The safety of a permanent birth control implant called Essure has been called into question after almost 10,000 women have reported negative effects from the device to the Food and Drug Administration (FDA). The complaints range from heavy, painful menstrual bleeding to cases where surgery was required to remedy the pain experienced by Essure users, and include several reports of fatalities.
Now, some women who have used Essure have taken their concerns to court, with Essure lawsuits filed against Bayer, the manufacturer of the device.
What is Essure?
Marketed at women who have decided not to have children or not to have any more children, Essure has appealed to women as an alternative to tubal ligation and a permanent form of birth control. The implant, which is meant to be permanent, can usually be inserted at a doctor’s office without general anesthesia.
The Essure device comprises two coils made from a variety of metals and polyethylene fibers. It is implanted with the coils positioned at the entrance of the fallopian tubes. Once in place, the coils expand and become fixed to the walls of the tubes. Eventually, scar tissue builds up around the coils and closes off the fallopian tubes, preventing sperm from entering.
The convenience of Essure may be outweighed by its associated risks, which include the possibility of the device poking through the uterus or fallopian tubes, and the potential for persistent pain after implantation that may last for weeks and months.
Common Complaints of Essure Users
Of the thousands of adverse effects that have been reported concerning Essure, the most common are:
- Pain/abdominal pain
- Heavier menses/menstrual irregularities
- Weight fluctuations
For some women, these complications are severe enough to require surgery—and in some cases multiple surgeries—to remove the Essure implant. Another factor for Essure users is that not all doctors have been trained in the removal of the device, which can cause further problems during removal.
There have been reports of fatalities associated with the use of Essure, though those fatalities cannot be directly linked to the birth control. According to reports, the FDA received three reports of late-term miscarriages and a report of the death of a women all of which involved Essure. Meanwhile, ABC News reports that a woman died while a doctor was inserting the second birth control coil in her fallopian tube. Although the woman’s uterus was shown to have been punctured, it is not clear whether Essure itself caused her death.
Essure in Studies
Prior to being approved by the FDA in 2002, Essure underwent a Phase III clinical trial. About 700 women between the ages of 21 and 45 were studied in the United States, Australia and Europe for one to two years—a length of time that has raised concern because the device is intended to be used for the duration of the woman’s life.
After its initial clinical study, Essure was approved by the FDA under its premarket approval process, with the caveat that then-manufacturer Conceptus would conduct two post-approval studies. The follow-up studies would follow the initial clinical trial patients for five years, but by the completion of the five years, only around 360 Essure users would complete the study. Since then, Conceptus was purchased by Bayer, which continues to manufacture and market Essure.
On February 29, 2016, the FDA requested an additional mandatory clinical study for Essure after receiving thousands of complaints about the birth control implant. The study will follow 1,400 women who use the Essure device for five to six years, and will contrast those patients by also following 1,400 women who opt for traditional sterilization through laparoscopic surgery. The first reporting from this study is due in March of 2017.
At the same time, in February of 2016, the FDA announced that they would be requiring a boxed warning on Essure packaging, and a detailed Patient Decision Checklist, intended to alert patients to the potential risks of the device and to be signed by both doctor and patient. These decisions, and the decisions to call for another clinical study, came after an FDA Advisory Committee meeting on September 24, 2015.
Critics say that those steps are not enough, however, and that Essure should be removed from the market.
Bayer’s Response to Concerns over Essure
Following the FDA’s announcement of their stricter requirements for Essure, Bayer promised, in a press release, that they would work with the FDA on implementing measures that would “support the continued safe, effective and appropriate use of Essure.”
“Patient safety and appropriate use of Essure are our greatest priorities” Dario Mirski, M.D., senior vice president and head of medical affairs Americas at Bayer said in a statement within the release.
Throughout Essure’s time on the market, Bayer has continued to maintain that the permanent birth control implant has benefits that outweigh its risks, and that its studies show minimal side effects or unwanted pregnancies. In their five-year follow-up study, however, Bayer did identify two patients as having had hysterectomies to remedy conditions they experienced while using Essure.
Essure’s History of Hysterectomies
Of all the adverse events reported by Essure users to the FDA, perhaps the most alarming are the incidents where women ultimately underwent hysterectomies to remedy the pain resulting from the Essure implant.
Becky Beesley was working as a teacher when she decided to get the Essure implant. She started feeling negative effects instantly, including vomiting immediately following the placement of the device. As the months went on, Beesley’s pain grew worse, eventually leading to her quitting her teaching job. She had the Essure implant removed, but the pain stayed behind. An eventual X-ray revealed that there were still pieces of the coil from the Essure device inside her uterus. To remove them, Beesley would have to undergo a hysterectomy.
“It’s sad. I try not to cry about it. This has been a really difficult situation for me” Beesley said when speaking with ABC15.
Kim Meyers is a former competitor in rodeo-style barrel horse races, but after she chose to get Essure implanted, her pain prevented her from competing. Doctors discovered that the coils of the Essure device had pierced her fallopian tubes. They removed it, but, once again, the pain remained. Finally, three years later, Meyers opted for a hysterectomy, during which her surgeon found a piece of metal coil from the Essure device was stuck in her uterus.
“Doctors kept saying there was nothing wrong with me,” Meyers said in an interview with the New York Times “I knew, with every fiber of my being, there was still something there.”
They are just two of the women who’ve come forward since choosing Essure and ultimately had hysterectomies. Many more have testified with the FDA alleging that Essure caused them harm.
Although litigation is in early stages, Essure is already the subject of lawsuits from thousands of women, and a potential class action lawsuit is underway in Canada.
Most of the lawsuits allege that Bayer was negligent in their research prior to marketing Essure as permanent birth control, and that the company should not continue to market Essure in light of the adverse affects that have been reported.
Essure Implant Lawyer
Women who had the Essure device implanted and experienced adverse effects may be eligible to file an Essure lawsuit. If you would like to obtain a free evaluation of your case and determine your legal options, contact Patterson Dahlberg, where our expert attorneys can provide detailed information on your rights.