There they go again: Surgeons ‘innovate,’ but women patients get put at higher risk

hpvshot-300x231Women may need to double-up on their consultations with their specialists about treatment for serious gynecological concerns, as new studies have raised troubling questions about a much-touted minimally invasive surgery for early-stage cervical cancer.

These concerns, in a more perfect world, also would prompt greater questioning and oversight by doctors, hospitals, regulators, and lawmakers of surgical “innovations.”

The procedure now in question removes the uterus, part of the vagina, and other surrounding tissues via small incisions and with special laparoscopic instruments, including robots. Surgeons have advocated for this surgery rather than making a large incision in an “open” procedure, arguing the less invasive approach promotes less discomfort and faster healing for patients.

But prospective scrutiny of patients and retrospective data on them has shown that “the minimally invasive approach was more likely to result in recurrence of the cancer and death,” the New York Times reported, based on findings from two published studies. In the large, direct study of women:

After 4.5 years, 96.5 percent of the patients who had open surgery were free of cancer, as opposed to 86 percent in the minimally invasive group. At three years, 99 percent of the open-surgery patients were alive, compared with 93.8 percent of those who had minimally invasive operations. With a median follow-up time of 2.5 years, 27 patients in the minimally invasive group had a cancer recurrence, compared with seven who had open surgery. There were 19 deaths in the minimally invasive group (14 from cancer), and three in the open group (two from cancer).

The newspaper also noted that:

[These] results affect a relatively small number of women in the United States, where screening has reduced the incidence of cervical cancer to about 13,000 cases a year, with about 4,000 deaths. But worldwide, cervical cancer is the fourth most common malignancy and cause of cancer death in women, with 570,000 cases a year and 270,000 deaths. The disease is caused in nearly all cases by the human papillomavirus, HPV, an extremely common, sexually transmitted virus. In most people, the immune system clears the virus and they never knew they were infected. But in some it persists and can cause cervical cancer and other malignancies.

The patient study involved 631 women and 33 hospitals in the United States, Colombia, Brazil, Peru, Italy, China, Australia and Mexico. Investigators had hoped to involve more than 700 patients but experts overseeing the study stepped in, deciding that the higher death rates shown already needed to be disclosed and the research stopped.

The information already has resulted in a halt to minimally invasive surgery for early stage cervical cancer at Johns Hopkins and M.D. Anderson, which paid for the research with the medical-device maker Medtronic, the New York Times reported. Researchers emphasized that the company played no role in shaping the study and had no sway on its results.

Meantime, separate research on patient data, funded by the National Institutes of Health and a charitable foundation, has found, the New York Times reported, that:

In one analysis, 1,225 of 2,461 women had minimally invasive surgery, and the rest had open surgery. At four years, 9.1 percent in the minimally invasive group had died, compared with 5.3 percent who had open surgery. Another analysis looked at the survival rate for cervical cancer surgery over time and found that it began to decline when minimally invasive surgery was introduced, dropping by 0.8 percent a year after 2006.

Researchers are uncertain why the minimally invasive surgery’s results were poor, possibly because the “key hole” instruments themselves may spread cancer cells or the procedure may prevent surgeons from removing all the cancerous tissues they should. It may be that carbon dioxide, used to inflate the abdominal cavity to help surgeons see better during this procedure, may help lingering cancer cells flourish.

The results should provoke deep questions by doctors and hospitals. But will it?

In my practice, I see the harms that patients suffer while seeking medical services, including their struggles to afford, access, and fully understand the safety, effectiveness, and excellence of their increasingly complex medical care, filled with choices and uncertainties. The problems discovered with minimally invasive surgery for early-stage cervical cancer are but the latest of several.

It took a Wall Street Journal investigation to get surgeons to reconsider another destructive operation for women — the use of a grinding tool, a so-called “morcellator,” in hysterectomies. The device’s use had become widespread in yet another minimally invasive procedure before investigators showed that it spread cancer cells and the disease throughout patients’ bodies. The federal Food and Drug Administration only belatedly stepped in to warn against the device’s use, a caution it recently retained even as the agency is pushing to speed up its approval processes for medical devices at the industry’s behest.

Weight-loss surgeons, meantime, quietly have given the heave to lap-band procedures — too often performed on women — only after seeing how often they required follow-up work and failed to produce promised results. Uncle Sam, that being you and I as taxpayers, threw a half-billion dollars for seven years at this unacceptable operation.

These surgeries should concern not only women and raise issues as to whether surgeons have been too gung-ho to experiment with new techniques on them. The latest studies should get doctors, hospitals, regulators, and lawmakers to poke hard and anew at some hallowed and accepted practices, such as the minimal oversight of swash-buckling surgeons’ “innovations.” As the New York Times reported of these:

Surgery is not regulated the way drugs are. Although the Food and Drug Administration must approve new surgical devices, it does not control the way they are used. A tool approved for one purpose can be used for another. Surgeons can try new approaches, and innovations can catch on and spread, as long as hospitals allow it.

Here’s the catch, mentioned but less so in the newspaper article: Surgeons, in particular, and hospitals, especially, invest a lot of time, money, resources, and reputation in capacities — human- and device-based. Surgeons can build their renown and practice profitability by distinguishing themselves in purportedly performing operations in unique ways, even if these add to patients’ risks and costs.

In the face of glum data on minimally invasive procedures for early-stage cervical cancer, some surgeons quoted by the New York Times said they would persist with the operations because they have spent so much energy learning how to do them. They pledged to discuss risks with patients. Really?

Even after many experts joined the Wall Street Journal in its findings and morcellators fell out of favor, some surgeons continued to use them — please note that the FDA “warned” against the devices but did not ban them for minimally invasive hysterectomies.

Meantime, surgeons and big hospitals, especially, are making a booming business of robot-assisted surgeries (they provided, incidentally, a slice of data in the cervical cancer study). These devices, which cost more than $1 million each and are supposed to heighten surgeons’ minimally invasive and other operations, don’t pencil out. They cost patients more and can keep them in operations longer — all without demonstrable benefit. Younger practitioners have embraced the technologies, causing a surgical divide: Their older colleagues know how to perform the older, proven, and more invasive procedures, though they may not be whizzes on the robots. The younger surgeons, though, may not be skilled at un-assisted and sizable operations. What happens to a generation of practitioners if their gee-whiz gadgets and approaches turn out to be harmful and too costly for patients?

Vinay Prasad and Adam Cifu — physicians, researchers, and professors — are experts on “medical reversals,” situations that occur in medicine when overpowering new evidence emerges that causes practitioners to discard what they have been doing. This doesn’t happen enough, they warn.

Indeed. If nothing else, as surgeons claim to advance their practices, other medical experts need to follow more closely behind, conducting rigorous research to determine what really benefits patients and what does not. It’s tragic that modern medicine, violating an axiom of carpentry, would cut first, then measure. Patients, beware — and let there be no complaints if they seek remedy and justice in medical malpractice cases.

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