A new study found that women implanted with the contraceptive device Essure were 10 times as likely to require additional surgery within one year as those who had chosen tubal ligation. This only adds to concerns about the device. The U.S. Food and Drug Administration (FDA) received 2,259 complaints about Essure in 2014 and another 1,363 in the first half of this year. The agency is now being criticized for its failure to require a randomized and controlled study before approving the device.
Essure vs Tubal Ligation
Essure and tubal ligation are both used for permanent sterilization. Both work by closing off the fallopian tubes so eggs cannot travel to the uterus. In tubal ligation the tubes are blocked surgically with the use of a clamp, cauterization or removal of a portion of the tubes. Tubal ligation is effective as soon as the procedure is performed.
Essure is a tiny spring-like device, placed in the tubes through the vagina, rather than through an incision. The coils embed in the walls of the fallopian tubes, causing irritation and the development of scar tissue that blocks off the fallopian tube. It typically takes about three months for enough scar tissue to develop to completely close off the tube.
Tubal ligation is a minimally invasive procedure. One of the main marketing points of Essure was that it can be implanted nonsurgically in a 10 minute procedure without the need for anesthesia, but the study, published in the BMJ in October, 2015, found that general anesthesia was used in about half of the Essure procedures.
Essure Side Effects and Complications
The study found that women with Essure were 10 times as likely to require additional surgery due to problems with the device. Side effects and complications of Essure can include:
- Allergic reaction to the nickel in the device
- Pelvic pain
- Painful intercourse
- Migration of the device to other organs
If you have suffered one of these side effects after implantation of the Essure device, you should speak with an experienced defective medical device attorney as soon as possible.