Too much risk?
ANDREA MERKORD was three months pregnant when she got devastating news. Doctors told her that two of her triplets were sharing one heart and wouldn’t survive. If they died, the third fetus would likely die too.
So Merkord didn’t hesitate when doctors at UC San Francisco proposed an experimental surgery to try to save one of her babies’ lives. They would insert a small needle into her womb and use a laser to separate the two endangered fetuses from the healthy one. If the procedure worked, they said, it was possible they could save the healthy baby.
“It blows my mind we were able to do this. It was a godsend,” says the 31-year-old Bend, Ore., medical clerk, who now has a healthy 3-year-old son, Thomas.
Just a few years ago, fetal surgeries were rare and only a handful of top research hospitals, such as UC San Francisco and Children’s Hospital Boston, performed them. That is quickly changing. Six fetal centers have opened across the country in the last four years and as many as 10 other hospitals are considering similar programs, according to several experts. UC San Diego performed its first fetal surgeries earlier this year. Meanwhile, doctors are expanding the type of fetal conditions they are willing to treat. Until recently, doctors typically have intervened only when a fetus’ life is at stake because of the risk to both the woman and the fetus. Today, however, more hospitals are performing fetal surgeries in cases where the fetus is not endangered. One new intervention, for example, involves using a laser to cut away relatively common obstructions around a fetus’ growing limb, a potentially difficult but clearly non-fatal condition. Doctors also are considering surgeries to repair cleft palates and other cosmetic procedures.
As more hospitals enter the field, a debate is growing among doctors, researchers and medical ethicists. Critics point to a paucity of research about the safety and effectiveness of such procedures; until more studies are done, some are calling for stricter limits. Among their chief concerns: Smaller hospitals with fewer resources and less-experienced physicians are performing the procedures.
Critics say that may increase the risks associated with such surgeries. Several doctors said they are aware of three cases worldwide in which both the woman and her fetus died during surgery. The majority of women who undergo fetal procedures have premature labor, increasing the risk of death for the unborn child. The woman’s uterus can rupture, which can require a hysterectomy, or she can have such severe scarring from surgery that she may have trouble conceiving again. And up to 5% of children who are born premature following fetal surgery develop cerebral palsy, doctors said.
In 2000, a woman died while undergoing a procedure to reverse a complication involving her twin fetuses. The incident in Florida was the first known maternal death during fetal surgery in the U.S. The surgeon who performed the surgery believes that the woman died from an amniotic fluid embolism after fluid leaked into her body and sent her into shock; both fetuses also died. Lisa Patterson, a spokeswoman for St. Joseph’s Women’s Hospital in Tampa, said the hospital settled a lawsuit with the family and declined further comment about the incident. She said the hospital believes its fetal program is safe and that complications are rare.
Dr. Edmund Yang, director of Vanderbilt University’s Fetal Diagnosis and Therapy Center in Nashville, said he is confident that many fetal surgeries offered today will eventually be proved safe and effective. But Yang said the Florida case, as well as reports of medical complications during fetal surgeries elsewhere in recent years, have caused some physicians to rethink which surgeries are appropriate and which are not. This fall, Yang and a group of two dozen surgeons will meet in Dallas to discuss creating national standards for fetal procedures.
“Because of the proliferation [of the surgeries] and the risks, we need a better consensus about what we’re doing among doctors, researchers and patients so that people don’t get hurt,” Yang said.
Because there is no national registry for fetal surgeries, no one can say how many procedures have been performed or their medical outcomes. In interviews with more than a dozen fetal surgeons, they estimated that 400 to 500 procedures will be performed this year at 15 hospitals. As more centers open, doctors predict a few thousand women a year could eventually be candidates for maternal-fetal surgery.
Doctors at UC San Francisco successfully performed the first major fetal intervention in 1981, when they corrected a potentially fatal blockage to a fetus’ urinary tract. Doctors are now treating as many as 15 different conditions. Some operations involve “open” surgery, where doctors cut into a woman’s womb, partially remove the fetus and operate while it is still attached to the umbilical cord. Some newer interventions use a less invasive “fetoscope,” which is only slightly bigger than a large needle and has a small camera attached to help guide surgeons. Doctors believe fetoscopic surgery is safer, although there is little evidence that’s true so far.
Physicians recently have begun operating on fetal heart defects, an experimental procedure generally considered to be at the leading edge of fetal surgeries. Dr. Russell Jennings, director of Harvard’s Advanced Fetal Care Center, said the outcomes of about 60 heart surgeries performed at the hospital are encouraging but ambiguous. About 5% to 8% of the fetuses died. Although a significant number of surgeries resulted in normal hearts, others yielded only partial improvements. Doctors can’t be sure what the outcomes would have been if no surgery was undertaken. “There are still more questions than answers,” said Jennings, “but we believe this will eventually prove to be effective in many cases.”
Proponents of fetal surgery insist that many medical innovations -- open heart surgeries or organ transplants, for example -- contained a significant element of risk as doctors first tried to perfect the procedures. Many also maintain that this is the way medicine works: A small number of patients must agree to undergo experimental procedures so doctors can learn and improve their techniques for the benefit of future patients. Dr. Mike Harrison, who has performed several hundred fetal surgeries at UC San Francisco over the last two decades, said some procedures that once had only a 10% success rate are now effective more than half the time. Better ultrasound technology and MRIs are allowing doctors to more accurately predict which surgeries are likely to work and which ones not. (Harrison has also discovered a unique advantage to operating in utero: there is significantly less scarring than in surgeries done after birth.)
Still, critics say fetal surgery is unique because it involves the life of both the fetus and the woman, who isn’t necessarily at risk until she agrees to have fetal surgery. Moreover, although surgery can save some fetuses, a significant number of the babies are born with severe disabilities.
These ethical questions have prompted some doctors to propose that fetal surgeries be performed only as part of large, national clinical studies, which would have to meet federal guidelines about the reporting of results and disclosures to patients. (The National Institutes of Health is sponsoring one national trial to study fetal surgery for spina bifida, but those results aren’t expected for several years.) Many hospitals permit such surgeries as “innovative therapies,” meaning that doctors need not participate in clinical trials or publicly report patient outcomes, although some still do.
Susan Wolf, professor of law and medicine at the University of Minnesota who has advocated for limits on fetal surgery, worries that fetal centers aren’t doing an adequate job of explaining what they know -- and don’t know -- to patients. “What non-life-threatening condition would merit this level of risk?” she asked. “Should doctors or parents subject a fetus to serious risks for uncertain benefits?”
Five years ago, Vanderbilt University invited Wolf and other medical ethicists to review its program after the university came under intense criticism from patient advocates and doctors for overstating the benefits and downplaying the risks involved with some fetal surgeries. (The university said it has addressed those concerns and that all fetal surgeries now are overseen by an oversight committee.)
Chiori Kaneko of Los Angeles had surgery to treat her twin fetuses last year at St. Joseph’s Women’s Hospital. Kaneko said she doesn’t recall anyone telling her that a woman died during the same surgery at that hospital. Kaneko gave birth to two healthy boys last November, but said she would like to have been informed about the previous case. “If I had been aware of all that, I would have probably decided to do the same thing, but I certainly would have given it more thought,” she said.
Dr. Ruben Quintero, who performed the surgery in which the Florida patient died in 2000 and Kaneko’s, said in an interview that the hospital informs all patients about the risks of surgery but doesn’t necessarily disclose the outcome of specific cases.
UC San Francisco’s Harrison acknowledges that critics of fetal surgery have some valid concerns. Nonetheless, he believes the procedures represent one of the most promising areas of medicine today: “The fact is, by the time a child is born the die has been cast. With this, we’re starting to change that.”
