The US Food and Drug Administration (FDA) has ordered Germany’s Bayer to provide important information about the risks associated with birth control device Essure.
Essure is a permanent form of birth control, which involves the insertion of flexible coils through the cervix and vagina into the fallopian tubes.
The agency has taken this action to help women and their doctors better understand about the potential complications associated with implantable forms of sterilization.
Bayer has also been ordered to carry out new and mandatory clinical study for Essure to determine increased risks for specific women.
The company has to develop and conduct a post-market study, which will provide data to help the agency to better understand the risks associated with Essure and compare them to laparoscopic tubal ligation.
In addition, the FDA has ordered the firm to change product labeling, including a boxed warning and a patient decision checklist.
FDA Center for Devices and Radiological Health chief scientist and science deputy director William Maisel said: "The actions we are taking today will encourage important conversations between women and their doctors to help patients make more informed decisions about whether or not Essure is right for them.
"They also reflect our recognition that more rigorous research is needed to better understand if certain women are at heightened risk of complications."