Adhesive tape and red tape: the strangling of surgical innovation in America.

• Author: Detmer, Don E.

". . . What is needed is a balancing of innovation with a number of other legitimate public policy objectives such as safety, access, high quality, and cost-effectiveness."

SURGICAL INNOVATION--the advancement of technique, technology, and practice through the creative application of research--plays a key role in medical progress. Most Americans are aware of what it has accomplished--coronary artery bypass grafts, liver transplants, hip and knee replacements, laser excision of solid tumors--and understand the hope it represents for human health.

Yet, just how does surgical innovation come about in the labyrinthine world of contemporary American health care? What allows it to flourish? What threatens it? What is the outlook for surgical research as we approach the 21st century? From the vantage point of the early 1990s, prospects appear decidedly mixed, especially in view of current trends in society as a whole and in health care practice, financing, and policy. Skeptical and increasingly restrictive attitudes and actions toward the medical profession and biomedical research abound, despite intensifying demands for more and better care and innovations in a world beset by environmental, socioeconomic, and technological health hazards. We should view these circumstances with some concern and, in response, must develop an agenda for promoting research and innovation in surgery.

The dominant trends in surgical practice today, drawing on the advances of the last two or three decades, involve ever greater technical sophistication and less and less physical intrusion upon the patient. How the surgeon goes about his or her work is changing dramatically. In terms of the invasiveness of the technology itself, surgeons are engaged in a "high-tech/low-touch" enterprise. Impressive improvements in technology and technique require them and their teams to possess exceptional technical sophistication, which enables them to work with great precision while subjecting the patient to a minimum of bodily insult.

The implements of high-tech/low-touch surgery include laser devices, flexible fiberoptic scopes with astonishing visual resolution and tissue specimen retrieval capabilities, clever stapling devices, high-resolution operative microscopes, and instruments that function through small hollow trochars passed into the body through tiny incisions. For example, using specially equipped flexible laparascopes, gallbladders routinely are removed through half-inch openings in the abdominal wall. Such high-tech equipment and techniques significantly can reduce the risks, recuperation time, and costs associated with some major operations. Procedures that even two years ago required the patient to be in the hospital for a week and out of work for three to four weeks, at significant expense, now entail only an overnight stay and just a week's absence from the job, at a fraction of the prior cost.

Biomedical research in general and surgical innovations in particular over the last 30 years have revolutionized surgical practice, even to the point of redrawing boundaries between general surgery and subspecialties. A number of problems for which surgery was the accepted treatment and the surgeon the requisite specialist now are managed in a nonoperative and minimally invasive manner. For example, urologists use sound waves generated by lithotripsy machines to pulverize kidney stones. Effective medications like Tagamet and Zantac have brought about the virtual disappearance of surgery as treatment for peptic ulcer disease. Benign prostatic hypertrophy is likely to go the way of medical treatment, too, so that surgical care for this common malady of older men soon may be limited to periodic dilatations. Long-acting anti-fertility measures based on hormonal control or immunologic response promise to make birth control safer and far more effective. Gynecologic surgery associated with fertility essentially could disappear in favor of medical management, unless social reactions to new birth control technologies stop such progress.

There are a host of new frontiers in surgery today. For example, high-tech gynecologic procedures such as fallopian tube dilation may restore female fertility, while in vitro fertilization and gamete intrafallopian transfer techniques successfully can circumvent infertility and allow women previously unable to do so to bear their own children. High-tech maxillofacial surgery relies on computers for assistance in remaking the faces of persons born with major bone and tissue abnormalities. Computer imaging allows plastic surgeons to model a person's postoperative facial appearance at different stages throughout the procedure, yielding better cosmetic results and even reducing the need for further surgeries. New open-heart surgery techniques can correct abnormalities in the heart's electrical conduction system (arrhythmias), disturbances that can be fatal or chronically disabling.

Neurosurgery is a field experiencing exceptional development. While the 1950s and 1960s were the era of heart surgery and the 1970s and 1980s saw the rise of transplant/implant surgery, the 1990s will belong to the neurosurgical sciences. The nervous system--brain, spinal cord, and peripheral nerves--is the final frontier in the organ-based medical paradigm that has driven surgical thinking throughout this century. Important breakthroughs allow us to treat those disorders of the brain which previously were untreatable or incompletely controlled medically. For instance, more precise techniques for mapping...