Deputy Editor of Contemporary OB/GYN, Director of the Division of Minimally Invasive Gynecologic Surgery at Brigham and Women’s Hospital in Boston and professor of Obstetrics, Gynecology and Reproductive Biology at Harvard Medical School.
Innovation is a major component of gynecologic surgery and surgeons at all levels play a role in progressing the specialty
As gynecologic surgery continues to evolve rapidly, it is easy to forget the origins of our specialty. Only 205 years ago, Conrad Langenbeck performed the first planned hysterectomy on record. It was a vaginal procedure done in the surgeon‘s living room with no assistants and he had to use his teeth at one point to tie suture. Miraculously the patient survived, but no one believed that Dr. Langenbeck actually performed this procedure until it was confirmed at autopsy several years later.
In today‘s environment, the laparotomy approach is still overutilized, but it is now gradually being replaced by laparoscopic and robotic surgery. The original minimally invasive method, the vaginal hysterectomy, is slowly on the decline despite efforts by the American College of Obstetricians and Gynecologists to turn the tide. There is no question that vaginal hysterectomy is a great minimally invasive approach, but with fewer surgeons capable of teaching this skill and a paucity of technological innovation in this space, vaginal hysterectomy has been left wanting compared with the laparoscopic approach. In this regard, other developments on the horizon, which I will discuss later, have the ability to further cement the laparoscopic minimally invasive visual approach as the primary mode of access for gynecologic surgery.
The impact of MIGS training and subspecialists
As compared with vaginal hysterectomy, one important factor tilting the scales is development of minimally invasive gynecologic surgery (MIGS) fellowship programs. Over 300 MIGS-trained subspecialists have graduated from fellowship since 2001, and every year 30 to 40 new MIGS-trained subspecialists pollinate the US landscape and start to operate on patients. Introduction of high-volume MIGS subspecialists is changing the landscape of gynecologic surgery, moving a large portion of the surgical volume away from generalist specialists to MIGS specialists. A similar evolution happened in gynecologic oncology a couple of decades ago with the advent of gynecologic oncology fellowships. Whether this is the ideal solution for the discipline as a whole can be argued, but it is likely that within the next 10 to 20 years, most complex benign gynecologic surgeries will be performed by subspecialists and several recent studies have demonstrated in multiple arenas that high-volume surgeons have better outcomes and fewer complications.
The robotic surgery landscape
Another exciting development is a new revolution in robotic surgery that we are about to witness. Until recently, Intuitive Surgical was the only game in town, but recently the Senhance surgical robotic system was launched in the United States. Other robotic systems are on the horizon, some from major players in the market such as Medtronic and J&J in collaboration with Google, but also a variety of systems from other companies. It seems evident that with increasing competition, innovation will be rapid and prices will come down. This will benefit patients and surgeons and reduce the overall cost of the healthcare system. While I have personally been critical of robotic surgery as a poor value proposition in its current iteration, I now see the possibility that in time, robotic surgery will be offered at a signficantly lower cost and offer true value such as automation and greater safety for patients.
Augmented visualization is also going to be something we will see increasingly in the near future.
Fluorescence-guided surgery is already in clinical use, but several companies are developing tools that incorporate augmented reality in which three-dimensional images from computed tomography or magnetic resonance imaging can be overlaid onto the surgeon‘s console or monitored in real time. This can help the surgeon better determine exactly where to make an incision and see healthy tissue margins. There are also several dyes and imaging enhancements being developed for display of various tissue types on the monitor in distinct colors. In time, a surgeon will be able to see the anatomy almost as if it were in an anatomy atlas, with nerves, ureter, bowel, and muscles all in different colors on the monitor. Essentially, it will be a kind of a surgical GPS that guides the surgeon to address the correct pathology while avoiding injury to vulnerable nearby structures.
Continued innovation is the driver of this progress. Large multinational medical device companies lead the way in development of novel medical devices and equipment, but the importance of small startups should not be underestimated. Small startups are generally run by passionate and knowledgable founders who have identified a significant unmet need and are able to move quickly through development of their devices because of their small organizational structure and the unified drive of the group. The main challenge for small startups is access to funding and it is well recognized that most of these companies will ultimately fail, often because they run out of money. However, there are inspiring success stories. One is Surbhi Sarna (now 32 years old) who was diagnosed at age 13 with ovarian cysts. Her doctors did not know if the cysts were cancerous, which inspired Ms. Sarna to found a company, nVision Medical. The company raised $17 million in venture capital and received approval from the US Food and Drug Adminstration (FDA) to develop a specialized device to detect ovarian cancer before being aquired by Boston Scientific for $275 million. It is obvious that Ms. Sarna is a very gifted individual to have accomplished this at such a young age, but it is nevertheless a good example of the power of the individual entrepreunial spirit.
Navigating the regulatory system
The regulatory environment for medical devices has recently come under increased scrutiny, such as is shown in “The Bleeding Edge.” In this documentary, the medical device industry is painted in a rather negative light, with the focus on (among other things) issues that are directly pertinent to women’s health, such as Essure sterilization implants, vaginal mesh, and robotic surgery. The documentary highlights some potential problems with the current regulatory system for medical devices. The 510(k) pathway enables medical device companies to bring a device to market based on a similar device that is already on the market, called a predicate device. The problem is that sometimes the approval of that predicate device is based on a string/hierarchy of other predicate devices, meaning that the original predicate device is no longer on the market and in some cases may be outdated.
On the other hand, the 510(k) pathway enables small startups to bring their innovations to market without going through the premarket approval (PMA) process, which includes a clinical trial, a usually cost prohibitive step. In addition, even if a clinical trial is done, it may not necessarily prevent injury or issues for patients later on. An example of this is the Essure sterilization system. The device did go through the PMA process with a rigorous clinical trial, but because of the relatively short follow-up period, the problems associated with Essure were not discovered until several years after the clinical trial was completed.
The FDA’s current system for medical device approval is designed to balance the need to protect patients while continuing to encourage innovation. One obvious downfall is that the FDA’s MAUDE (Manufacturer and User Facility Device Experience) database relies on voluntary reporting from doctors, nurses, and patients while reporting is mandatory for manufacturers, importers, and device-user facilities. Consequently, there is a potential for underreporting and there is a risk for late detection of problems with medical devices, ie the issue is not detected by the FDA or authorities until there has been significant patient harm. There seems to be a need for a more comprehensive nationwide database to protect patients, wherein medical device complications are registered prospectively and registration is mandatory by all parties.
In summary, innovation in surgery is necessary if we wish to see improvements in patient safety and overall care. However, ideas alone are not the sole component. Innovation requires skilled surgeons willing to teach, less-skilled surgeons willing to learn, and a regulatory environment that properly protects patients without barriers that are too high to allow technology to evolve. ï¼