August 2010

Seduction By Robot

Seduction by robot??? Sounds strange does it not? But that is exactly what appears to be happening at a hospital near you. Perhaps you have not yet heard of the da Vinci Surgical System. However, I can assure you, your hospital administrators have, as have the surgeons who practice in your area. What is it? When did it arrive on the scene? And, perhaps, most importantly, why should you care?

Originally launched in January of 1999 by Intuitive Surgical, The da Vinci Surgical System is described by its creators as "a sophisticated robotic platform designed to enable complex surgery using a minimally invasive approach. The da Vinci System consists of an ergonomic surgeon's console, a patient-side cart with four interactive robotic arms, a high-performance 3D HD vision system and proprietary Endowrist instruments. Powered by state-of-the-art robotic technology, the da Vinci System is designed to scale, filter, and seamlessly translate the surgeon's hand movements into more precise movements of the Endowrist instruments. The net result is an intuitive interface with breakthrough surgical capabilities."

Wow! Sounds great, does it not? Sign me up! As a surgeon, I cannot wait to place my hands on one of these things. What patient would not want their surgery to have this technology incorporated into their procedure? "Seamlessly translate the surgeon's hand movements into more precise movements, state-of-the-art, breakthrough surgical capabilities." Seems like a no-brainer, right? Hospitals around the nation and the world seem to think so. And they have snatched these robots up in a "We don't want to be left out" frenzy. Many surgeons have also been eager to jump on board. However, wait a tick. Let us take a closer look.

There exist several potential issues with this device as well as issues with how it has been marketed. Some of these include the cost of the device, monthly maintenance costs, significantly increased operative times, steep learning curve, increased complications and, at least in one area, presentation of the robot as the least invasive approach when a lesser invasive procedure is available. These potential problems deserve a closer look.

Consistently, the cost of the da Vinci Surgical System is reported to be $1-1.2 million. A hospital administrator recently informed me that the monthly maintenance for the system is in the neighborhood of $10,000.00. That is a significant amount of money. Add to that the enormous cost of training in terms of both time and money, and we are talking about an even larger sum. This is something of which any hospital system that acquires one of these robots will be acutely aware. This presents one of the issues I have found most concerning surrounding this device, more specifically, its marketing.

Several times over the last year I have received and read advertisements with invitations for people in neighboring communities to attend a meeting or dinner to learn about a new minimally invasive procedure available for hysterectomy. This, in and of it itself, poses no problem. However, the slant presented appeared to be that this new technology (read robot) was less invasive than "traditional" hysterectomy. This is where the problems arise.

There can be no argument that the LEAST invasive hysterectomy is a vaginal hysterectomy. The vaginal hysterectomy has also consistently proven to be the safest in terms of dangerous complications like ureteral injury. However, the purpose of these meetings is to "inform" people of this less (read, least) invasive option of robotic hysterectomy. A more skeptical assessment might be that these meetings intend on "selling" prospective hysterectomy patients on the idea that this robot offers the least invasive approach to hysterectomy.

Let us not forget, these da Vinci systems are extremely expensive and it appears from these marketing efforts, that these hospital systems are looking to drum-up business to help cover their costs. If, in so doing, they are deliberately misleading patients that the robot offers the LEAST invasive option for hysterectomy, then it is at a minimum wrong, and at worse, potentially assault and battery.

But let us back-up for a moment. Let us examine potential issues with this da Vinci Surgical System craze in more general terms. When news began making its rounds in surgical circles about this device and as most of us watched procedures being performed "robot-assisted", there was one comment heard time and time again. That comment was that the system seemed to be a "technology looking for an application." In other words, yes, this is an interesting, fancy machine, but it really had not been able to demonstrate a benefit in any particular area of surgery that could come close to justifying its enormous costs. Keep in mind that these costs consist of much more than the cost of the machine itself and its monthly maintenance costs (which we have seen are substantial), but the enormous costs in terms of increased surgical times, increased anesthesia costs and increased costs of surgical training.

These are some of the costs speaking in financial terms. Potential personal costs to the patient include increased operative times, increased time under anesthesia and the potential for increased operative risks and injury. More on this in a moment.

When I first began learning about robotic assisted surgery, the one area where they felt they could definitively state that there existed a significant proven benefit to the patient when robotic-assisted surgery was employed was in the area of a radical prostatectomy. There existed decreased risk of erectile dysfunction and other morbidity and the surgeons apparently really raved about the benefits of robot-assistance with this procedure. Radical prostatectomy is way out of my area of expertise but it certainly sounded reasonable to me at the time and I was pleased to hear they had a truly beneficial application for the technology. However, recently when speaking to a urology colleague about the incidence of complications in robot-assisted surgery he informed me that his colleagues were beginning to question this benefit and some of their contemporary literature was refuting it, as well.

It was during this conversation that I was discussing another of the potential issues with this robot-assisted surgery, that is of complications and what is more concerning, unrecognized complications. Any surgeon will tell you that if you operate enough, eventually, you will have complications. There is no way around it. It is part of surgical medicine. The best, most gifted surgeons in the world have surgical complications. One strives, as a surgeon, to minimize complications through thorough training, proper preparation, careful surgical technique and vigilance. Even with all of these things sometimes complications will occur. When they do occur, you, as a surgeon, want to recognize that a complication has occurred and address it appropriately and timely thus minimizing the impact it has on the patient.

We have already mentioned that the learning curve for physician training with the da Vinci system is very steep and time-consuming. It is one of the few, if not only, products on the market of which I can think that charges the surgeon a fee to learn how to use its product. The system itself is very hands-on and labor intensive not only for the surgeon but for the operating room personnel, as well. It only makes sense, that depending on where any given surgeon is on that curve, the potential for complications may increase. The discussion I was having with this urologic colleague stemmed from a patient recently referred to me following a robot-assisted gynecologic procedure during which the patient sustained injuries to her bladder and ureter. The ureteral injury was unrecognized at the time of surgery. This colleague discussed with me the increasing number of robot-assisted surgical injuries that he is seeing in his practice, as well.

There are numerous surgical fields that are attempting to incorporate robot-assisted procedures into their practice. I have read some reports from cardiovascular physicians and oncologists who report enjoying using the da Vinci Surgical System and feel it has benefits in their field. You can read many of these posted on the company's website (perhaps, not the most objective source). As I have no expertise in those fields I am not qualified to opine. Where I can voice concern is in my own area of expertise in how this technology is being employed in gynecology. I recently had a conversation with a gynecologic oncologist who was planning to use the robot in a benign gynecologic case, not because the robot offered any particular benefit to the patient, but simply because he wished to use the robot. Never mind the aforementioned increased cost to the patient and our medical system but also the increased operative and anesthesia times and potential risks. This is concerning.

When discussing increased operative times, we are not talking about 20-30 minutes. Unfortunately, doubling, tripling and even quadrupling of operative times is common. Approximately 3 years ago when returning from a medical conference I was discussing the pros and cons with one of the more experienced "robotic" surgeons in my area. He stated that, at the time, a case that might require 45 minutes for him to complete with traditional laparoscopy might require 2.5 to 3 hours with the robot. He reported that he did not mind the increased operative time because he really enjoyed robotic surgery. And this, he reported, was a significant improvement over the initial increase in operative times. He explained that one could expect even longer times when first learning the system. Is this reasonable? Is this acceptable in the field of gynecology, or in any field for that matter? Does the end justify the means? When is this the best approach? Most cost-effective? Safest? Is it ever any of those things or does it offer all those things and more? The answers to these questions are certainly not clear and require further evaluation, at a minimum.

There are often numerous choices in the approach a surgeon uses to perform a procedure. Some surgeons are trained in multiple approaches to the same procedure, others perhaps only one. Numerous factors go in to deciding on which procedure is most appropriate. Factors include surgeon's skill, patient factors such as their health, size, or organ size, as in hysterectomies. Never should a more invasive procedure be chosen simply because a physician finds it to be more "fun" or "interesting." Additionally, a procedure should never be chosen because it is a part of an efficient marketing machine. I was caught a little off-guard the first time I saw a physician advertising themselves as a "robotic surgeon." Does that sound like a good thing? I know what they are trying to say/advertise. But does anyone truly want a "robotic" surgeon? Not me. I want a skilled surgeon who has the ability, adaptability and fluidity to adjust their approach as the case requires, not plod aimlessly forward in robotic fashion without regard to the circumstances of the specific case. This is clearly not what they mean, but it sounds a little odd.

The most appropriate procedure should always be the least-invasive procedure that can be safely performed in a particular surgeon's hands at a given surgical facility.

I am not saying that there does not or never will exist a place in medicine for robot-assisted surgery. I personally know many well-respected surgeons who are using the product and believe it offers a benefit in their hands. I am simply saying that in a world with an increasingly scarce healthcare dollar we should tap the brakes a bit and determine if this or any other technology is appropriate for any given medical field. And whether it truly offers a cost-effective benefit to our patients without increasing their risks.

Contraception: You Have Come a Long Way Baby!

Since the early 1900's, when Ludwig Haberlandt, an Austrian physiologist working out of the University of Innsbruck, was feeding ovarian extracts to mice, we have known that the administration of certain hormones leads to inhibition of fertility thus providing contraception. However, it was not until the 1960's, coincidentally coinciding with the sexual revolution, that 'The Pill' made its rather conspicuous debut.

Decades later this relationship continues to flourish as a third generation of women begin to reap the benefits of reliable contraception. Hormonal contraceptives provide numerous well-documented non-contraceptive benefits also. In fact, in March of this year a study of 46,000 women conducted over a 40 year period found that women on 'the pill' are less likely to die prematurely of any cause including cancer and heart disease. Indeed, approximately 100 million women world wide are taking some form of oral contraception.

But this is the United States of America. We love our freedom. We love choice. And we REALLY love freedom of choice. As such, women today have a plethora of options when choosing a contraceptive. With the pill alone you have mono-phasic, multi-phasic, 21 day, 24 day, continuous, progesterone-only, as well as numerous estrogen and progesterone combination options just to name a few. These are just 'pill' options.

What makes the choice landscape that much more rich and interesting are the non-pill options. These options are as unique and varied as the individual women they are designed to serve. They include patches, rings, implants and intra-uterine devices. Each of these options have specific advantages and disadvantages to fit the lifestyle and medical needs of different patients.

First, let us consider the patch, Ortho Evra. These patches are structured and work in much the same way as oral contraceptives in that women receive a combination of estrogen and progesterone for the first three weeks of the month with the fourth week hormone free during which time she will experience menses. However, with this method, she will not need to remember to take a pill everyday. Rather, she simply needs to change the patch once a week during the first three weeks and is patch free in the fourth week. Another advantage espoused by this method is that it avoids what is known in the medical field as the 'first-pass effect' where by a medication is first processed by the liver.

You like the idea of not having to take a pill daily but are not so sure about wearing a patch on your skin? No problem! The Nuva Ring may be the answer for you. The Nuva Ring is a vaginal ring that is placed vaginally and the hormones are absorbed through the vagina, also avoiding that 'first-pass effect' through the liver. Additionally, because the vagina is very vascular, it readily absorbs hormones easily, allowing the makers of Nuva Ring to use a lower dose with less fluctuation in hormone levels that one might have when taking an oral contraceptive. Lower dose with less fluctuation of hormone levels can equal fewer side effects.

To use the ring, you simply place it vaginally, leave in for three weeks, then remove and menses will occur in the fourth week. Then repeat the cycle. Additionally, if you would like to skip a menstrual cycle, say for vacation or convenience, each ring has enough hormone to last for four weeks. Therefore, simply leave the ring in for a full four weeks, remove, and immediately replace the ring with a new one.

The Nuva Ring is left in during intercourse. Nine out of 10 men reported not feeling the ring at all and the 10% who did, stated that it did not bother them.

If you like the idea of less frequent dosing of hormones and these less labor intensive options but would like to take it even further, perhaps an implant is the answer for you. Implanon is a distant cousin of the once popular implant, Norplant.

Implanon has the convenience of, once being placed by your physician, providing effective contraception for 3 years. Implanon is placed via a simple in-office procedure where by the device is placed just under the skin of the non-dominant arm in the space between the biceps and triceps muscles on the inner-arm. Implanon is a progesterone-only option and although some women will have some irregular bleeding, many have no period, at all, which they find convenient.

Finally, for those women who would like an even longer term and either completely non-hormonal or less-hormonal option, there are intra-uterine devices. These have the benefit of, once being placed, providing reliable, effective contraception for 5-10 years with minimal or no hormone.

Mirena is a progesterone IUD that once placed provides 5 years of contraception with minimal use of hormones. The progesterone that is present in the IUD helps some women decrease the amount of menstrual flow they experience with their periods.

Paraguard is a completely hormone-free copper IUD that, once placed, provides 10 years of hassle-free, cost-effective contraception. Should a couple decide they are ready to conceive again, both IUDs can be removed easily by their physician and the couple can proceed with trying to conceive.

All of the above options have their risks and benefits which must be discussed with your physician. But the women of 2010 have more choices now than ever before and enough freedom to choose to make anyone from the 1960's envious of the contraceptive environment of today!

The Flu, Vaccines, Pregnancy and You

It seems we have always talked of 'the flu' and 'the flu shot', but over the last several years we have been inundated with stories of new forms of the influenza virus that sound as if they would have greater importance to veterinarians than to medical physicians. First we were warned of avian or bird flu and more recently, of course, swine flu or H1N1. Not surprisingly, both of these viral forms have many looking at our avian and mammalian friends with a more suspicious eye. But these critters are actually reservoirs for these viruses. What is influenza? How is it spread? How is infection treated and who should be vaccinated? And what if I am pregnant? All of these are important questions.

The influenza virus causes an acute upper respiratory illness accompanied by fever. This highly contagious infection is spread by respiratory droplets and usually occurs as an epidemic, or in the case of the 'swine' flu, a pandemic, during the winter months. 'The flu' or an influenza viral infection is characterized by the abrupt onset of fever, chills, headache, achy, sore muscles and general malaise accompanied by respiratory symptoms such as a dry cough and runny nose. Complications of influenza infection include pneumonia, which occurs in up to 12 percent of influenza-infected pregnant women.

Treatment of influenza infection includes supportive care with rest and hydration and, in non-pregnant women, anti-viral medications. Because the effect of antiviral therapy on the fetus is not known, its use in pregnancy is limited to cases of severe infection where the benefits outweigh the risks.

Who should receive the seasonal influenza vaccine? According to the Centers for Disease Control it is recommended that the following individuals receive the seasonal influenza vaccine:

1) Children aged 6 months to age 19 years
2) Pregnant women
3) Persons aged 50 years and older
4) People of any age with certain chronic medical conditions
5) People who live in nursing homes or other long-term care facilities
6) Those persons who live with or care for individuals at high risk for complications of flu including healthcare workers and household contacts of those at high risk for complications from the flu and household contacts of those less than 6 months of age.

A question I receive almost daily is whether or not one should receive the influenza vaccine if they are pregnant. Not only may pregnant individuals receive the flu vaccine when they are pregnant, but it is recommended. Both the American College of Obstetrics and Gynecology and The Centers for Disease Control recommend vaccination of all pregnant women during the influenza season. Vaccination can be performed at any time and at any gestational age using the intramuscular, inactivated vaccine and this vaccine is safe in breastfeeding women. The intranasal vaccine uses live virus and should not be used in pregnancy.

In terms of the H1N1 vaccine (swine-flu vaccine) due to be released in October, similar recommendations for who should receive the vaccine have been expressed by the CDC and the healthcare community including the vaccination of pregnant women. Much apprehension surrounds this recommendation because many feel this vaccine has been rushed to market and, because it is a new vaccine, there exists a fear that little is known about its safety profile.

In at-risk individuals, the benefits are thought to greatly outweigh the risks. In pregnant individuals specifically the likelihood of hospitalization from severe symptoms is four times greater than in the general population and six percent of confirmed deaths from H1N1 infection have occurred in pregnant women. It is important to remember that pregnant individuals are in an immunocompromised state and they, therefore, have greater difficulty fighting these infections.

As for concerns regarding the preparation of this new H1N1 vaccine, each year a new seasonal influenza vaccine is formulated with the intention of protecting people against the three strains that are predicted to be the greatest threat. Although the H1N1 virus poses unique health risks, the process through which the vaccine has been developed is largely the same as for the seasonal influenza vaccine.

There are currently studies on H1N1 vaccination in pregnancy ongoing at Baylor and the University of St. Louis. We hope to gain more detailed information about this vaccine in pregnancy through these studies. In the meantime, it is recommended that at-risk individuals, including those who are pregnant, receive the vaccine.

I hope you have found this brief summary to be both useful and informative and remember, if you have questions or concerns, there is no substitute for direct consultation with your healthcare provider.

Incision-free Tubal Ligation

Be Sure About Essure and All of Your Permanent Contraceptive Options

One of the most important and often difficult decisions a woman must make is whether or not permanent contraception or sterilization is the right choice for her. Frankly, I have never cared for the word 'sterilization. It has always sounded so cold and austere, so permanent. It is, of course, permanent and that really is the point. In order for a woman or couple to consider permanent contraception they really must be 100% sure they have completed their family and that their desire for future fertility is gone for good.

In one study, anywhere from 2 to 2.7% of women in the United States expressed regret following tubal ligation at 1 and 2 years post-operatively and approximately 2 per 1000 will undergo tubal reanastomosis. The main factors associated with regret 2 years after tubal sterilization were age less than 30 and sterilization performed at the time of cesarean section. It is also important to note that rates of success following reanastomosis vary greatly depending upon the method used for sterilization. It is, therefore, extremely important that a couple undergo counseling about the permanence of the procedure. Proper counseling should include a complete discussion which includes information about all available methods of contraception both permanent and temporary.

Once a patient decides that permanent contraception is right for her she must then decide on the method she finds most desirable. Options include vasectomy for the male partner and tubal ligation or interruption for the female partner. There exists a seemingly never-ending list of procedures available all of which are provided through one of three approaches: open, laparoscopic and, now, incision-free. Open procedures include tubal interruption performed at the time of cesarean section as well as post-partum tubal ligations performed following vaginal delivery. These procedures require an umbilical incision through which the tubes are accessed and include methods with sometimes 'catchy' names like the Pomeroy or the Uchida.

Numerous procedures are available through the laparoscopic approach, as well. The laparoscopic approach generally requires 1 to 3 small incisions in the abdomen depending upon the surgeon's skill and technique as well as the procedure chosen. The methods utilized with this approach include various forms of cautery or 'burning' as well as a variety of methods utilizing clips, bands or rings. Some of these methods sport equally 'catchy' names like the Hulka clip or the Filshie clip.

Of all of the current methods of tubal interruption, however, the one which most would consider most desirable would utilize an incision-free approach, for obvious reasons. The Essure method provides just such an approach.

The Essure tubal sterilization technique is an incision-free method of sterilization that utilizes a hysteroscopic approach. Hysteroscopy is a surgical technique which utilizes a camera placed through the cervix thus providing visualization of and surgical access to the uterine cavity without the need for a surgical incision. Specifically, with the Essure technique, the hysteroscope is used to access the tubal ostia where the fallopian tubes enter the uterine cavity. Then, under direct visualization, an extremely small, soft and flexible micro-insert is placed at each tubal ostia thus causing a tissue in-growth reaction resulting in tubal occlusion and thus, sterilization.

The Essure technique provides many advantages over other more traditional techniques. Essure can be performed in-office with minimal anesthesia and has virtually no down-time. Because it is incision-free there is usually no discomfort and patients can easily return to work or to caring for their families the following day. And because the Essure procedure can be performed in-office, a hospital stay or visit is unnecessary, saving the patient both time and money as well as being a more cost-effective option for our healthcare system as a whole.

If you are considering permanent contraception please consult with your healthcare provider to learn if Essure is right for you.

back to top