The Essure system was supposed to be a convenient form of permanent birth control for women. The device is an implant that does not require surgery and can be inserted during a regular doctor’s office visit, making it an attractive option for women who do not want to undergo sterilization surgery. But now, women are claiming that the Essure implant caused injuries and unintended pregnancies that led to avoidable surgical procedures.
Common Complications From Essure Hysteroscopic Implants
The Essure system inhibits fertilization by blocking the patient’s fallopian tubes, encouraging scar tissue to grow along the implant and effectively seal the entrance to the ovary. Over 750,000 patients have received the device in the years since the procedure was approved by the FDA. In that time, hundreds of unintended pregnancies and other complications have been reported by Essure patients. If you or a loved one suffered harm from an Essure implant, call the number on this page to speak with one of our representatives today.
Safety concerns with the Essure hysteroscopic implant include:
- Unintended pregnancies
- Incomplete procedures
- Tubal blockage occurring on only one side
- Perforation of the uterus or fallopian tubes from movement of the device
- Pelvic pain
- Intractable pain and bleeding leading to hysterectomies
- Possible device-related deaths
Women who suffer complications due to the Essure implant may require surgical removal of the device. If the implant cannot be removed on its own, women may suffer the loss of a fallopian tube, ovary, or even the uterus itself (hysterectomy), forcing a woman to undergo early menopause and causing unnecessary distress.
FDA Safety Updates and Claims Against the Manufacturer
The Food and Drug Administration (FDA) updated its safety guidelines for the Essure implant in 2016, acknowledging that some women could be at risk of serious complications. The FDA reported that the risk of unintended pregnancy is greatest in the first three months after the Essure system is implanted, and that ectopic pregnancies in these women are more likely to occur. An ectopic pregnancy occurs outside the uterus or inside a fallopian tube.
Patients who have the Essure system implanted may also be prevented from receiving pelvic electrosurgical procedures in the future, prohibiting them from receiving necessary or lifesaving care. For instance, patients with Essure cannot undergo some forms of endometrial ablation to stop excessive bleeding, causing complications that increase the likelihood of hysterectomy.
Women who have been harmed by the implant are making a number of claims against the device manufacturer, placing blame on the company for using unethical marketing practices and failing to provide accurate pre-marketing study results. Others have alleged that information from clinical trial testing was biased or incomplete, and that company researchers failed to complete follow-ups with patients that could have identified risks and prevented further harm.
Get the Compensation You Deserve for an Essure Implant Injury
Patients have a right to be informed of all potential risks of a medical device, as well as to undergo as safe and effective a procedure as possible. If you had an unintended pregnancy or were otherwise harmed after undergoing an Essure sterilization procedure, our dangerous medical device law firm can help you recover financial damages for your medical bills, loss of income, and pain and suffering.
The McGartland Law Firm has been holding companies accountable for failing to protect consumers for over 25 years, recovering millions of dollars in verdicts and settlements for victims just like you. We take all medical device cases on a contingency-fee basis, meaning you will owe us no fees unless we win your case. Call us today or send us an email to tell us about the problems you have endured.