Federal regulators have sent a warning letter to a Chicago fertility doctor, citing his clinic’s failure to meet standards for screening egg donors for sexually transmitted diseases.
The U.S. Food and Drug Administration’s letter to Dr. Martin Balin was posted on the agency’s website Tuesday night. FDA spokeswoman Lisa Misevicz said nobody got sick, but the FDA’s goal is to “prevent anyone from becoming sick in the future.”
The letter followed an FDA inspection of Balin’s north Chicago office from June 20 through Aug. 17 during which an investigator found “significant deviations” from required screenings for egg donors.
The FDA routinely inspects clinics that deal with human tissue, including donated eggs, which can be used to help infertile couples conceive. Women generally are paid to provide eggs, which are retrieved and fertilized. The resulting embryos are implanted in the recipient’s uterus.
Balin’s office failed to meet screening standards for chlamydia, gonorrhea and HIV, according to the FDA letter.
Balin told The Associated Press that he has addressed the FDA’s concerns.
“I think the testing was not clearly the way they wanted it,” Balin said, adding that the women who received donated eggs were safe because they took required preventive antibiotics. He said that a lab that ran the wrong HIV test used another test instead.
“Patients were always safe, that I can tell you,” Balin said.
American Society for Reproductive Medicine spokesman Sean Tipton said it’s very important to screen egg donors. Tipton also said his group’s standards match the FDA’s standards.
The president of an affiliated group said the risk of spreading disease through fertility treatment is very low.
“There’s never been a reported case of any kind of disease transmission from egg donation,” said David Ball, president of the Society for Assisted Reproductive Technology and lab director of Seattle Reproductive Medicine. Screening is “a federal mandate so we have to follow it.”