The Introduction of No-Scalpel Vasectomy in the United States (1988-1992)
Libby Antarsh and Shelby Marston-Ainley
Five years after its introduction into the United States, the no-scalpel approach has gained a foothold in the performance of vasectomy by urologists and family practitioners. This paper describes how a series of stages involving doctors, professional journals, the media, and the public has encouraged the technique's acceptance.
In 1988, the Association for Voluntary Surgical Contraception (AVSC) [In 1994, the Association for Voluntary Surgical Contraception changed its name to AVSC International.] decided for several reasons to support the introduction of no-scalpel vasectomy in the United States. First, the procedure seemed to be a substantial technical improvement over incisional vasectomy. Studies in China had shown that it results in fewer complications than standard vasectomy (Li et al., 1991), and the technique promised to be less intimidating for clients (Program for Appropriate Technology in Health, 1988). Second, the no-scalpel approach might kindle interest in vasectomy for clients and for physicians, thus widening access to this contraceptive method. Third, the U.S. introduction might teach AVSC something about how to introduce the technique overseas, and demonstrate to developing world authorities and physicians that we were advocating nothing for them that we were not doing at home.
Although the technique did seem to be an improvement, AVSC had to overcome a number of obstacles. To begin with, we had limited funds and little experience in introducing medical technology in the United States; our experience overseas was mainly with governmental and nonprofit organizations, not with physicians in private practice. Thus, it was necessary to get endorsements for the technique from recognized U.S. physicians, inform the medical community about the technique, devise ways to train physicians, and inform potential clientele about the technique.
THE NO-SCALPEL VASECTOMY TECHNIQUE
The no-scalpel vasectomy technique is a refined surgical approach to the vas deferens that uses a locally applied anesthetic block. It requires unique surgical skills, including the use and handling of two special instruments. Upon exposing the vas, however, the surgeon utilizes his or her preferred method of vas occlusion.
After administering local anesthesia, the surgeon pierces the skin over the vas using a dissecting forceps with two sharp points [Figure 1]. With this same instrument, the doctor gently stretches an opening just large enough to expose the vas, and lifts the vas out; the physician then holds the vas in place with a ringed clamp [Figure 2] and proceeds with the operation. The surgeon can use the same skin opening to reach the other vas. No stitches are required to close the tiny puncture. As noted, the vasa deferentia are occluded using the physician's preferred method.
The no-scalpel vasectomy technique has many advantages over incisional vasectomy. U.S. doctors report less injury to tissues, less bleeding, and fewer complications like hematoma and infection, because in puncturing the skin and then extending the opening, operators are more likely to push aside, rather than to cut, blood vessels (AVSC, 1991). Large-scale follow-up studies of Chinese men who have had no-scalpel vasectomies report low hematoma and infection rates (Li, 1989). Complication rates for the no-scalpel approach compare favorably with the incisional technique (Nirapathpongporn et al., 1990). Men may experience less discomfort during the surgical procedure because the local anesthetic creates a perivasal block in addition to numbing the incision site (Li et al., 1992). No-scalpel vasectomy may take less time than incisional vasectomy (Nirapathpongporn et al., 1990), although in one five-country study, doctors experienced in both techniques took slightly longer to perform no-scalpel vasectomies than conventional procedures (Family Health International, 1991). Men appear to be less fearful of a technique that does not cut into the scrotum (Antarsh, 1988). Special instruments minimize the need for many different and unspecifically designed instruments.
Dr. Li Shunqiang of the Chongqing Family Planning Scientific Research Institute, located in Sichuan Province, China, developed no-scalpel vasectomy in 1974. In China and almost everywhere else in the world, vasectomy took second place to female sterilization in the 1970s. Today in Sichuan, vasectomy procedures outnumber tubal operations by a ratio of five to one. This achievement is generally attributed to the development and popularization of new vasal sterilization techniques, especially no-scalpel vasectomy and percutaneous chemical vas occlusion. Both are considered especially acceptable because they eliminate the fear of the incision and because of their low complication rates (Li and Liu, 1990). In the rest of China, tubal occlusion outnumbers vasectomy by three to one, but largely because of Sichuan Province, over 10 million Chinese men have had a no-scalpel vasectomy.
In 1985, a team of international sterilization experts, sponsored by AVSC and invited by the State Family Planning Commission, observed the technique in China. The team members were Dr. Mahmoud Fathalla, Egypt; Dr. Phaitun Gojaseni, Thailand; Dr. Marc Goldstein, Dr. Douglas Huber, Dr. Jack Lippes, Keekee Minor, and Dr. John Sciarra, United States; and Dr. Mary Rauff, Singapore. After receiving training from Dr. Li Shunqiang in China the following year, Dr. Marc Goldstein of New York Hospital, Cornell Medical Center, performed the first no-scalpel vasectomy in the United States.
INTRODUCING NO-SCALPEL VASECTOMY IN THE UNITED STATES
AVSC faced a daunting challenge when it introduced the technique into the United States in 1988: how to persuade tens of thousands of private-sector vasectomists--urologists, family practitioners, surgeons--to learn a modification of a "minor" surgical technique, originating from a non-Western country. To do so, as a nonprofit organization, AVSC had to leverage a largely self-sustaining program. We followed a multiphase plan: to reach and train vasectomists, to inform the media and build demand among consumers, and to develop informational materials for consumers and training materials for doctors. We designed and tested strategies for each phase, then modified them as needed to overcome peculiarly American training constraints and other problems.
The plan was ambitious--to make no-scalpel vasectomy widely available as the preferred vasectomy technique in the United States, and to make vasectomy a more acceptable choice for American men.
REACHING AND TRAINING VASECTOMISTS
Over 30,000 urologists, family practitioners, surgeons, and other physicians perform vasectomies in the United States (Orr and Forrest, 1985). Not every vasectomy provider would learn the refined Chinese technique, which according to trained physicians, requires more skill than conventional vasectomy. By what criteria should AVSC select candidates? How could we reach potential trainees? How could AVSC persuade those who met the criteria to learn a technique unknown and unproven in this country?
The Science Committee of AVSC recommended beginning with academic urologists who would test the technique and whose involvement and support would make wider introduction easier. AVSC could gradually widen the physician base to include family practitioners, general surgeons, and residents, including doctors with less or no experience with vasectomy.
At first, we adopted the prevailing American teaching methodology of "see one, do one, teach one." Relying on local family planning organizations in California, Massachusetts, and New York to identify experienced vasectomists, AVSC organized one-day "orientation" seminars. Physicians listened to didactic lectures and reviewed slides and video demonstrations of the technique. Interested participants requested training materials and the unique instruments made in China that were needed to perform the procedure. As a condition of obtaining the instruments, the doctors submitted to AVSC periodic reports of their no-scalpel experience. An important factor in all this was Dr. Li Shunqiang's firm conviction that proper training was crucial; he gave AVSC control over instrument distribution because of his concern for adequate training.
After several months' experience, the first class of vasectomists reported mastery of the technique and improved outcomes for their patients. Almost universally, they abandoned their former method for the new one. An AVSC team observing their procedures, however, found that although these doctors had realized some advantages, they had not fully mastered the technique.
If the no-scalpel approach was to take hold in the United States, its early adopters would have to master it. Halfway adaptations or variations would deter the next generation from learning the essentials. And it appeared that providers could not learn the technique from lectures and audiovisual materials alone.
A search for a more suitable training method for American doctors turned up few models. Training opportunities for practicing doctors are limited because physicians may practice medicine only in states where they are licensed; furthermore, because of liability concerns, physicians may not touch one another's patients. Clinical training using animal subjects is sometimes substituted for training on human patients, but there is no adequate animal replacement for the human scrotum.
Taking these limitations into account, AVSC initiated a revised one-day orientation program with two parts: a morning didactic session followed by an afternoon clinical session, in which one doctor received hands-on training with several patients while the remaining participants observed by closed-circuit television. In these early programs, as the trainees watched, they manipulated the Chinese instruments, using materials at hand--the tablecloth, their shirt sleeves--to simulate the scrotal skin. Coming to appreciate the value of practice with the instruments, AVSC built a practicum into future orientation programs, so that each doctor could practice with the instruments and a scrotal model under the supervision of a trainer. The model was made of thin red plastic tubing and surgical gauze.
We did not expect that the observation and practicum of the one-day orientation would be sufficient to teach the technique, independent of hands-on training. Therefore, at the same time, we initiated on-site training. In this, doctors learned on their own patients, in their own practices, with individual trainers. Some doctors requested on-site training only, entirely bypassing the orientation program.
AVSC limited access to the Chinese instruments to doctors undertaking on-site training, an unpopular policy that nonetheless produced the desired result: more doctors signed up for training.
We selected trainees by their willingness to undergo training in their own practice, ability to assure a caseload of four to six clients for a one-day instruction session (usually we required 10 cases, but we reduced the number as the trainers' skills increased and advanced scrotal model work was introduced), and willingness to report data on their clinical experience. Priority went to doctors with large vasectomy practices and those in a position to train others or to serve the public sector. Over time, AVSC substantially modified these criteria to include doctors with little or no experience in vasectomy.
Dr. Philip Shihua Li, who had trained with Dr. Li in China, and Dr. T. Rand Pritchett became AVSC's master trainers for the U.S. introduction of no-scalpel vasectomy. Gradually, AVSC identified second-generation American trainers from many regions of the country and helped trainers and trainees to connect, although some doctors independently negotiated scheduling and payments. Trainees obtained training materials (a video, slides, surgical instructions, and scrotal models) and instruments from AVSC, once the training date had been set.
On-site training is characterized by a flexible alternation of discussion, practice on the scrotal model, and the vasectomy procedure itself. Trainers evaluate trainees' skills in performing each step of the technique. Evening or breakfast sessions or grand rounds supplement clinical sessions, as trainees work with trainers to craft programs appropriate and convenient to their settings.
Over the years, AVSC has expanded training to groups of doctors, residency programs, and other organized systems, such as surgery centers and health maintenance organizations. Initially, the trainees were predominantly urologists and family practitioners in equal numbers.
In 1990, Dr. David Stockton and Dr. Larry Davis, assistant professors of family medicine at the University of Tennessee Medical Center in Knoxville, and AVSC sent a joint letter to American family practice residency programs offering training workshops in the no-scalpel technique. Since then, Drs. Stockton and Davis have instructed faculty and residents from family practice programs in various states including Colorado, Illinois, New Mexico, Tennessee, Virginia, and Wisconsin. This third generation of no-scalpel practitioners in turn have trained other family practice physicians. Articles on no-scalpel vasectomy have appeared in "throw-away" and professional journals. No-scalpel trainers have made presentations at the American Academy of Family Physicians (AAFP) section meetings; the 1992 annual meeting of the AAFP in San Diego featured a no-scalpel presentation and workshop.
In the first year, some doctors resisted and argued against hands-on training as a condition for obtaining instruments. They cited far more complex procedures than vasectomy that physicians commonly learn through observation or video alone. One remarked, "It's not brain surgery, you know." To combat these attitudes, AVSC asked clinically trained doctors who had once been skeptical to describe their learning experiences to orientation seminar participants. This helped, but the tension was never entirely dissipated.
Without the "hook" of the instruments, it is unlikely that many doctors would have requested training. For two and one-half years, from 1988 to summer 1990, through an exclusive agreement with Dr. Li Shunqiang and the Chinese instrument manufacturer, AVSC remained the sole U.S. distributor of the specialized instruments.
The two unique instruments needed to perform no-scalpel vasectomy, the dissecting forceps [Figure 1] and the ringed clamp [Figure 2], were key to the success of the program. Their attraction is due largely to the surprising lack of vasectomy-specific instruments in the United States. To perform vasectomy, doctors borrow instruments from other disciplines, such as dentistry or general surgery, perhaps reflecting the offhand view of vasectomy in this country. To produce the original instruments, Dr. Li Shunqiang modified ordinary forceps. The ringed clamp is made to encircle and hold the vas deferens without tearing the scrotal skin; the dissecting forceps is designed to pierce the scrotal skin and to elevate the vas deferens before occlusion.
Doctors who do many vasectomies quickly grasp the instruments' advantages over existing instruments. AVSC's control of instrument distribution was the incentive for doctors to accept hands-on training; we distributed the instruments without charge, but suggested that doctors contribute to the nonprofit program voluntarily, and most of them did.
When commercially produced versions of the instruments began to appear on the market in the United States in 1990, doctors were able to buy instruments and an instructional video directly from several U.S. distributors, without training stipulations, albeit at a substantial cost. The commercial availability of instruments forced AVSC to reassess the orientation seminar policy, and for the first time, we gave doctors instruments without on-site training. The change was also justifiable because of improved trainer skills and training materials, including an illustrated step-by-step surgical manual (Gonzales et al., 1992). Experience has shown that hands-on training is the best way to learn the no-scalpel technique, however, and AVSC continues to refer doctors to trainers for individual instruction.
Physicians trained in performing no-scalpel vasectomy have reported that hands-on training can sharply accelerate the learning curve. We have heard such comments as the following:
The first generation of trained doctors compared patients who had undergone incisional vasectomy with patients who had had no-scalpel procedures. They reported that the latter experienced less operative pain, less postoperative pain, less bleeding, and fewer complications; in addition, the no-scalpel procedure required less time as the surgeon's skills developed. [Table 1]
In 1990, AVSC surveyed 55 doctors about their nonclinical experience with no-scalpel vasectomy. Over half were using the media, the yellow pages, newsletters, and lectures to publicize their practice, and a sizable proportion (38%) reported growth in their practice since introducing the no-scalpel technique. Almost one-third (29%) had trained colleagues to do no-scalpel vasectomy, and about half were planning to train others in the future.
In late 1990, AVSC conducted telephone interviews with 100 men who had had no-scalpel vasectomies (Antarsh et al., 1991). Forty-three percent had been able to find a no-scalpel doctor within five miles of their home. Thirty-two percent had chosen their doctor because he or she did no-scalpel vasectomy; they were drawn by reports of less pain, no cutting, and other benefits. Those who admitted to having had fears before the operation (40%) had been concerned about pain or worried about being cut. Seventy-eight percent recalled feeling little or no pain during the procedure. Fifty-four percent said they had no problems after the surgery. Among those reporting problems, the most common difficulties had been minor swelling or pain. No one had required a second procedure. Respondents' descriptions of the procedure included "simple," "quick," "painless," "a good experience," and "bearable." A small minority reported that the procedure "made me nervous" or "wasn't pleasant."
INFORMING THE MEDIA AND BUILDING DEMAND AMONG CONSUMERS
In China, the new technique is called "ligation of vas deferens with clamp method under direct vision" (Li and Zhu, no date). With the public in mind, AVSC coined the term "no-scalpel" after the technique's most salient characteristic. Although some clinicians object to this "gimmicky" term, the name has taken hold, not only in the United States, but also throughout the world.
The first American no-scalpel vasectomists described their experiences in "throw-away" medical journals. These articles filled a gap until presentations at medical meetings and publications in peer-reviewed journals provided professional credibility. Almost always the "throw-away" journal articles described AVSC's training program, and interested physicians contacted us for details.
Since 1988, AVSC staff have presented papers on the procedure at professional meetings of physicians, public health personnel, and contraceptive health professionals; among these meetings was the first international no-scalpel vasectomy symposium, held in Bangkok in December 1989.
Press kits prepared by AVSC have helped newly trained doctors to inform their communities of the acquired skill. We have informed medical writers, women's magazines, newspapers, and TV and radio stations about the latest developments. Hundreds of articles and programs have resulted from these activities.
As the letters and calls for information mounted, AVSC began compiling a national list of doctors who had received hands-on training in no-scalpel vasectomy. We urge consumers to investigate the skill and experience of any physician whose care they are considering. By December 1992, the list cited 417 doctors in 44 states and the District of Columbia.
DEVELOPING INFORMATION AND EDUCATION MATERIALS FOR DOCTORS AND CONSUMERS
As publicity about the new technique burgeoned, AVSC developed materials supplying information for consumers, including articles, a fact sheet, a brochure, and a video. Doctors themselves needed information. An early attempt to provide a step-by-step description of the technique developed into an illustrated training manual (Gonzales et al., 1992), a training video, and a slide series for doctors. To support the practicum exercises for orientation sessions, experiments with inexpensive materials settled on thin red plastic tubing and surgical gauze to approximate the vas deferens and scrotal skin.
Between February 1988 and December 1992, 417 doctors from 44 states and the District of Columbia received training in no-scalpel vasectomy. They have trained about twice that number in over 20 residency programs and among their colleagues. Studies of clinical and nonclinical aspects of no-scalpel vasectomy are reassuring, production and distribution of training and educational materials are meeting professional and public demand, and AVSC has filled over 3,000 requests for information from consumers. This new approach to vasectomy has attracted more doctors, especially family practitioners, to offer vasectomy, and practicing vasectomists have improved their skills. Whether the no-scalpel technique will become the predominant vasectomy method in the United States is a subject for future assessment.
Working Paper #2 Authors:
Libby Antarsh, regional director, Central Asia, Eastern Europe, and Russia, formerly directed AVSC's programs in the United States. Shelby Marston-Ainley formerly served as assistant director for the United States.
The purpose of AVSC Working Papers is to capture on paper AVSC's experience and to disseminate the results of AVSC-supported research. We welcome your comments and suggestions.
The authors wish to acknowledge Maureen McKenzie and Jeanne Haws for their help with the data. Thanks to Pam Harper for her encouragement to continue and to Dore Hollander for copy editing the manuscript. Renée Santhouse designed the publication.
This publication may be reproduced without permission, provided the material is distributed free of charge and the publisher and authors are acknowledged. This publication was made possible, in part, through support provided by the Office of Population, U.S. Agency for International Development (AID) under the terms of cooperative agreement HRN-A-00-98-00042-00. The opinions expressed herein are those of the authors and do not necessarily reflect the views of AID.
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