For many years, women who sought a permanent form of birth control were forced to undergo surgical sterilization procedures, an invasive process that required weeks of recovery. When patients heard of a new device that could prevent pregnancy and could be implanted in one clinic visit, they understandably saw it as an easier and more convenient option. But the device, known as the Essure System, caused many women to suffer painful and even irreversible side effects.
Side Effects, Injuries, and Complications Caused by Essure Implants
The Essure implant is a small wire coil that is placed inside the patient’s fallopian tubes. As scar tissue grows along the device, the entrance to the ovary is blocked off, preventing ovulation. While the device has worked without incident for some patients, the FDA received a number of reports of adverse events in women with the Essure device, including:
- Unintended pregnancy. Many women suffered accidental fertilizations after implantation with the Essure device, a risk that was greatest in the first three months after implantation. These pregnancies were not only unplanned, they were also more likely to occur inside the fallopian tube (ectopic pregnancy).
- Perforation. A recent New York Times article called attention to the dangers of Essure, citing a safety trial completed in 2003. Of 269 women aged 23 to 45 who received Essure devices, nine of these patients suffered perforation of the fallopian tube from the Essure coil, expulsion of the device, or suffered pain as the device migrated to somewhere else in the body,
- Complications leading to hysterectomies. Patients who suffered pain, bleeding, migraines, or perforation of the fallopian tubes or organs may not be able to have the device removed without damaging the uterus or other tissues. The only option in these cases is a complete hysterectomy, which can cause a number of unpleasant effects such as incontinence, pelvic organ prolapse, bowel dysfunction, and sexual difficulties.
- Pelvic pain. Women have reported severe cramps, painful intercourse, vaginal infections, back pain, and heavier periods or abnormal bleeding after being implanted with Essure. Bleeding is a dangerous complication of the device, since receiving the Essure system can prevent a patient from undergoing certain electrosurgical procedures. If a patient with Essure suffers uncontrollable uterine bleeding, she may be forced to undergo a hysterectomy.
- Deaths. Although rare, there have been some deaths attributed to side effects of the Essure implant. At least four women have died as a result of complications of Essure, most commonly as a result of infection and uterine perforation.
FDA Orders More Information About the Essure Implant
The FDA originally approved Essure in 2002 with the understanding that patients involved in the original trials would continue to be monitored for a further four years. Of the 269 women in the study, only 171 women were followed for the full five years of the study. Twelve of these women underwent device removal and five had hysterectomies. Although the device has not been recalled, the FDA ordered Bayer in February 2016 to complete a post-market surveillance study to gather reliable data about the benefits and risks of the Essure implant.
If you or someone you love has suffered an unintended pregnancy, excessive bleeding, or hysterectomy after receiving an Essure implant, you may be owed compensation. Our dangerous medical device law firm has been fighting for the rights of injured consumers for over 25 years, helping them hold companies accountable for causing irreversible injuries. We can listen to your story and help you recover financial damages for the pain you have suffered, including the costs of hospitalization, lost time from work, future disability, and pain and suffering.
The McGartland Law Firm has recovered millions of dollars in verdicts and settlements for victims, and we do not charge legal fees unless we are able to recover a settlement. Call or email our firm today to speak with a medical device lawyer about pursuing a case against a negligent company.