Friday, September 25, 2009

Essure Complaints

Women should use condoms until they receive confirmation their tubes are blocked with Essure.


Essure, a permanent form of birth control approved by the FDA in 2002, is a procedure where your doctor places flexible inserts into your fallopian tubes during an office visit. Within three months after the procedure, as the tubes heal, scar tissue builds up that prevents sperm from reaching your eggs. Essure offers many benefits over other birth control methods, and althought Essure is considered quite safe, like any procedure, it presents the risk of possible complications and side effects.


Bleeding








Many women experience bleeding after the Essure procedure. A 2003 study in "Obstetrics & Gynecology" found that 50 percent of women bled for three days afterwards, and 19 percent had bleeding that continued for seven days. Most post-procedure bleeding was light or just spotting. Some women noticed changes to their menstrual periods --- usually temporary --- where their periods became longer or heavier, or they experienced mid-cycle spotting or bleeding.








Pain


During the actual Essure procedure, the manufacturer states that most women experience mild to moderate pain. A 2009 study in "Fertility and Sterility" supports this statement, finding that 70 percent of women felt that the discomfort from the procedure was less than or equal to the pain they normally felt with their menstrual periods. However, some women experience more severe pain. In clinical trials for Essure, the manufacturer found that out of 745 women, a "very small number" reported significant pelvic pain, and one woman requested the inserts be taken out because of the pain. During the 15 months after the procedure, 9 percent of women experienced back pain, 3.8 percent experienced abdominal pain and 3.6 percent experienced pain during intercourse that might have been caused by the inserts.


Misplacement


Fourteen percent of the women in Essure's clinical trials failed to get both inserts placed correctly during the first attempt. Another 2.2 percent of women expelled the inserts; in 1.8 percent of cases the insert punctured the uterus or tube; and in 0.6 percent of cases, the inserts ended up in the wrong place in the tube or outside of it. A 2009 study in "Fertility & Sterility" found that three of 100 women undergoing the Essure procedure ended up with misplaced inserts. In each case, the doctor had difficulty placing the inserts, suggesting that difficulties with the initial procedure increase the likelihood that the inserts will end up in the wrong place.


Pregnancy


No birth control method is 100 percent effective, and Essure is no exception. Women who have undergone the Essure procedure need to use a secondary birth control method for the first three months until a follow-up test confirms that the inserts have successfully blocked their tubes. In the clinical studies, 3.5 percent of women did not have fully blocked tubes at three months and needed a follow-up test at six months. A 2007 study in the "Journal of Minimally Invasive Gynecology" found that 64 out of about 50,000 women became pregnant after the procedure. In most cases, the women failed to follow the guidelines for proper follow-up after the procedure.

Tags: percent women, after procedure, birth control, Essure procedure, found that, three months, women experience