More than 16,000 lawsuits have been filed against Bayer and Conceptus Inc. (the manufacturers of Essure) by women who have suffered severe abdominal damage when the birth control device moves and punctures the uterus and fallopian tubes.
When women chose to undergo a permanent birth control procedure, they likely made that choice in full faith that it was a safe and effective means of preventing pregnancy. What many women later found out was that procedures involving permanent Fallopian tube implants such as Essure, have reportedly caused a host of serious side effects and complications in thousands of women ranging from chronic pelvic pain to even death.
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.
Attorneys claim that if doctors and patients had known the risks, then women would have chosen a different form of birth control, such as a hysterectomy, salpingectomy, tubal ligation, tubal fulguration, or application of clips.
Essure, which received FDA approval in 2002, is a small and flexible coiled device 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 coils cause scar tissue that then closes the tube and completes sterilization
When it was first introduced, it was hailed as a cheaper and safer option for sterilization that could be done in a doctor’s office rather than surgical suite.
However, for many women this has not been the case.
According to the Food and Drug Administration (FDA), the short-term risks from Essure include:
The Essure Confirmation Test used to confirm the reliability of Essure carries several risks of its’ own that may include:
Reported Long Term Risks of Essure can Include:
Other reactions have been reported in women with Essure, that have not been definitively confirmed to have been caused by Essure 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.
In July 2018, Bayer revealed that it would not sell Essure in the United States by the end of 2018. The permanent birth control manufacturer alleged its’ decision was based on commercial reasons rather than safety concerns.
It is notable that the device had already been discontinued by 2017 in other countries, following the requirement in November of 2016 of a black box warning (the U.S. Food and Drug Administration’s strongest warning) to be included on Essure packaging to warn of the risks of perforation, abdominal pain, and allergy, among other potential complications.
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.
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 advised that women already implanted with Essure should continue to use the device if it has been successful in preventing pregnancy, but stressed that such devices would no longer be available for implantation.
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’ post-market study obligations for Essure beyond 2019.
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.
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 Lawyers at Taylor Martino, P.C. would like to hear from you.