Doctors Must Notify Patients of Possible Unapproved IUDs
Eight doctors in Southern California have been instructed to send letters to more than 850 patients notifying them that the doctors are under investigation for allegedly illegally obtaining contraceptives from unlicensed vendors on the Internet or from Mexico, the Los Angeles Times reports.
Public Health Officer Mark Horton in a statement said, "The physicians under investigation have failed to provide proper evidence that shows they purchased federally approved [intrauterine devices] from FDA-approved sources." California physicians are required to purchase IUDs from licensed distributors in the U.S.
No specific health threat from the devices has been identified, but "[t]heir safety and effectiveness is unknown," according to Horton's statement.
Susann Steinberg, a state health official, said IUDs used abroad do "seem to be effective and safe in the countries they are used."
The physicians were ordered to notify all women who have received IUDs since Jan. 1, 2005, and the patients were advised to discuss with a doctor whether to leave unapproved devices in place.
The doctors' clinics are located in Alhambra, Downey, Glendale, Hemet, Los Angeles, Norwalk, Santa Ana and Van Nuys.
One doctor allegedly has refused to notify his patients as directed. The physician said that he has been notifying his patients about the devices but that the notification required by the state would imply he might have knowingly violated state and federal law. The doctor maintains that he believed he was purchasing IUDs from a legitimate source and that the devices had been approved by FDA.
The state will send notification to the 52 patients treated by that doctor. Health officials are seeking to suspend the doctor from receiving Medi-Cal and Family PACT payments. Medi-Cal is the state's Medicaid program (Lin, Los Angeles Times, 9/10).