Hysteroscopic Sterilization with the Essure Device
Bayer HealthCare’s Essure device—a hysteroscopic sterilization implant—is at the forefront of lawsuits which allege that Bayer attempted to conceal information regarding the implant’s safety.
Sterilization is one of the most common forms of contraception for women throughout the world. In the United States alone, millions of women have undergone laparoscopic or hysteroscopic sterilization procedures as a means of providing permanent birth control.
In 2002, Bayer HealthCare received pre-market approval from the Food and Drug Administration (FDA) for its Essure device; a hysteroscopic implant method of sterilization that provided a less invasive alternative to other hysteroscopic procedures used. During the procedure, metal coils are implanted into a patient’s fallopian tubes. The theory behind the device is that over a period of time scar tissue would form around the coils, thereby blocking the ability for conception to take place. The Essure device amassed popularity with physicians and patients shortly after market introduction due to the fact that the procedure required less time and money, and the use of anesthesia was not required.
Over the past ten years, thousands of women have filed adverse effect reports with the FDA, detailing complications after receiving the Essure implant. The most common complications reported have related to severe pain in the pelvis, hemorrhaging and migration of the device within the uterus. Such effects have necessitated operation, and in some instances removal of the device. The effects caused by additional operations have led to ectopic and unintended pregnancies, which can be potentially fatal under certain conditions.
Reported side effects of the device include:
- Excessive bleeding
- Allergic reaction
- Pelvic pain
- Unintended pregnancy
- Ectopic Pregnancy
The number of women who have voiced concern about the device has grown substantially since 2005, leading Bayer to submit a request to the FDA to update the patient information associated with the device. The informational booklet now includes warnings of the risk of chronic pelvic pain and device migration. In September 2015, the FDA arranged an advisory panel meeting to discuss the risks and benefits of Essure, after numerous women called for the device’s withdrawal from the market.
2015 Studies Suggest Higher Risks
Research conducted between 2005 and 2013 assessed the risks of undergoing hysteroscopic sterilization by means of implants such as the Essure device, in comparison with laparoscopic sterilization surgery. Despite a previous belief that the hysteroscopic procedure was associated with higher risk of unintended pregnancy, studies concluded that while the risk of unintended pregnancy was similar to that related to laparoscopic surgery, the risk of reoperation related to the implant hysteroscopic procedure was 10 times higher than that of the alternative.
Further research revealed that despite marketing and sales claims that anesthesia use was unnecessary for the procedure, more than half of the patients who underwent the hysteroscopic implant procedure were given general anesthesia prior to the surgery.
Bayer became the subject of legal action pertaining to the device in 2014, when a woman filed suit on the basis that the implant procedure led to multiple hospitalizations, and ultimately her hysterectomy. The lawsuit alleges that Bayer violated the conditions upon which the device’s original manufacturer, Conceptus, initially received FDA approval. The plaintiff and her legal team also maintained that the company intentionally deceived consumers regarding the risks associated with the implant by concealing negative information that was released.
If you have experienced injury or suffering that could be related to implant based hysteroscopic sterilization, it is important that you consult with a medical professional. Further, if you have undergone reoperation, or experienced harmful side effects as a result of the Essure device, it is in your best interest to contact an experienced medical device liability attorney. For additional information or a no-cost consultation with one of our qualified attorneys, contact Peter Angelos Law today.