveillance study)
- Black box warning that contains a “patient decision checklist”
- A proposed checklist informed consent document4
Call our Essure lawyers at 844-831-7370, or fill out the contact form for a free and confidential case review. Robins Cloud works on a contingency basis so there is no fee unless we obtain compensation for you.
A black box warning is the strongest FDA warning, suggesting that serious injury or death can result from the device. William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health stated that this February 2016 publication “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.”5
Essure Frequently Asked Questions
Essure is a permanent birth control device using a hysteroscope to implant the Essure device through the vagina into the fallopian tubes. Designed by Conceptus, Inc., the Food and Drug Administration approved Essure for use in November 2002. Since its approval, Essure has been linked to serious complications and side effects ranging from death to chronic pelvic pain and allergic reactions. Contact Robins Cloud LLP’s Essure Attorneys at 844-831-7370 for a FREE consultation regarding your Essure problems.
Robins Cloud LLP has thoroughly researched the ability to sue companies who try to hide using the PMA designation, like Bayer with the Essure permanent birth control device. The law allows certain claims such as negligence, breach of warranties, failure to warn about complications and manufacturing defect to be argued for medical devices like Bayer’s Essure device. In pursuing your Bayer Essure claim, you need to ensure you have a firm with the dedication, commitment and experience in fighting such battles. Heard Robin Cloud has the experience and knowledge necessary in prosecuting a PMA device, like Bayer’s Essure permanent birth control device.
Background About Essure
The Essure permanent birth control system was developed by Conceptus, Inc. between November 1998 and June 2001, when the FDA phase II and Pivotal patient testing was completed. In November 2002, Essure was FDA approved through the Premarket Approval process. Conceptus then conducted two Post-Approval Studies (PAS) as part of the PMA approval.
Conceptus’ PAS I study was to help determine the safety of the placement procedure as well as the safety and comfort of the Essure once implanted.6 Their PAS II study was to determine the ability to place the Essure into the left and right fallopian tube on first attempt for newly trained physicians. PAS II was also to ensure the training procedures and updated labeling were appropriate. Since Essure’s approval, numerous changes to the device and warnings have been reviewed and approved by the FDA.
On June 5, 2013, Conceptus, Inc. was purchased by Bayer AG and became a fully owned subsidiary of the Germany-based chemical and pharmaceutical company.
Several physicians have studied Essure. Physicians have written about thirteen reported cases of abdominal device migration since November 2014, but this number is being under-reported.7 Other physicians have published about pelvic pain associated with an Essure perforation8 or the development of contact dermatitis due to nickel allergy.9 In October 2015, the BMJ published that Essure had a “more than 10-fold higher risk of undergoing reoperation compared with patients undergoing laparoscopic sterilization.”10
Robins Cloud works hard to ensure those who have suffered side effects and complications get justice. We are actively working in the Essure litigation. Contact us now for more information on your potential Essure lawsuit.
7Rezai S, LaBine M, Gomez Roberts HA, Lora Alcantara I, Henderson CE, Elmadjian M, Nurtidinova D. “Essure Microinsert Abdominal Migration after Hysteroscopic Tubal Sterilization of an Appropriately Placed Essure Device: Dual Case Reprots and Review of the Literature,” Case Rep Obstet Gynecol. 2015; 2015:402197. doi: 10/1155/2015/402197. Epub 2015 Nov 18. Ricci G, Restaino S, DiLorenzo G, Fanfani F, Scrimin F, Mangino FP. “Risk of Essure microinsert abdominal migration: case report and review of literature.” Ther Clin Risk Manag. 2014 Nov 17: 10:963-8. Doi: 10/2147/TCRM.S65634.
8Casey J, Yunker A. Pelvic Pain Associated with Essure Perforation. J Minim Invasive Gynecol. 2015 Oct 21. doi: 10.1016/j/jmig.2015.10.003.
9Lane A, Tyson A, Thurston E. Providing Re-Essurance-to the Nickel-Allergic Patient Considering Hysteroscopic Sterilization. J Minim Invasive Gynecol 2015 Aug 7. doi: 10/1016/j.jmig.2015.07.020.
10Mao J, Pfeifer S, Schlegel P, Sedrakyan A. “Safety and Efficacy of hysteroscopic sterilization compared with laparoscopic sterilization: an observational cohort study,” BMJ. 2013 Oct 13: 351:h5162 doi: 10/1136/bmj.h5162