After a large number of complaints, the US Food and Drug Administration regulators will review a birth control implant called Essure.
The implant device was approved by the Food and Drug Administration back in 2002. It takes the shape of a metal spring conceived in such a way that it does not allow any egg to pass through it once it is places in the uterine tubes.
After multiple complaints from women who have said that they experienced irritating side effects, the FDA scheduled a meeting on Thursday where they will discuss whether the device is safe or not.
The agency have met with patients several years before to discuss the issues and experiences they got after the Essure implant. The FDA declared in a statement this week that they will continue to discuss with new patients why is that they are experiencing these side effects.
Bayer, the company that produces the implant, has acknowledged some possible side effects, such as pelvic pain, rashes, or the migration of the implant. However, women said that they have experienced much more side effects than those from the list. For instance, one Essure patient claimed that she felt a strong taste of metal in her mouth and experienced heavy bleeding, right after she got the device implanted.
The Food and Administration Program said that the number of complaints is alarming, with as much as 20,000 of them being shared only on social media sites. The agency reported that they has been a significant increase in the number of complaints about the Essure implant in the last couple of years. Bayer officials declared that they are currently looking at the issue and they appreciate the fact that the FDA wants to discuss the matter with them.
The company declared on Monday: “While there are risks with all medical devices and and procedures, Bayer’s highest priority is patient safety, and we sympathize greatly with any woman who has experienced problems with Essure.” Bayer promises that they will continue to listen to their patient’s questions and suggestions when it comes to Essure. The company state this week that the devices was tested on 10,000 women before it was approved on the market by the FDA back in 2002.
There is the possibility that some women are allergic to the metal. The bad news for those women who already have the implant is that Essure is very difficult to remove once it is placed in the uterine tubes.
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