UPDATE: (March 2020) – The first Essure jury trial has been postponed once again and is now expected to begin sometime in late May or June in Alameda County, California.
There are approximately 32,000 cases now pending against the company nationwide.
UPDATE: (March 18, 2019) – From the International Consortium of Investigative Journalists:
(Author: /March 18, 2019)
“The FDA is … increasing its scrutiny of nitinol.” — “Nitinol is an alloy containing nickel that is used in Essure. Many patients have reported allergic reactions to Essure and the U.S. Centers for Disease Control have estimated that between 10 and 20 percent of the population is allergic to nickel.”
At the end of December 2018, Bayer ceased production and sale of all Essure birth control implants in the U.S. The FDA received roughly 12,000 Adverse Event Reports (“AER”‘s) related to Essure in 2017 alone.
UPDATE: (July 23, 2018) – Bayer has announced it is removing the Essure birth control device from the consumer market. Although Bayer is claiming the withdrawal of the Essure device is due to a sharp decline in sales (“the Essure business is no longer sustainable”) it is likely the 16,000(+) lawsuits currently pending against the company have something to do with their decision.
The Consumer’s Guide to Essure Birth Control | By Jeneen Interlandi | Consumer Reports Magazine [8/17/17]
“So many women in our group have gone back to the doctors who handled their Essure implants, only to be told that the doctor doesn’t offer removal services,” Rusmisell says. “It’s a very frustrating and scary place to be: They have this thing in their bodies that’s making them sick, and none of the doctors they talk to know what to do.”
By: Elizabeth Whitman | November 22, 2016 | (Modern Healthcare Magazine)
According to a study published on October 13, 2015, in the medical journal the BMJ, women who undergo the Essure birth control procedure may be ten times more likely to need additional surgery due to complications than women who undergo tubal ligation, an alternate form of sterilization. “A more than 10-fold higher occurrence of reoperation during the first year following Essure-based surgery is a serious safety concern,” the researchers wrote in their report.
The automobile industry routinely recalls vehicles when there is the slightest hint of any defect. Shouldn’t there be equal concern and compassion for women? WHY HAS THE FDA IGNORED THE 32,000+ complaints received from Bayer?
If you or a loved one have been implanted with the Essure Birth Control device you may have legal rights you need to protect. Contact us online or call immediately at 1-866-252-3535.
UPDATE: (June 2016) – According to a new study out of Northwestern University, the US Food and Drug Administration used faulty data in its approval process for the Essure sterilization device.
“Our results reveal significant weaknesses in the preapproval and post approval regulation of high-risk obstetrics and gynecology devices,” the authors said.
The device has been the subject of approximately 10,000 formal complaints to the FDA, which has been accused of downplaying its effects, which include both debilitating harm to women and deaths of babies conceived despite their mothers using the device.
Published April 23, 2016 in the medical journal Contraception: researchers compared the risk of pregnancy among women using the Essure device versus undergoing laparoscopic sterilization (i.e., getting their tubes tied) and found those using Essure are more than 10 times more likely to get pregnant, over a 10-year period, than those who get their tubes tied. Researchers ran computer models that revealed Essure’s true pregnancy risk – in sum, pregnancy rates in the first year for women using Essure are 57 per 1,000 women, compared with about 3 to 7 per 1,000 women for laparoscopic sterilization.
The FDA has now acknowledged it received over 9,900 Adverse Event Reports as of the close of 2015. It is notable that the FDA acknowledges it only receives reports for about 10% of actual adverse events.
A few short months ago that number was 5,093.
Bayer has now acknowledged receiving over 30,000 reports of adverse events. To be more specific, Bayer turned over 16,581 complaints to an FDA investigator for the 2 year period of January 1, 2008, through December 6, 2010. Bayer turned over another 16,047 complaints to another FDA investigator for the 2 year period of January 1, 2011, through December 2013.
UPDATE: (March 1, 2016) – Yesterday, the FDA announced they had concluded Essure warranted a “black box warning” label – a label “designed to call attention to serious or life-threatening risks,” and additional study of the device, according to the FDA’s website.
U.S. Representative Mike Fitzpatrick, who has been a vocal critic of Essure and has called for the device to be recalled from the market, pronounced, “it’s unbelievable that it took the FDA since September to make just two recommendations with no enforcement measures and ask the manufacturer to perform another study while leaving Essure on the market.” … “The evidence is all there: Tens of thousands of injured women and hundreds of fetal deaths.” Fitzpatrick said because the FDA failed to act, “I believe Congress must.”
We agree Representative Fitzpatrick.
Female consumers will continue to be used as guinea pigs for Bayer and the FDA while they purportedly “study” what the actual risks of the Essure device are, 14 years after the device was first put on the market.
Despite the FDA’s announcement, Bayer’s PMA “shield” from liability and civil lawsuits is looking quite flimsy; the “black box” label change acknowledges that the original warnings provided by Bayer were insufficient.
UPDATE: (Feb. 18, 2016) – Representative Mike Fitzpatrick has called on the FDA to take action, advising the FDA that “post-marketing surveillance consulting firm” Device Events has identified at least 303 reports of fetal deaths linked to the Essure procedure, compared to only five that the FDA has reported.
Representative Fitzpatrick sent a letter to Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, requesting the FDA address Device Events findings compared to the FDA’s analysis of Essure’s safety concerns: “In light of this immense discrepancy, I request that the FDA conduct a thorough review of … all of the adverse event reports received by those harmed by Essure as part of FDA’s on-going review of this medical device,” Fitzpatrick wrote in the letter.
The FDA is currently reviewing the safety of the device and has said it expects to issue a decision about the Essure Birth Control system sometime this month.
REVIEW the LETTER and accompanying documents here.
“If the FDA or manufacturer aren’t willing to act in the best interest of these women, Congress must.”
– Rep. Mike Fitzpatrick
UPDATE: (Dec. 1, 2015) – A number of lawmakers are calling for the Food and Drug Administration (FDA) to force Bayer to issue a recall for the Essure birth control implant, calling for the agency to withdraw its original approval amid reports of complications and problems experienced by women.
Representative Mike Fitzpatrick, a Republican from Pennsylvania, has introduced the E-Free Act in the U.S. House of Representatives on November 4. If approved, it would revoke the pre-market approval given by FDA to Essure’s original developer, Conceptus, in 2002.
This would require Bayer, who currently owns and distributes the birth control implant, to remove Essure from the U.S. market.
The FDA is currently reviewing data on adverse events associated with Essure and is expected to publish its recommendations in late February of next year (2016).
UPDATE: In September 2012, the journal Contraception published a case report on a 42 year-old woman who developed nausea, vomiting, abdominal pain, and bloating one month after receiving an Essure coil. She was diagnosed with a small bowel obstruction, and doctors wrote: “[Essure] had caused strangulation and local perforation of the bowel wall.” She underwent emergency surgery to remove the Essure coil and removed the damaged portion of her intestines.
We are investigating potential lawsuits involving the Essure birth control implant, as it has been tied to an increased risk of very dangerous side effects.
Approved by the FDA in 2002 via the FDA’s “fast track” system of review, Essure is a non surgical permanent form of birth control consisting of a pair of small nickel-titanium coils wrapped in polyethylene terephthalate (PET) fibers. The coils are placed in the fallopian tubes, prompting tissue growth into and around the coils, which blocks sperm from fertilizing a woman’s eggs.
One problem is the nickel-titanium alloy which many, many women are allergic to and causes a plethora of health issues. Worse, reports indicate the Essure device has a tendency to migrate elsewhere in the body after implantation which may result in multiple surgeries to remove the device and/or address any internal damage caused by the device (i.e., perforated or damaged organs such as the uterus and the fallopian tubes).
In June of 2015, the FDA added risk information to it’s website related to Essure. However, the bottom line is that the Essure devices were not properly tested for dangerous side effects before they were ever put on the market in 2002. The FDA has received at least 5,093 adverse event reports since Essure Birth Control was approved in 2002; there were 152 complaints filed in the FDA’s Manufacturer & User Facility Device Experience database in 2012; in 2014 there were 2,259 complaints filed in the MAUDE database, a 1,386% increase. In 2015 there were at least 1,363 MAUDE complaints filed with the FDA.
If you or a loved one have been implanted with the Essure Birth Control Device you may have legal rights you need to protect. Contact us online or call immediately at 1-866-252-3535.