New Study Finds Essure Leads to Higher Risk of Surgery
A study was recently published that found that the Bayer Essure might lead to a higher risk of surgery.
Details of the Essure Study
According to Reuters, the Bayer AG Essure is a permanent contraception device that consists of two small nickel-titanium coils. The device is inserted into the fallopian tubes during a minimally invasive surgery. Afterwards scar tissue forms around the device, preventing the female from unwanted pregnancies. The device was approved for use in 2002. Bayer acquired the device in 2013.
The FDA called an advisory panel to discuss the benefits and risks of the device, deeming it a high priority issue, citing more than 5,000 events related to the Essure (note: it is unsure whether or not the Essure is the fault in any case).
The study published last week found that recipients of the device were more than 10 times more likely to undergo a post-procedure surgery than those who received the more common form of permanent contraception, laparoscopic sterilization.
Listed below are some of the key findings in the study:
- The study analyzed data on medical records of about 52,000 women from surgical centers in the state of New York from 2005 to 2013.
- Within one year after undergoing surgery, 2.4 percent of Essure patients needed another surgery. Only .2 percent of laparoscopic sterilization patients required a follow up surgery.
- This is about 21 additional surgeries per 1,000 patients.
- Both methods were about as equally effective, only showing a 1 percent chance of unwanted pregnancies.
- In some instances, the follow up surgeries are major, including hysterectomies.