Essure is a permanent birth control device that was developed by Conceptus, Inc. and eventually bought by Bayer. The company designed Essure to be a less-invasive alternative to tubal ligation, a surgical and permanent birth control. Inserting the device is less-invasive as compared to surgical options, but some of the other claims made by Bayer about Essure have come under question, including its effectiveness.
In addition to questionable claims, critics have also found issues with how the device was tested and how clinical trials were conducted. Most problematic of all for Bayer have been the reports of adverse events including severe pain and bleeding, and even organ perforation and unintended pregnancies. Essure lawsuits face an uphill battle, as Bayer has some protection against them, but this hasn’t stopped women who have been harmed by the device from fighting back.
What is Essure?
Essure is the first device on the market to offer permanent birth control without the need for surgery. Prior to this device, created by Conceptus, but owned and controlled now by Bayer, women needed to have surgery for a tubal ligation in order to achieve permanent protection against pregnancy. Surgery always comes with risks, so an alternative that is less invasive should be safer.
The device includes two metal coils that are implanted in the fallopian tubes. This is done without any surgical incisions, using a hysteroscope to insert the coils, and it takes just about ten minutes in a doctor’s office. The coils trigger inflammation in the fallopian tubes, which results in scar tissue that blocks the tubes and prevents any eggs from moving through them from the ovaries to the uterus.
Recovery time is minimal, and women receiving the device are able to go right back to normal activities the same day. The build-up of scar tissue takes time, about three months. Women with the device go back to the doctor for an examination to be sure the scar tissue has fully formed. This needs to be confirmed before a woman can rely on the device to provide effective birth control.
Complications Lead to Lawsuits
Because the insertion of the Essure device is not surgical, there are supposed to be fewer risks of complications. With surgery, like a tubal ligation, there is a possibility of a bad reaction to anesthesia, bleeding, blood clots, and infections. These risks should be minimized with non-invasive Essure, but the device has been shown to cause other, often very serious complications.
The U.S. Food and Drug Administration approved Essure in 2002 and since then have received thousands of reports from women of adverse events that occurred because of the device. Women report having severe low back and pelvic pain, heavy bleeding, and other serious complications. Some of the most severe are cases in which the device perforated the fallopian tubes and migrated to other parts of the body, causing damage to organs and tissues.
Some of these women had such serious damage caused by the device that they had to have hysterectomies, removals of the uterus. This is major surgery that has consequences like sexual dysfunction, bowel problems, incontinence, pelvic pain, and organ prolapse. Many of the women who have suffered because of Essure have tried to file lawsuits against Bayer, but so far without much success thanks to protection that the company has against such suits.
There have even been deaths associated with the use of Essure. The FDA has collected several reports of deaths, many of which were the deaths of infants or lost pregnancies. As many as four women may have died directly because of the use of Essure, with causes of death being reported as infection, intrauterine perforation, suicide, and embolism.
Questionable Claims and Trial Data
In addition to complications, there are other serious issues with Essure. One is that Bayer has made claims about the effectiveness of the device that have been called into question. The company claims that Essure is 99.74 percent effective in preventing pregnancy, a rate higher than other types of birth control. Critics say that the effectiveness rating applies only to the clinical setting of the trials, and would not be as high in the real world. This claim may be misleading to women who believe the device to be more effective than it really is.
There have also been serious concerns regarding the way in which Essure was tested. The FDA fast-tracked approval of Essure, but in doing so required that Bayer follow up with more studies and track participants for at least four years after receiving the device. The results of that study were not published for eight years, an unusual delay.
Those results showed that only 366 of the 500 women were followed for the required minimum of four years and that 15 of those women required hysterectomies because of complications. Less serious, but still consequential complications included heavy periods for 38 percent of the women, chronic pelvic pain for 20 percent, and painful intercourse for many. The delay in publishing the results means that thousands of women had Essure implanted without access to all the information about complications and risks.
Lawsuits are pending against Bayer because of complications and trial controversies with Essure, but the company is preempted from lawsuits. FDA preemption protects medical device makers from certain claims and lawsuits. It is not impossible to get justice, but it is challenging. Some cases have already been thrown out by judges because of preemption.
Several of these were dismissed under certain claims, but a judge recently allowed several Essure lawsuits to proceed based on claims that Bayer failed to warn patients about risks and that the company was negligent in making certain claims about the device. These women and their representation now have the chance to make their cases and to win compensation.
Some of the women involved in the lawsuit include one who experienced fallopian tube perforation because of Essure. She suffered heavy bleeding and pain and had to have surgery to remove the broken device and her fallopian tube. Another woman claims that she had Essure implanted when a Bayer representative was supposed to be on hand to guide the doctor. That representative never came and the doctor failed several times to implant the device correctly. The result was pain, more surgeries, and permanent damage.
Can You File an Essure Lawsuit?
If you had Essure implanted and suffered complications, filing a lawsuit may not be simple. Because of FDA preemption, Bayer is protected from certain claims. Most recently the women allowed to proceed had certain of their claims dismissed, such as the device causing them permanent damage. The process for suing Bayer for this device is complicated, but a lawyer can help guide you, help you decide if you have a case, and take you through the necessary steps.