"Current labeling is very benign. You can't limit hypersensitivity warnings to nickel allergy," said panelist Donna D. Baird, Ph.D., of the National Institute of Environmental Health Sciences in Research Triangle Park, N.C.
Several panelists said that there should be an official, check-box disclosure form for Essure, to make sure patients are fully aware of potential problems and other sterilization options.
On the physician side, panelists agreed that doctors should not insert the Essure device unless they have a plan already in place – and funded – to remove it. Device labeling should also tell doctors that if Essure doesn’t slip into the fallopian tube relatively easily, to abandon the procedure because difficult placement is likely a sign of trouble, the panelists concluded.
"If you don't have access to someone who can remove it, I don't think you should be implanting it," said panelist Cynthia Chauhan, a consumer representative from Wichita, Kan.
The FDA is accepting public comments on Essure until Oct. 24.
*This story was updated 10/2/2015.