FDA Warns of Gynecology EquipmentMar 14, 2002 | AP
The government sent doctors an urgent warning Thursday that a manufacturer may not have sterilized numerous devices used in births, infertility treatments and other gynecology procedures — posing a risk of life-threatening injuries.
The Food and Drug Administration (news - web sites) said the potentially dangerous devices, made by A&A Medical of Alpharetta, Ga., were sold nationwide and in Canada, Egypt, Lebanon and Italy.
The FDA said it was urging A&A to voluntarily recall the devices. A message left Thursday with the company was not immediately returned.
"We're going to take the action necessary to make sure the products are taken off the market," FDA enforcement chief Larry Spears said.
Former company employees told the FDA that sterile and nonsterile devices had been shipped together in the same batches, and agency inspectors who visited the company facilities found evidence supporting the allegations, Spears said.
Nonsterile products used in gynecology products could cause infections that lead to infertility, miscarriage and even death, the FDA warned, saying the problem could date as far as back as 1999.
Spears said he has no reports of injuries linked to the devices, but noted that gynecologic infections are common and may not raise a doctor's suspicions. He could not say how big a supplier of gynecology devices A&A is.
Among the potentially dangerous devices are uterine dilators, endometrial sampling sets, fetal blood samplers, accessories used in minimally invasive gynecologic surgery, harvesting pumps used for in vitro fertilization, and bone marrow needles, the FDA said.