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CDC HIV/AIDS/Viral Hepatitis/STD/TB Prevention News Update

ILLINOIS: FDA: Fertility Doctor Didn't Test Donors for STDs




 

SFGate.com (11.07.12)

The US Food and Drug Administration (FDA) has sent a warning letter to Dr. Martin Balin, a Chicago fertility doctor, citing his clinic’s failure to meet standards for screening egg donors for STDs. On November 6, the FDA posted the letter to Dr. Balin on their website. FDA spokesperson Lisa Misevicz noted that nobody got sick, but the FDA’s goal is to “prevent anyone from becoming sick in the future.” The FDA wrote the letter after inspecting Balin’s Chicago office during June 20 through Aug. 17, 2012. During that time, an investigator found “significant deviations” from required screenings for egg donors. The FDA inspects clinics that handle human tissue, including donated eggs, which can be used in assisting infertile couples to conceive. Females are usually paid to provide the eggs, which are retrieved and fertilized. The subsequent embryos are implanted in a recipient’s uterus. The FDA letter noted that Dr. Balin’s office did not meet the screening standards for gonorrhea, chlamydia, and HIV. Balin told the Associated Press on November 7 that he has addressed the FDA’s concerns. He stated, “I think the testing was not clearly the way they wanted it.” Balin declared that the women receiving the donated eggs were safe because they took required preventive antibiotics. “Patients were always safe, that I can tell you,” explained Balin. He added that a lab that ran the wrong HIV test used another test instead. Sean Tipton, spokesman for the American Society for Reproductive Medicine, noted that it is imperative to screen egg donors and that his organization’s standards are the same as those of the FDA. David Ball, president of the Society for Assisted Reproductive Technology and lab director of Seattle Reproductive Medicine, declared that, “There’s never been a reported case of any kind of disease transmission from egg donation. He added that screening is “a federal mandate, so we have to follow it.”



 


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