Study Questions Safety of Bayer's Female Contraceptive

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pregnancy-test-1412563-639x426For many years tubal ligation, more commonly known as "having your tubes tied," was the standard in permanent female contraception. Originally, the procedure was only used when medically necessary, for example when an additional pregnancy might put a women's life in jeopardy. Later, the technique emerged as an elective procedure for those looking to have more control over family planning. Then in the early 2000's an implantable device, called Essure, owned by Bayer, debuted as a safer alternative. But a recent study calls the safety claim into question.

The study, published in The BMJ, compared followup results from 8,048 women who had received the Essure implant, and 44,278 women who had underwent tubal ligation. The women were all from New York State, and underwent these procedures between the years 2005-2013.

Researchers found that women who had Essure implanted were 10 times more likely to have a re-operation during their one-year follow up, as compared to those that had the tubal ligation.

The FDA has also reported a high volume of complaints from women -- more than 2,200 last year and over 1,300 in the first half of this year -- who have had the Essure implant. Many have complained of severe, persistent pain and bleeding, and this despite the fact that Essure is highly endorsed by both Planned Parenthood and the American College of Obstetricians and Gynecologists.

The device is made of a flexible metal -- a nickel-titanium alloy -- and it's implanted in the fallopian tubes to cause local inflammation. This results in scar-tissue formation in the tube that creates a physical barrier to conception. The insertion takes about 10 minutes and it can be done in a physician's office.

In contrast, tubal ligation is a surgical procedure that requires anesthesia and carries other risks, such as possible damage to the bowel as well as post-op infections.

Both procedures boast an effectiveness rate of well over 99 percent at preventing future pregnancies. But given the choice between a 10-minute procedure and a major operation, it's easy to see the allure of Essure (or a similar device).

However, the striking results of this trial suggest that it may not be safer in the long run.