More than 16,000 women who opted for permanent, irreversible birth control by way of Essure, are suing device manufacturer Bayer after suffering harm from the implanted coils. Essure Birth Control Lawsuits claim that the non-surgical sterilization tool can became dislodged or break apart resulting in migration, severe pain, heavy bleeding, and damage to nearby organs, such as the bladder or bowel. Essure injuries have led to emergency surgical procedures, serious illness, permanent disability, and in some cases, death.
Essure is a permanent birth control device implanted in females for sterilization. It cannot be reversed if a woman later decides to try to get pregnant.
The coiled device is small and flexible and made of metal and fiber. The procedure for its’ implantation is non-surgical, meaning a surgical incision and general anesthesia are not needed. Instead, each coil is inserted in the fallopian tubes using a hysteroscope, or a flexible tube with a small camera on the end, that travels through the vagina and cervix and into the uterus.
The fallopian tubes are responsible for carrying the eggs from the ovaries to the uterus. Once in place, Essure creates a build up of scar tissue that forms around the devices, thereby blocking a male’s sperm from reaching the eggs for fertilization and subsequent conception. The process of tissue formation takes about three to six months’ time and therefore, it is not immediately effective in preventing pregnancy.
Essure does not contain or release hormones. It is also not intended to protect against sexually transmitted diseases.
Women reported short-term and long-term risks associated with Essure in clinical trials. There are also unknown risks to women with Essure and mild to severe reactions included in medical device reports submitted by health care providers to the U.S. Food and Drug Administration (the federal agency tasked with the review and monitoring of medicines and medical devices).
Short-term risks (or those occurring during or immediately after the placement procedure) of Essure might include:
Rarely, part of the Essure insert might break off during placement. There is also a slight risk of perforation of the uterus or fallopian tubes by the instrument used to place the birth control device. Lastly, Essure might be expelled from the body after the placement procedure.
The Essure Confirmation Test used to confirm the reliability of Essure carries several risks of its’ own that may include:
Long-term risks of Essure can include:
Clinical studies show that Essure placement does not take in about 8 percent of women and therefore, the device cannot be relied on for effective birth control.
Other reactions have been reported in women with Essure. These reactions that have not been definitively confirmed to have been caused by Essure or possibly something else include:
Other unknown risks of Essure include the safety and effectiveness of reversing the Essure procedure. Additionally, the safety and effectiveness of Essure has not been established in women under 21 or over 45 years of age.
Bayer stopped selling and distributing Essure in the U.S. at the end of 2018. The device had already been discontinued in other countries in 2017, following the requirement of a black box warning (the U.S. Food and Drug Administration’s strongest warning) to be included in device packaging beginning in 2016. The permanent birth control manufacturer alleged its’ decision was based on commercial reasons rather than safety concerns.
Despite the halt on sales, health care providers that previously purchased Essure devices were permitted to implant the sterilization device in patients up to one year from the date it was bought and paid for. But starting in September 2019, Bayer informed its’ customers that any Essure devices that had not yet been implanted should be returned to the manufacturer by the end of 2019. All purchasers were given instructions direct from the device manufacturing company on how to return their unused Essure units.
On January 10, 2020, the U.S. Food and Drug Administration (FDA) issued a statement that all unused Essure units should have been returned to Bayer as of December 31, 2019. The federal agency further noted that such devices were no longer available for implantation but advised that women already implanted with Essure should continue to use the device if it has been successful in preventing pregnancy.
The FDA continues to collect long-term safety information from women who have received the device. Additionally, the federal agency is mandating that Bayer continues to meet its’ postmarket study obligations for Essure beyond 2019.
According to the FDA: “We believe clinical data from this postmarket study will help patients, health care providers, and the agency better understand certain complications that women who have Essure permanent birth control may experience when compared to women who undergo tubal ligation. We will continue to provide updates on our ongoing postmarket evaluation of Essure to the public as new information becomes available.”
We know your journey is difficult and complicated. But you don’t have to struggle with this alone. Our attorneys are knowledgeable about legal claims involving Essure injuries. Let us help answer your questions and get you back to feeling like “you” again.
Lawsuits claim that Essure can migrate or move from the fallopian tubes into the abdomen and pelvic areas, perforate or cause damage to nearby organs such as the bladder and bowel, break into pieces and/or corrode. Even after surgery to remove the device when complications arise, patients can be left with metal fragments in their bodies. Sometimes, multiple surgeries are needed to correct harm caused by Essure. Women report experiencing chronic sometimes severe or debilitating pain, inflammation, bleeding, achy joints, fever and other illness after being implanted with the permanent birth control coils.
Patients injured after being implanted with Essure likely have mounting medical expenses as a direct result of the device manufacturer’s alleged concealment of dangers associated with the permanent birth control option. An experienced attorney can help evaluate your claim and assess damages specific to your case to get you the maximum compensation you deserve. Compensation awarded might include past, present and future medical bills for treatment, co-pays, surgeries, therapies, medical equipment and prescription medications. Compensation can also be determined for pain and suffering or emotional distress resulting from your injury as well as punitive damages—intended to punish the guilty party for gross negligence or intentional wrongdoing.
There are presently no class actions or consolidated federal cases for Essure lawsuits. Injured patients require the assistance of a knowledgeable attorney to file an individual lawsuit in the proper jurisdiction containing the appropriate claims. Other Essure victims have already received dates for trial, though no settlements or jury verdicts have happened yet.
It is important to speak with your doctor if you have concerns about your Essure implant. If you are not having side effects after being implanted with Essure, and the device is working well to prevent pregnancy, removing the device might pose additional unnecessary health risks. The procedure to remove Essure is more involved than the procedure used to place the coiled device.
If you are experiencing severe symptoms with Essure, you need to seek immediate emergency care.
If you were injured after being implanted with Essure, you might qualify for an Essure lawsuit. You will need to show that your injury was the direct result of the permanent birth control device. An experienced attorney can review your case and medical history to help establish your claim.
If you or a loved one have sustained Essure birth control injuries after implantation, our Essure injury lawyers are here to help! We are are offering FREE legal consultations with our experienced Essure lawsuit lawyers to those who may have suffered both medically and financially due to the Essure permanent birth control device.
We promise to work hard for you as you bring forth your Essure injury claim against Bayer, protecting your confidentiality and defending your rights along the way. We can handle all aspects of your claim from start to finish, as well as answer any questions to help determine if you are eligible to pursue financial compensation.
The Essure Injury story is one of flawed testing and deceptive marketing tactics, leaving thousands of women to suffer horrific pain and injury. If you are one of those women, the Essure Injury Attorneys at Taylor Martino, P.C. would like to hear from you. Please fill out our case evaluation form or contact us by phone at 1-800-256-7728 for a free, no obligation consultation.