Essure Lawsuits Claim Device Failure Can Puncture Uterus and Fallopian TubesMarch 25, 2019
Essure Lawsuits Being Filed
Since 2002, there have been thousands of complaints from women implanted with a Bayer Essure birth control device, not to mention more than 16,000 Essure Lawsuits. Yet it was not until July 20, 2018 that Bayer finally announced it would be ending sales of the Essure device for “business reasons.” The Essure device was even a part of a Netflix documentary on the dangers of medical devices, titled The Bleeding Edge.
What is Essure?
Perhaps the primary selling point of the Essure birth control device is the fact that it takes only about 10-15 minutes in a doctor’s office to insert the device, and there is no need for anesthesia or incisions. Essure is comprised of two nickel alloy coils which are inserted into entrance to each fallopian tube, via a thin metal catheter. Once implanted, the metal coils expand to about an inch and a half, anchoring to the fallopian tube walls.
After three months or so—during which a backup birth control method must be used—scar tissue forms around the inserts, resulting in what doctors say is a non-surgical, permanent method of birth control. Although a woman who is implanted with an Essure device will continue to release eggs, the sperm will be unable to reach the eggs, which will then break down and be reabsorbed by the body.
Essure, like tubal ligation, is considered a permanent method of birth control—Bayer states the device is 99.3 percent effective, based on a recent clinical study. Since the Essure was placed on the market in 2002, it is estimated some three-quarters of a million women across the globe have had an Essure device implanted.
Problems with Essure
The FDA has a database where patients, doctors and manufacturers can report any injuries, malfunctions or even deaths associated with a medical device or prescription drug. The adverse event reports received by women regarding Essure include claims of:
- Severe pelvic pain;
- Severe abdominal pain;
- Internal bleeding;
- Autoimmune problems;
- Perforation of the Fallopian tubes or uterus;
- Hair loss;
- Vertigo and nausea;
- Device migration;
- Device expulsion;
- Miscarriages, and
Is Bayer Protected from Essure Lawsuits?
Essure was actually approved for the original manufacturer, Conceptus, through a fast-track process with a caveat: Conceptus was told to follow study participants for at least 4-5 years, following implantation of Essure. The long-term study was completed in 2007, however the data was not published until 2015. Concern was expressed by some that only 70 percent of the trial participants were followed for the full five years.
Normally, a Class III medical device must go through a fairly stringent Premarket approval process, as well as a scientific review of the device prior to marketing. Since a Class III medical device is one that is meant to “support or sustain human lives,” a malfunction is, presumably, unacceptable. Class III medical devices include implanted pacemakers, cerebral simulators and heart valves, and, of course, the Essure birth control device.
Deaths Associated with Essure
Because there have been 26 reports of death related to Essure, the lawsuits against Bayer have mounted quickly. Six of those reports related to four adult deaths, 18 reports related to 15 incidences of loss of pregnancy, and the final two reports were related to two infant deaths after live birth. The four adult women reportedly died from suicide, air embolism, uterine perforation and infection.
Were Results of the Conceptus Study Falsified?
After several women came forward to say the results of the study done by Conceptus were falsified, the FDA began investigating the situation, finding at least six cases of possible tampering. Despite this, the FDA concluded the possible tampering was “sporadic,” and “did not reveal a pattern.” Many of the Essure lawsuits claim Conceptus, the original manufacturer, committed fraud during the premarket approval process, therefore are not entitled to protection. While Essure was still on the market, the FDA placed a black box warning on the device—the strongest warning required by the FDA.
Helping Clients Who Have Suffered Harm from an Essure Device
Clients injured after implantation of a dangerous Essure device could find themselves with significant medical expenses as well as pain and suffering. These women could even be unable to work due to the severity of their symptoms. USClaims can help your clients pay medical expenses related to an Essure device as well as their day-to-day and regular monthly expenses in anticipation of a court judgment or settlement.
At USClaims, we offer pre-settlement funding, if a case is qualified for pre-settlement funding then we would purchase a portion of the proceeds of the anticipated court judgment or settlement for some cash now. USClaims only gets paid if a case is won or has reached a settlement! Apply now or call us today at 1-877-USCLAIMS to learn more.