New Sterilization Procedure Can Be Done Without Abdominal Incision
Adam Savakus, vice president of regulatory and clinical affairs at Adiana, tells WebMD that pivotal human trials are expected to begin in the U.S. by the end of 2002. "We already have about 30 women who have participated in safety studies," he says.
Stewart says that all the safety studies are done in women who are scheduled for hysterectomy. "The pivotal studies will be a trial of the procedure for elective sterilization," he says.
Kathleen Fitzgerald, MD, a clinical assistant professor at Brown University in Providence, R.I., says that she isn't sure that ob-gyns will be willing to do sterilization procedures in their offices. Office-based procedures, she says, require special anesthesia machines for administering conscious sedation as well as specially trained staff. She says that many ob-gyns may find the cost prohibitive.
But she says that a safe sterilization that could be done without making an abdominal incision would be a major advance. "When I was trained we used to do vaginal tubal procedures, but we stopped doing them because we had a lot of infections and failures," says Fitzgerald. She says that ob-gyns are interested in any procedure that can "avoid an incision into the abdomen."
Fitzgerald says that the procedure, if it passes FDA muster during clinical trials, may be a good option for women who have had multiple abdominal surgeries or women who are obese. In both cases "laparoscopy (working through a scope placed through the abdomen), which is now the gold standard, can be difficult."
Because sterilization is a more difficult procedure in women than vasectomy is for men, Fitzgerald says "I often ask couples if the man is willing to have a vasectomy because that is easier. But this procedure, if it gets approved, may make vasectomy and tubal ligation more comparable."