Essure is a birth control device that was created as an alternative to the pill or tubal ligation, and for which no surgical incision or anesthesia is required. Following its FDA approval in 2002, Essure quickly grew in popularity as a low-impact, highly-effective form of birth control. Unfortunately, within about 10 years, thousands of complaints had been reported. Women claimed that serious side effects had forced them to have the device surgically extracted. Not surprisingly, a surge of lawsuits followed.
How Does Essure Work?
The Essure implant is composed of flexible coils that are inserted into the fallopian tubes using a non-surgical procedure. Once in place, the coils prompt tissue to grow around them, essentially “locking” the coils in place and blocking the fallopian tubes with the new tissue. As a result of this blockage, sperm is no longer able to move through the fallopian tubes, and thus cannot reach, nor fertilize, the eggs.
Once the three-month period has passed, women who have received an Essure implant are supposed to follow up with a radiologist to ensure that the tubes are fully blocked. In some cases, patients never reported for their three-month visit. A Boston defective medical products attorney can help you recover damages if you’ve been injured by an Essure implant.
Complications Linked to Essure Implants
According to the FDA, more than 5,000 women have reported problems with Essure implants since it was approved in 2002. The main issue with these implants seems to be that they were never tested for long-term use. Intended to be implanted for life, Essure was approved based only on a few short-term studies. Reported side-effects and medical complications include:
- Abdominal or pelvic pain
- Vaginal bleeding
- Rash or itching (may be caused by an allergy to metal nickel in the implant)
- Menstrual cycle changes
- Joint pain
- Ectopic pregnancy
- Unintended pregnancy
- Device migration
- Perforations or punctures in the fallopian tubes, uterus, or abdomen
- Multiple surgeries, including hysterectomy
According to the FDA, the agency had required that Conceptus conduct a follow-up study within five years of approval, to ensure that long-term use was safe. This should have occurred in 2007, but the results were not published until 2015. And even then, only about 70 percent of women with Essure implants had been followed for the required five-year period. Sadly, these types of delays are quite common in the medical device and pharmaceutical industries. Companies get quick approval for their drugs and devices by telling the FDA that they will conduct post-approval studies, and then fail to do what they promised.
Due to the testing delay, multiple complications were not detected until it was too late for many patients; the stainless steel in Essure implants can rust, the nickel can produce a dangerous oxide, and the implant can leak toxic byproducts. Further, the device can migrate to other parts of the body, resulting in life-threatening punctures and perforations.
There are currently hundreds of product liability and medical malpractice lawsuits against Essure’s manufacturer, Conceptus. Lawsuits claim that Conceptus failed to warn physicians, patients and the FDA about the known risk of abdominal injuries, among other complications. Had they known about these risks, plaintiffs could have chosen a different method of birth control. A MA injury attorney can help you determine how to move forward if you’ve been injured by an Essure implant, or any type of medical device. Continue reading