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Controversies in Gynecologic Surgery

Introducing New Technologies and Techniques into Gynecologic Surgical Practice

WINKELMAN, WILLIAM D. MD*,†,‡; ROSENBLATT, PETER L. MD*,†,‡

Author Information
Clinical Obstetrics and Gynecology: June 2020 - Volume 63 - Issue 2 - p 266-276
doi: 10.1097/GRF.0000000000000508
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Abstract

Introduction

The surgery practiced today is not the same as the surgery practiced a generation ago and because of the ever-evolving nature of medicine, ongoing education, and adoption of new technology is vital for all surgeons. Despite the fact that various national physician organizations have attempted to develop criteria for the safe introduction of new technology,1–5 there is no formal process for integrating new surgical technologies into hospitals after they are approved by the Food and Drug Administration (FDA). In light of this, it is important that all surgeons feel comfortable assessing, critiquing, and adopting new technology. Surgeons should carefully consider the risks and benefits. Will the technology improve the quality of care? Are there adequate financial and infrastructural resources for implementation? Are there known or potential barriers to adoption? Is adoption compatible with clinical practice?6 Surgeons should also consider when in the technology life cycle they are most comfortable adopting new technology. Some surgeons prefer to stick to traditional devices that have withstood the test of time, while others are pioneers in their field. Each surgeon needs to analyze their own image, the culture of the institution, their willingness to take a risk and the potential risks to patients.

The Technology Life Cycle, Hype Cycle, and Technology Perception Dynamics

The development of medical devices is integral to the advancement of medicine. In general, there are 4 primary categories of innovation; enabling technology, disruptive (or radical) technology, incremental technology, and sustaining technology. Enabling innovations are those that allow for the subsequent development of a derivative technology. For example, the development of general anesthesia and aseptic technique has allowed for the development of a multitude of modern surgical procedures that would otherwise not have been possible. Disruptive innovations are those that replace existing devices. They are very different than devices currently available and often are revolutionary and may lead to entirely new approaches to disease. An example of a radical medical device is the Da Vinci robotic system (Intuitive Surgical, Sunnyvale, CA). The first robotic colpopexy procedures were described in 2006 and minimally invasive abdominal colpopexy procedures have continued to increase since that time.7,8 In fact, in 2009 minimally invasive colpopexy procedures surpassed open abdominal colpopexy procedures as the most common approach.9 The development of Da Vinci has led to an entirely new approach to surgery. In contrast, incremental inventions involve smaller improvements to existing medical devices. For example, the Gynecare TVT (Ethicon, Somerville, NJ) was introduced in Europe in the mid-1990s for the treatment of stress incontinence and subsequently brought to the United States in 1998. Since that time, Gynecare has made several minor modifications to the device, including changing the color of the mesh from clear to blue and making thinner introducer needles, which in theory requires less insertion force. The development of Gynecare TVT Exact (Ethicon), which was launched in 2010, incorporated many of these smaller modifications and overall represents an incremental change from the original version of the Gynecare TVT midurethral sling. Another example of incremental technology is the InterStim II (Medtronic, Minneapolis, MN). The original InterStim has a weight of 42 g, whereas the InterStim II weighs only 22 g and is thinner and smaller than the original. This development has allowed the device to remain competitive in the market. Despite the fact that incremental inventions may involve minor improvements, they can still have a significant impact on the practice of medicine. Sustaining innovations help sustain an existing product by providing enhancements or refining well-established products. Many sustaining innovations are related to the production process and may help bring down the cost of new technology. For example, preimplantation genetic diagnosis has been used in infertility for over 50 years to identify genetic disorders; however, due to sustaining innovations in DNA sequencing the associated cost of preimplantation genetic diagnosis has dropped significantly allowing for more widespread use. For perspective, in 2006, a few years after the Human Genome Project successfully sequenced the first human genome, a full human genome sequence cost around $14 million, but a decade later that price fell to close to $1500.10

The technology life cycle can provide a useful framework for understanding how medical devices evolve over time. New technologies, whether disruptive or incremental in nature, generally follow a predictable life cycle divided into 4 distinct phases (Fig. 1). The first phase is known as the research and development phase, during which there is generally loss of money and negative revenue for the company developing the technology. The second phase is known as the ascent phase, during which the new technology gains popularity after the product is introduced into the market. The third phase is known as the maturity phase when the new technology is widely adopted and approaching market saturation. The final phase is the decay phase when the potential value of the technology declines. Some technologies have an extremely short life cycle such as the intravaginal slingplasty, which was a surgical procedure first described by Peter Petros in 1997, widely adopted, then largely replaced in the mid-2000s by a number of mesh kits, including Perigee and Apogee (American Medical Systems Inc., Minnetonka, MN), Prolift (Ethicon) and Avaulta (Bard, Murry Hill, NJ). Other technologies, such as the Gynecare TVT sling system have had a long life cycle and despite the fact it has been around for over 20 years, is still widely used today.

FIGURE 1
FIGURE 1:
The technology life cycle.

Once new medical technology becomes available, the utilization of the device is thought to follow a “hype cycle,” which is a graphical representation of the life cycle stages of a technology. This concept was developed by Gartner, a global research and advisory firm. The hype cycle represents the maturity, adoption and social application of new technologies. The hype cycle is divided into 5 distinct phases (Fig. 2). The first phase is the “technology trigger.” This may involve a technologic breakthrough and media interest, which in turn may lead to significant publicity. The second phase is the “peak of inflated expectations.” This often comes hand-in-hand with early success stories and as a result, there is widespread adoption. The third phase is known as the “trough of disillusionment.” During this phase, interest wanes and reports of complications and failure may emerge. The fourth phase is the “slope of enlightenment” during which more realistic applications of the new technology emerge. Finally, the fifth phase is the “plateau of productivity.” During this phase, there is broad market applicability and general acceptance of the product for appropriate indications.

FIGURE 2
FIGURE 2:
The technology hype cycle.

The final concept important to understanding the development of new technologies involves technology perception dynamics. This was first described by Rogers in 199511 and portrays the diffusion of innovation. Although technology perception dynamics were initially developed as an economic model and was hypothesized to follow a normal distribution following a bell-curve with a set proportion of the population falling into each category, the exact distribution undoubtedly depends on the specific population. In general, consumers fall into 5 different mindsets in the adoption of new technology (Fig. 3). Innovators are risk-orientated, leading-edge minded individuals who are interested in technological development and are often the first to utilize new technology. Early adopters are a larger but still relatively small demographic segment that follow the innovators. The early majority are a larger group and more risk-averse than the prior 2 groups; however, they are open to new ideas but generally like more outcome information before adopting new technology. The late majority are slightly conservative and risk-averse. This cohort generally needs convincing before adopting new technology. Finally, the laggards are extremely frugal, conservative and technology averse. These are often the last to adopt new technology.12 This concept was similarly described by Gladwell in 2000.13 He felt that technologic changes spread like viruses through “word-of-mouth epidemics.” Gladwell hypothesized that the speed of diffusion of these ideas peaks when adoption approaches 20%.

FIGURE 3
FIGURE 3:
Technology perception dynamics. This figure represents the concept of technology perception dynamics. The dark grey line represents the proportion of respondents falling into each of the 5 different mindsets. The light grey line represents market saturation. As consumers with different mindsets adopt new technology, the technology approaches market saturation.

Understanding these 3 economic principles—the technology life cycle, the hype cycle, and the technology perception dynamics—provides a framework for understanding new technology within medicine.

The FDA Approval Process

The Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act established 3 regulatory classes for medical devices. Class I medical devices are those devices that have a low to moderate risk to the patient and/or user. Today, 47% of medical devices fall under this category and 95% of these are exempt from the regulatory process. Examples of class I medical devices include vaginal retractors, vaginal speculum, uterine clamps, and menstrual pads. Class II medical devices are those devices that have a moderate to high risk to the patient and/or user and around 43% of medical devices fall under this category. Examples of class II medical devices include laparoscopic electrosurgical cutting and coagulation devices, vaginal pessaries, cystoscopies, and surgical instruments used for urogynecologic surgical mesh such as trocars, passers, needle guides, and tissue anchors. Class III medical devices are those devices that have a high risk to the patient and/or user. These devices usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. They represent 10% of medical devices regulated by the FDA.14 Examples of class III medical devices include surgical mesh for transvaginal pelvic organ prolapse repair and implanted electrical stimulators for incontinence.

Medical devices can be approved by the FDA through 4 different pathways. An approved Premarket Approval (PMA) Application—like an approved New Drug Application (NDA) is, in effect, a private license granted to the applicant for marketing a particular medical device.15 PMA is the most stringent type of device marketing application required by the FDA. An application for PMA must contain sufficient valid scientific evidence demonstrating that the specific device is safe and effective for its intended use or uses. This process is costly and time consuming. The FDA only approved 27 medical devices in 2017 and 54 medical devices in 2018 through this process. The majority of medical devices are actually FDA cleared through the 510(k) process. A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective as well as substantially equivalent to a legally marketed device (referred to as a “predicate” device).16 There are 2 other less commonly used means to bring a medical device to market. Evaluation of Automatic Class III Designation (De Novo) provides a means for new devices, without a valid predicate to be classified into class I or class II if they meet certain criteria, thereby bypassing the costly and resource-intense approval process otherwise mandated in the PMA process.17 Humanitarian Device Exemption (HDE) allows class III devices intended to benefit patients with rare diseases or conditions to bypass some of the requirements mandated in the PMA process.18

Within the field of urogynecology, most transvaginal mesh products were approved through the 510(k) process, using the ProteGen Sling (Boston Scientific, Marlborough, MA) as the predicate device, which was first approved in 1996. On the basis of the ProteGen Sling, at least 60 other transvaginal mesh products came to the market including Perigee, Apogee and Elevate (American Medical Systems Inc.), Prolift (Ethicon), Avaulta (Bard), Pinnacle and Uphold (Boston Scientific) as well as a number of synthetic midurethral slings including Monarc and SPARC (American Medical Systems Inc.) and Gynecare TVT and Gynecare TVT-Obturator tape (Ethicon). In fact, the ProteGen Sling, itself, was approved through the 501(k) process and named several predicate devices, including Mersilene Mesh (Ethicon) and Marlex Mesh (Bard).

Following approval by the FDA, some medical devices are subject to 522 postmarket surveillance studies.19 Section 522 gives the FDA the authority to require postmarket surveillance of class II or III devices if any of the 4 criteria are met: device failure would have serious adverse health consequences, it will be used in pediatric populations, it is intended to be implanted for >1 year, or it is intended to be a life-sustaining or life-supporting device used outside a health care facility. Postmarket surveillance in 522 studies are expected to continue for a minimum of 3 years, although these studies may be extended for longer in devices intended for pediatric populations.

Occasionally due to emerging reports of adverse events, devices that were cleared by the FDA without the need for 522 studies are subsequently required to complete 522 studies. It is not uncommon for medical devices to voluntarily withdraw from the market in light of FDA mandated 522 studies, perhaps in part due to the tremendous expenses associated with these studies. Essure (Bayer Corporation, Whippany, NJ), for example, was approved by the FDA in 2002 as a permanent hysteroscopically implanted contraceptive device. In February 2016, the FDA required Bayer Corporation to conduct postmarket 522 studies and mandated a new Black Box Warning describing the adverse events associated with the device. Although 522 studies were ongoing, Bayer Corporation stopped selling and distributing Essure on December 31, 2018 and the 522 studies remain unfinished.

Transvaginal mesh productions have undergone significant changes in regulation in recent years. In January 2013, given emerging concerns about the risks associated with surgical mesh, the FDA ordered 522 studies of mini-sling devices for stress incontinence and surgical mesh used for transvaginal repair of prolapse. At this time, many device manufacturers voluntarily removed their single-incision slings and prolapse kits from the market. In January 2016, the FDA reclassified transvaginal mesh from a class II device (which could be approved by the 510(k) process) to a class III device, which requires a PMA. Following this reclassification, all the manufacturers of transvaginal mesh that remained in the market were required to provide clinical data to support a PMA application. As mentioned earlier, this is a costly endeavor and many companies voluntarily pulled out of the market in light of these new requirements. In contrast, Boston Scientific spent over $30 million on 522 studies looking at outcomes with the Uphold LITE vaginal support system and Xenform Matrix, a fetal bovine xenograft, and even after that enormous financial investment, the FDA mandated withdrawal from the market. The FDA also required the 2 manufacturers who agreed to conduct the 522 studies (Boston Scientific and Coloplast) to complete the studies, despite the fact that they were ordered to remove their devices from hospital shelves and stop manufacturing and selling the devices.

Industry Regulation of New Technologies

Premarket clinical trials of new devices often involve expert surgeons who tend to be familiar with the product, which raises questions about the applicability of study results to general clinical practice. Although the FDA does not generally require end-user training on devices, given concerns about the risks associated with vaginal mesh, in 2008 the FDA recommended that all physicians “obtain specialized training for each mesh placement technique” and reaffirmed this recommendation in 2011.20

Training requirements, however, are becoming increasingly common. A decade ago, the American College of Surgeons found that 8 of 13 FDA approved devices for use in general surgery were approved only with specific training requirements and the proportion of surgical devices requiring training has only increased since that time. The etonogesterol implant Nexplanon (Merck & Co. Inc., Kenilworth, NJ) was approved by the FDA in July 2006 and is one such example. As a condition of approval, the FDA required that Merck & Co. Inc. institute a comprehensive and mandatory clinical training program to ensure provider proficiency with insertion and removal procedures. The Olympus Contained Tissue Extraction (CTE) is another example (Olympus, Waltham, MA). This device was cleared through the De Novo process in 2015 for power morcellation following a laparoscopic procedure for the excision of benign gynecologic tissue that is not suspected to contain malignancy. To use the CTE, however, Olympus requires surgeons complete a formal validated training program.

National Society Guidelines

As mentioned earlier, national societies may occasionally publish guidelines for privileging and credentialing for new medical devices or surgical procedures. These national society guidelines may provide useful guidance but should also be taken within the context of your individual practice settings, patient population, and available resources. The American Urogynecologic Society (AUGS) for example recommends that a sacrocolpopexy should only be performed by surgeons with “board certification or active candidacy for board certification in obstetrics and gynecology or urology who also have requisite knowledge, surgical skills, and experience in reconstructive pelvic surgery.”21 To obtain privileges, AUGS recommends at least 10 proctored procedures and for maintenance of privileges, at least 5 sacrocolpopexy procedures annually. It is important to note that society guidelines often represent the minimum recommended standards and additional training or experience may still be warranted.

THE ROLE OF SURGEON INNOVATION

There is a fine line between innovation and variation of techniques in surgical practice. As surgeons, we modify our techniques and improvise on a daily basis to meet the specific clinical scenarios and unique anatomic findings of our patients. Throughout our surgical training, we are encouraged to troubleshoot intraoperatively and think creatively to adapt to the present operative situation. In contrast, there are times when a surgeon might consider a novel approach to surgery, to make the procedure safer, more effective, more efficient, or even to address an unmet clinical need. Although there is no accepted definition of “innovation,” many surgeons believe it is characterized by a significant change in currently accepted practice, and where the outcomes are not fully known. It is incumbent upon surgeons to approach innovation in a logical, ethical and responsible manner. This includes careful planning, which may include the use of pelvic models or other types of low-fidelity simulation. Although surgeons may use devices “off-label” for practical or innovative applications, they are certainly responsible for their decisions from a medical-legal perspective. For general guidance on using devices off-label, we would encourage surgeons to check with the hospital surgical committee or the hospital ethics review board. If considering data collection or a research protocol either using devices off-label or implementing a new surgical innovation, seeking input from the institutional review board may be helpful.

One personal example of bringing an innovative procedure to clinical practice was the development of the Trans-Obturator Post-Anal Sling (TOPAS) system for the treatment of fecal incontinence which was first described by Rosenblatt et al in 2014.22 The idea was to support the normally present anorectal angle, which is the result of the “sling-like” effect of the puborectalis muscle on the anorectum. With the procedure, a lightweight synthetic mesh sling is placed under the anorectum and the arms are supported in a self-affixing manner through the obturator membrane; similar to a transobturator urinary sling. The author (P.L.R.) developed his technique using cadavers and then received approval from his hospital surgical committee to perform the procedure on properly consented patients. The procedure proved to be safe and effective on 15 patients and was ultimately developed and manufactured by a company that produced transvaginal mesh devices. This company performed a pilot study on 29 women in 5 centers, confirming the reproducibility of the results, and subsequently a pivotal Investigational Device Exemption (IDE) study was performed in 14 centers throughout the United States, which was a nonrandomized prospective study of 152 women with fecal incontinence assessing safety and efficacy.23 An FDA panel was convened in 2016 to evaluate the device in terms of safety, efficacy, and risks versus benefits. The 8-member FDA panel unanimously voted to recommend approval of the TOPAS system based on these 3 parameters. Unfortunately, the following week, the parent company announced that it was shutting down operations of its medical device company due to transvaginal mesh litigation and settlements in the billions of dollars. Although the author was able to get back the intellectual property (IP) associated with the TOPAS system, this device, which was proven to be safe, effective and was unanimously approved by the FDA panel, is not currently available for patients as a result of transvaginal mesh-related litigation.

When a surgeon develops an innovative technique or device, there are several things that should be considered. First, the physician should check his or her contract with the hospital, employer, university or other institution with whom they are affiliated, to check on the rules governing IP. Although some contracts do not restrict physicians from pursuing their IP by themselves, more commonly there are policies and procedures that govern these ideas. It is important to review these policies and procedures before too much work is put into the development of the innovation. It may also be important to file for a patent to protect one’s IP. The inventor may consider speaking with an attorney that specializes in patents to evaluate the idea and provide an opinion as to whether the idea or device is patentable. The US Patent office has an inexpensive method of protecting IP with the filing of a Provisional Patent. This is a simple way to protect one’s IP for up to 1 year, and before the year is complete, the inventor must file a nonprovisional patent application to preserve the “priority date” associated with the provisional patent. During the year that the provisional patent is active, the inventor may state that the idea is “patent pending,” which offers significant protection under patent rights. Before speaking with anyone else about the invention, including colleagues who may provide their opinions and advice or companies that might be interested in licensing the product, we recommend signing a confidential nondisclosure agreement, which further protects the IP surrounding the concept.

Implementation of New Technology in Your Practice

In surgery, innovation generally comes either as a new procedure using existing devices or an existing procedure that uses new devices. Surgeons generally look favorably on new technology if it can be passively observed, easily learned, and assimilated in their existing practice with minimal disruption. If the potential contribution to their practice is sufficiently great, surgeons are more likely to invest time and effort and tolerate disruption of their routine to gain the competitive advantage that new technology offers.

There are many ways for surgeons to learn about medical devices ranging from a literature review of outcomes, online courses, meeting courses, video reviews, expert input, simulator practice, animate model training, cadaver course training, proctorship or tele-proctorship, and team training. Each of these offers strengths and weaknesses and for many medical devices, the ideal training may be a combination of multiple elements.

Perhaps a reasonable first step in the implementation of new technology is for a surgeon to familiarize themselves with the medical literature. It’s important to know the published outcomes and efficacy. For devices approved through the 510(k) process, it may be important to become familiar with the predicate devices. What were the shortcomings? What obstacle is the new device trying to overcome? If the literature review seems favorable, then the surgeon may decide that it is reasonable to seek additional training. Many device manufacturers offer training courses, and surgeons should talk to local device representatives who can often help arrange additional training. National and international conferences are also often sponsored by device manufacturers and there may be opportunities to learn about new devices or attend industry-sponsored events where surgeons can get hands-on experience with various devices. For some devices, a hands-on training course may be more appropriate, either with animate models or cadaveric training courses. Perhaps the most useful method, although more costly and time-intensive, involves proctorship, and hands-on training with another surgeon. Institutional proctorships and preceptorships can provide valuable learning opportunities under a more experienced surgeon in a more structured manner.

It has been our personal experience when introducing innovative devices or techniques to clinical practice, that the surgeon should take “baby steps” when possible to avoid frustration and gain familiarity with the instrumentation. For example, when converting from 5 to 3 mm laparoscopic port sites, the surgeon may want to start with changing only one of the port sites to a 3 mm size and keeping the other port sites at a familiar size. With experience, the surgeon may then choose to convert additional numbers of port sites to the smaller size in subsequent cases.

When adopting new technologies, it is essential for the surgeon to monitor his or her own experience, to determine whether the technology provides equivalent or improved outcomes and whether there is any change in intraoperative or postoperative complications. Auditing one’s experience is an important component of adopting innovation, whereby the risks and benefits are evaluated objectively, keeping in mind that there may be some degree of a “learning curve” associated with innovative procedures. Obviously, however, the learning curve should not put patients at risk for serious adverse events.

It is essential for surgeons to obtain informed consent from patients before a procedure is performed, regardless of whether it is a traditional or innovative procedure. The term “optimism bias” refers to the tendency of surgeons to have a partiality to a new technique that they have been trained on or are excited about performing. This enthusiasm may influence how the surgeon speaks to the patient about the new procedure, whether consciously or unconsciously, and every effort to avoid this type of bias should be taken. Although early adopters of new technologies usually have some idea of the risks and benefits associated with the procedure through literature, including pilot or pivotal studies, some innovators may not have the benefit of being able to rely on other surgeons’ experience to guide their decision to implement novel techniques or devices. Both the short-term and long-term risks of the procedure may not be fully known to the surgeon. It is incumbent upon the surgeon to acknowledge this uncertainty, and to make an educated guess, and to let the patient know that it is an educated assessment. Similarly, it may be equally difficult to quantify the potential benefits to the patient. Being honest with the patient and allowing her to participate in the decision-making process is the guiding principle, and may very well result in the patient deciding to undergo a traditional operation rather than the novel procedure.

Conclusions

New technology has the potential to revolutionize the way we practice medicine; however, it is important to understand the context in which new medical devices arise and to approach new medical devices with a healthy combination of skepticism and optimism. The implementation of new medical devices can prematurely waste resources, and/or cause inadvertent harm to patients. In contrast, delaying the implementation of technology could stifle the progress of medicine and prevent patients from benefiting from innovative and improved treatments.

References

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Keywords:

technology; innovation; FDA

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