Choosing Between Essure or Tubal Ligation
For many women seeking a permanent form of birth control find themselves asking if they should have Essure or tubal litigation. Both have a lot of dangers involved, however, many women do not know exactly how dangerous Essure really is. It is so hazardous other countries have banned the device; however, it is still legal to sell in Essure.
About Tubal Ligation
Tubal ligation is colloquially known as having your tubes tied. It is a type of permanent birth control. During the procedure, a doctor cuts, ties or blocks the fallopian tubes to permanently prevent pregnancy. This prevents an egg from traveling from the ovaries through the fallopian tubes and blocks sperm from traveling up the fallopian tubes to the egg. Doctors usually cannot reverse a tubal ligation.
Essure is a soft, flexible metal spring made from a nickel-titanium alloy. Doctors offer it to women as an alternative to the invasiveness of tubal ligation. Essure typically involves general anesthesia and a laparoscopy in the doctor’s office unlike a tubal ligation, which occurs in a hospital and requires surgery. A doctor inserts one Essure coil into each fallopian tube. Scar tissue will form around the coil to obstruct sperm from fertilizing an egg in the fallopian tubes. Three months after the procedure, women must have a follow-up procedure involving an X-ray and dye to confirm that the tubes are fully blocked.
Choosing Between Essure or Tubal Ligation
JAMA published a new study comparing the risks of choosing either Essure or tubal ligation. The study found that Essure brought a higher risk of gynecological complications. The study looked at data on 105,357 women who underwent an Essure or tubal ligation procedure between January 2010 and December 2014. Doctors performed the procedures in 831 hospitals.
Researchers found Essure to be more dangerous. In fact, almost 5% saw a failure rate after one year. That rate jumped to almost 6% after three years. Women with a tubal ligation had a less than 1% failure rate.
The FDA fast-tracked approval of Essure in 2002 with the requirement that researchers will monitor patients in the initial study for an additional 5 years. Regrettably, researchers followed only 366 of the original 618 patients. Out of those 366, 15 had hysterectomies, 38% had usually heavy periods, 5% suffered from recurrent pelvic pain and 4% painful intercourse.
The FDA received over 10,000 reports of injuries and 30 deaths from the device. This is just the small amount actually reported to the agency. Statistics have shown that many neglected to report adverse events to the FDA. The FDA only approved the device on the premise that Bayer completes a 3-year study following over 2,000 women with Essure. However, the company never completed the study. If they did, they would have known that their supposedly 100% safe device, in fact, had an 11% failure rate.
Increased Risk of Surgery
The whole point of choosing Essure is to avoid invasive surgery. However, in 2015, the British Medical Journal published a study linking Essure with a 10-fold risk of needing follow-up surgery. Researchers compared Essure to tubal ligation. Researchers based their conclusions on an analysis of over 50,000 women in New York. Doctors sterilized these women between 2005 and 2013. During this time, 2.4% of Essure users needed additional surgery versus 0.2% of those who had laparoscopic sterilization. Additionally, this equated to about 10,000 women needing additional surgery after having Essure.
We Want to Help Essure Victims
Furthermore, it is your right for manufacturers to inform you about the long-term risks associated with the medical devices, and it is the responsibility of manufacturers to provide this information. If you or a loved one has suffered any side effects from Essure, you should demand accountability from Bayer. Why did no one tell you?
Of course, we want to help send a message that this is not acceptable. We are advocates for consumers who have been harmed by dangerous products, and likewise, we have the experience necessary to successfully litigate these cases.
Contact the Michael Brady Lynch Firm today for a free consultation to learn more about seeking justice. Compensation may be available for any medical expenses associated with this ordeal, as well as for your physical and emotional suffering. There is no obligation.