U.S. regulators have announced that they will be reviewing a popular birth control implant called Essure. The implant first received approval from the Food & Drug administration back in 2002. The initial tests to approve Essure involved more than 10,000 women.
Essure works by blocking the fallopian tubes and preventing eggs from passing into the uterus. Essentially, a small spring is placed in the fallopian tubes themselves. The contraceptive was once popular due to its ease of use but now numerous women who used the device are reporting debilitating side effects.
Essure is produced by Bayer. The company has acknowledged that their device could potentially be migrating, causing pelvic pain, and other side effects. Some of the other side effects include a metallic taste in the mouth, tingling limbs, and itchiness. Many of the side effects were not initially listed on Essure.
Essure is made of harmless materials, including polyester, nickel-titanium, and stainless steel. At the moment it remains unclear why so many people are reacting negatively.
The number of complaints is no small matter either. The FDA reports that it found approximately 20,000 complaints made by women on Facebook and Twitter. The FDA also notes that the number of complaints has increased rapidly over the past two years.
Essure has been preferred by many patients and doctors alike because it offers a reversible but permanent way to prevent unwanted pregnancies. Unlike pills and other methods of birth control, patients do not need to remember to take their medication. Once the Essure device is in place, pregnancies will be prevented until the device is removed, though in some cases the Essure may migrate and no longer be effective.
The initial procedure to install the device takes only about 10 minutes and can be performed in a doctor’s office. While Essure can be placed in the fallopian tubes without surgery, surgery is required to remove the devices.
The ease of use for the devices has made the product very popular, however, many women have reported complications after having the Essure devices installed.
Essure has been a building controversy since 2013, but the FDA is only now acting on it. Still, Essure as remained popular due to its 99.74 percent success rate and the fact that it doesn’t affect hormone levels. Proponents of the device note that it can effectively reduce unwanted pregnancies.