Bayer AG's Essure received tons of complaints from women who used it. Federal health regulators are now planning to warn women about using the contraceptive implant.
The Food and Drug Administration (FDA) announced that the device will carry a more serious type of warning to alert the consumers and the doctors. This came after reports of bleeding, chronic pain and other health issues, NY Times reported.
Many women petitioned to remove the device last year. However, the FDA stopped removing the device from the market and required Bayer to conduct more tests to see the device's risk to different groups of women.
"More rigorous research is needed to better understand if certain women are at heightened risk of complications," said Dr. William Maisel, chief scientist for the FDA's device center.
FDA stated that Essure is an "appropriate option for the majority of women," however, "some women may be at risk for serious complications." The device can damage the uterus or other organs once it shifts out of position.
Essure is consists of two small nickel-titanium coils. It is being inserted to fallopian tubes to alternate tubal ligation for permanent birth control. Once inserted, scar tissue will form around the device which prevents pregnancy, according to Reuters.
The FDA issued a checklist for the doctors to be able to discuss the risks with their patients.
"The agency continues to believe the product should remain available to women who are informed of the risks," Dr. William Maisel, deputy director for science in the FDA's center for devices and radiological health, told Reuters on a call.
There will be a post-market study that will have 2000 women who will be monitored for a minimum of three years. The study will compare Essure implant to tubal ligation, according to Maisel.
It is estimated that about 750,000 women around the world are using Essure and 70 percent of them are in the country.
