Essure Problems: Lawsuits Filed Over Birth Control Implant
Over the last 14 years, more than 750,000 women have opted for Essure, a permanent birth control implant manufactured by Bayer. But as thousands of women have learned, Essure may not be the “simple”, out-patient sterilization procedure that Bayer advertised. Patients say Essure can cause a litany of debilitating side effects, including:
- abnormal, painful menstruation;
- chronic back and pelvic pain;
- severe nickel allergy reactions; and
- disabling migraine headaches.
Unplanned pregnancy, the very event Essure was designed to prevent, has been reported hundreds of times, leading some critics to suggest that the implants may not be as effective as the manufacturers say. Suffering for months, or even years, from these inexplicable problems, many women have turned to their doctors, discovering too late that the metal coil implants have migrated, moving painfully into the hip or pelvis, or perforated their fallopian tubes and/or uterus entirely. But these women have not fallen silent. Far from it. The FDA has received more than 10,000 severe adverse event reports involving Essure, according to the New York Times editorial board. Since 2013, the majority of these reports have been submitted by patients of their own accord, not doctors.
Can Women Fight Back?
Yes. In fact, hundreds of Essure recipients have already chosen to file product liability lawsuits against Bayer. Many other women may be eligible for compensation, and our attorneys can help. Rob Jenner, is the founding principal at Jenner Law, and has gathered an alliance of dedicated personal injury attorneys to investigate potential Essure lawsuits. Rob is joined by Elizabeth Graham, who leads the complex medical device litigation practice at Grant & Eisenhofer, P.A. Together, Rob and Elizabeth share nearly four decades of experience fighting major pharmaceutical corporations in the name of consumer rights. To learn more about our Essure lawyers, click here.
Why Are Women Filing Essure Lawsuits?
Essure was first approved by the U.S. Food & Drug Administration (FDA) in April of 2002. At that time, the device was being manufactured by Conceptus Inc., a small company now wholly owned by Bayer. Like all “Class III” medical devices, which the government believes could present “a potential, unreasonable risk of illness or injury,” Essure underwent the FDA’s Premarket Approval process. According to the FDA, Premarket Approval is “the most stringent type of device marketing application.” While the approval process eventually found Essure to be reasonably safe and effective, this process also shielded the device’s manufacturer from product liability claims. As we’ve seen, Essure’s safety has been called into question. The legal protection enjoyed by Bayer has now been challenged, too. In a string of lawsuits filed in Pennsylvania, California, Idaho and elsewhere, women say Conceptus fraudulently manipulated data from the implant’s clinical trials. If the court finds in favor of Plaintiffs, Bayer’s protected legal status could be revoked, opening the door for thousands of injured women to file Essure lawsuits against the company.
How Does Essure Work?
As its current manufacturer is fond of noting, Essure is the world’s only permanent birth control procedure that doesn’t require surgical intervention. In their lawsuits, Plaintiffs have disputed this characterization – observing that most healthcare providers classify Essure as “surgical” since surgical equipment is required to implant the device. Essure is not tubal ligation, or “getting your tubes tied,” during which a woman’s fallopian tubes are clamped or sealed by a surgeon. Instead, the Essure “procedure”, which, according to Bayer, is supposed to take less than 10 minutes, involves placing two, metal coil micro-inserts inside each fallopian tube at the junction of the uterus. The Essure coils are coated in polyethylene terephthalate, or “PET” fibers. After insertion, these fibers embed themselves into the tissue of the fallopian tubes, promoting the body’s natural inflammatory response. Then, over the next few months, scar tissue grows around the coils, forming a barrier and preventing eggs from reaching the uterus. Three months after insertion, an Essure Confirmation Test, or hysterosalpingogram, is performed to confirm that the coils are in place and that the fallopian tubes are completely occluded (blocked).
Can The Procedure Be Reversed?
No, the Essure procedure is not reversible. Like tubal ligation, or a vasectomy for men, Essure is a permanent means of birth control. However, after learning that Essure may be the cause of their horrific symptoms, thousands of women have had to undergo surgery to remove the micro inserts from their bodies. Because Essure is permanent, and cannot be reversed, removal of the coils is usually achieved by way of a partial (removal of the uterus), or total (removal of the cervix and uterus), hysterectomy. Depending on the patient, additional surgery, such as, a salpingectomy (removal of the fallopian tubes) or a salpingo-oophorectomy (removal of one or both ovaries, as well as one or both Fallopian tubes) may also be necessary. Additionally, the micro-inserts can break or move, and multiple surgeries may be insufficient to remove the device’s components. As a result, beyond the severe side effects reported after Essure implantation, removal of the device presents its own litany of side effects and complications.