Essure
RDP Law Group represents women nationwide who have suffered from injuries or serious complications related to Essure birth control. If you or a loved one have experienced complications or injuries related to Essure, you may be entitled to compensation from the manufacturer.
As of August 20, 2020, RDP Law Group is no longer accepting cases for Essure
*** The information on this page is intended for educational purposes only. ***
$1.6 Billion Essure Settlement Announced
On August 20, 2020, Bayer announced it would pay $1.6 billion to settle Essure claims from women who have been injured by the defective birth control device. The proposed settlement will resolve about 90% of the nearly 40,000 claims against Essure manufacturer, Bayer A.G. who halted Essure sales in 2018 but did not recall the device.
Before Essure was recalled, more than 750,000 women received Essure implants and the FDA had received over 32,000 complaints and 10,000 adverse event reports related to Essure problems. Over 300 fetal deaths have been linked to Essure defects because of ectopic pregnancies in women who believed they could no longer become pregnant. The FDA even noted the skill level required to properly implant the coils in their proper position is beyond the level of most OBGYN doctors.
What you should to know about Essure
Essure is a permanent birth control device marketed as a safe alternative to tubal ligation. Promoted by German healthcare manufacturer Bayer HealthCare, Essure was touted as safe, non-surgical, non-invasive sterilization alternative that is 99.3% effective at preventing pregnancy. Essure can be inserted into a patient’s fallopian tubes in a doctor’s office in about 15 minutes with no post procedure down time. However, many women have experienced significant complications and debilitating side effects due to the design defects of Essure.
There are currently almost 40,000 lawsuits against Essure’s manufacturer alleging that Bayer knew about the design defects but failed to provide stronger warnings so doctors and patients could make an informed decision.
At RDP Law Group, we call this putting profits before people which is our rallying cry to fight for justice for our clients.
Unfortunately, many women have experienced severe side effects and complications after the implementation of Essure. For such patients, Essure coils can be surgically removed, however fertility is not typically restored.
Common side effects and injuries from Essure include:
- Heavy bleeding and discharge
- Abnormal blood clots
- Severe bloating and weight gain
- Debilitating chronic pain
- Coil migration
- Wrongful death
- Ectopic pregnancy
- Migraine headaches caused by an allergic reaction to the device
- Additional surgeries including full or partial hysterectomy
- Coil breakage
- Autoimmune disorders
- Metal allergies
- Hair loss
- Back pain
- Fetal death
- Abdominal surgery
- Perforation or tearing of the pelvic organs including the uterus and fallopian tubes
Essure Litigation Against Bayer
Women are seeking damages for injuries caused by Essure:
- Pain and suffering
- Mental and emotional anguish
- Past and future medical expenses
- Loss of wages
- Diminished quality of life
- Punitive damages to punish Bayer for knowingly marketing an unsafe medical device to women.
How Essure Works
Essure is a spring coil device wound with synthetic fibers designed to be inserted into the fallopian tubes where it creates an inflammatory response causing scar tissue to form which blocks the tubes and prevents pregnancy. The synthetic fibers encourage the surrounding tissue to adhere to the coil device creating a barrier of scar tissue intended to block sperm from reaching the eggs.
Essure product recall in Canada
Bayer voluntarily discontinued the sale of Essure in Canada claiming the decision was based on a decline in patient demand, not a product recall. Subsequently, in July 2018, Bayer issued a press release stating that it would halt sales of Essure in the U.S. on December 31, 2018. The press release stated the decision was based on a decline in U.S. sales over the past several years. Clearly Bayer realized the potential mounting liability created by Essure’s defective design outweighed the potential profits it expected to make from the defective product.
Originally hitting the market in 2002, Essure was designed and manufactured by a small U.S. based company called Conceptus Inc., that was later purchased by German conglomerate Bayer A.G. in 2013.
Timeline of Events
November 2002
Conceptus, Inc. receives FDA approval for Essure as a Class III medical device after completing the Premarket Approval (PMA) process.
June 2013
Conceptus, Inc. is acquired by German conglomerate Bayer A.G. Read more.
February 2016
FDA requires Bayer to conduct a clinical study on the safety and efficacy of Essure. Read more.
October 2016
FDA requires Bayer to add a black box warning to Essure labelling. Black box warnings are the FDA’s highest level of warning and indicate that a product may cause death or serious injury. Read more.
September 2017
Bayer announces plans to halt sales of Essure outside of the U.S. for commercial reasons not linked to the allegations about the safety of the device. Read more.
April 2018
July 2018
Bayer discontinues sales of Essure birth control in the U.S. after December 31, 2018. Read more.
What Should You Do Next?
If you are experiencing pain and suffering that may be related to Essure, the first thing to do is contact your doctor to see if additional treatment or device removal is recommended. If a defective birth control device is the culprit, it may be time to consider contacting an experienced Essure attorney to file a claim for damages against the device manufacturer, Bayer A.G. Below are a few steps you can take to prepare for filing your claim.
- Call facility for medical records
- Document the level of your Essure injuries and complications
- Contact RDP Law Group for a free case evaluation
Call Facility for Medical Records:
If you don’t already have them, contact the medical facility where the defective Essure device was implanted and request that they send you all of your medical records including the operating report and billing statement. The operating report will include the product ID and Lot Number to identify the Essure device that was used during your procedure.
