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July 22, 2017  
UTERUS1 HERO

Dr. Mark Glasser: Inventing New Technologies

Dr. Mark Glasser: Inventing New Technologies for Patient Care


September 28, 2004

Doctor Mark Glasser is a California physician who specializes in minimally invasive procedures in the area of obstetrics and gynecology for Kaiser Permanente. He is an active member of the American Association of Gynecologic Laparoscopists, having served as a Trustee and currently a member of the Editorial Board of the Journal of the AAGL. In addition to his work as practicing physician, he has also worked closely with medical technology companies to develop several instruments that are now used in the field of minimally invasive surgery. Dr. Glasser spoke with Body1.com about the excitement of participating in his field as both a doctor and an inventor, the challenges and thrills of being involved in a rapidly changing area of medicine, and some of the difficulty faced by proponents of minimally invasive procedures.

Uterus1: When did you know you wanted to become a doctor?


Dr. Glasser: Oh, long, long ago. Probably when I was a teenager. I thought it was a great thing to do, a great field to be in, and it would give me a chance to utilize my eye-hand skills—I was always a great tinkerer, an inventor of things—I knew I liked to talk to and interact with people and make them feel good.


Uterus1: And how about the decision to specialize? How far along were you in medical school when you decided on that?


Dr. Glasser: I think I decided on that during my second year of med school while on the OB/GYN rotation. This specialty really offered a great combination of medicine and surgery with the added benefit of obstetrics being a happy specialty. That had a lot of appeal for a young medical student at the time. Also, I really liked the people involved.


Uterus1: You think of yourself as a tinkerer and a builder. Does the heavily technological component of current obstetrics and gynecology—things like laparoscopic surgery and other procedures that have come into the field in the past decade or so—appeal to that creative part of you?


Dr. Glasser: Well, it certainly has, since my area of interest is minimally invasive surgery. I’ve been involved with the American Association of Gynecological Laparoscopists (AAGL), which is a society dedicated to minimally invasive gynecology, for several years now.


Uterus1: You’re on their editorial board, too, correct?


Dr. Glasser: Yes, I’ve been a reviewer for the Journal for several years and on the editorial board for the last 2 years I’ve also served on the board of trustees of the AAGL. I think it was 1977 when I did my first operative laparoscopic procedure – removal of an ectopic pregnancy. Back in the rudimentary equipment days before video cameras and monitors, it took me about 3 minutes to resect the ectopic pregnancy and another 45 minutes to get the specimen out through a 5 mm. port! This gave me the idea to use sterile plastic storage bags for specimen removal which we still use today. Most importantly, I was really fascinated by the ability to do good, essentially save someone’s life, and have her be able to go home the same day, and with a minimal amount pain. But it was not looked upon kindly when I presented the case at a grand rounds meeting at Kaiser in San Francisco. Someone got up and shouted, “Who gave you permission to do that?” The response really made no sense. We used laparoscopy for diagnostic purposes and to do tubal sterilizations, so why not use the same instruments to do the complete operation rather than open the patient’s abdomen through a 6-inch incision! It’s really taken off since then with most gynecologic surgery now able to be done in a minimally invasive way. I’ve been very active, very involved; I’ve created instruments of my own that sort of make life a little bit easier in the field as well as produced several educational videos in the field.


Uterus1: How does that process work, since there are a lot of steps go into the creation and manufacture of medical instruments?


Dr. Glasser: Well, a problem poses itself in the surgical field, and you’ll say to yourself, “If I only had something that was shaped like this, that or the other thing, I would be able to solve the problem.” I will then try to roughly sketch the idea and present it to one of the equipment companies or to an industrial engineer. If the company feels that it’s good they’ll go ahead and build it, and if not they’ll say, “Well no, this is a niche product and we can’t use it.”


Uterus1: What products have you helped to develop?


Dr. Glasser: I’ve developed a suturing needle for laparoscopic surgery called the Glasser Laparoscopic Suturing Needle, and also a very simple tumor fixation screw for laparoscopic surgery. Those are two that are in clinical use. I’ve also consulted on improving several other devices invented by others which are currently in use.


Uterus1: It must be great to feel that you’re a part of the advancement of your field in more ways than one.


Dr. Glasser: Well, it certainly does. I feel very good about the few instruments—very simple instruments—that I develop myself. And there’s not a lot of money in simple, reusable instruments, by the way. My more significant contributions have been in teaching new minimally invasive techniques through the production of surgical videos and giving lectures that ultimately benefit women.


Uterus1: But they make your job, and the jobs of others like you, easier.


Dr. Glasser: Yes, exactly. I think that’s the most important thing. And if it wasn’t for industry and the innovations that the industry has developed, I think health care in general and certainly women’s health care would not be what it is now. People would still be doing major surgery for procedures in the operating room that could be managed in the medical office.


Uterus1: To add to that, isn’t it true a lot of the most groundbreaking and important laparoscopic and minimally invasive procedures were pioneered in women’s health? It also seems that after years of ambivalence in the women’s health sector, now women may be more able to benefit from the advantage of being the first population on which these technologies were used and helping doctors develop them for general practice. What do you think?


Dr. Glasser: I agree with that. Laparoscopy was first performed in gynecology in the late ‘60s for diagnosis and tubal sterilization. Hysteroscopy was first used to view the inside of the uterus in the mid-19th century. It was not until 1976 that hysteroscopy was used to remove fibroids from inside the uterine cavity. Then in the late ‘80s, the general surgeons began doing cholecystectomies (removing the gallbladder) through the laparoscope. Now I believe that only about one percent of these procedures are done with open operations; all the rest are done laparoscopically. Arthroscopic surgery is now one of the most common procedures done in orthopedics. Knee and shoulder injuries especially, rotator cuff injuries are repaired arthroscopically using bone anchors and other materials.


Uterus1: Another one of our Body1 Heroes mentioned that he was especially excited about the growth from observation-only laparoscopy and endoscopy to tools that can do things now, and how the improvement in optic capabilities was instrumental in that. Is that something that was especially helpful to you?


Dr. Glasser: Absolutely. The ability to see, even better than you can with the naked eye, has made operative laparoscopy and hysteroscopy possible. The improvement in optics and instrumentation were paramount. In order to develop the best possible equipment that will be most useful clinically, I think it’s very important that equipment manufacturers consult with practicing physicians, especially those experts in the field of minimally invasive surgery, and ask them for their suggestions on product innovations. I think it’s to industry’s credit that they do this for the most part.


Uterus1: Do you find that process has the effect of installing an implicit set of checks and balances when it comes to ethics in marketing those products?


Dr. Glasser: It does. There are so many companies with different products. I think that it’s usually the doctor who really picks the best device which will make the surgery safer and easier for his or her patient. I don’t know how many companies have come to me with things and I’ve said, “That’s nice.” Well, “nice” is not good enough. For me to adopt a new instrument into my practice, it really must be spectacular and innovative. What you really look for is a tool that’s going to improve patient care and increase safety. That’s the bottom line.


There is, however, always the potential for conflict. This subject has been in the news recently concerning cholesterol lowering drug research. The pharmaceutical companies went to experts in the field to do the research and those experts were compensated for their time. Since the company wrote the check, there was an immediate suspicion of conflict of interest. If industry didn’t fund clinical research, it would come to a screeching halt to the detriment of all of us who need healthcare. The Women’s Health Initiative research on hormone replacement therapy was funded by Wyeth, the maker of Premarin™. Those results recommended against its use and cost Wyeth millions in sales. If the results of the study were supportive of the use of HRT, it would have been page eight news and the researchers would have been accused of bias since it was an industry-sponsored study!


Uterus1: What about the other side of that, that there are a number of law suits going on against drug companies for providing alleged kickbacks to doctors? Is the possibility of unethical behavior in the industry a drain of energy for doctors and pharmaceutical or tech companies who place a big emphasis on maintaining ethics?


Dr. Glasser: It is certainly a drain. Unfortunately, healthcare is a hugely litigious field. You try and say what you honestly believe, and what you support because of the good that device or medication will do for your patients. There are so many competing technologies, and each company has a group of doctors on their advisory board. I think doctors make a choice and determine which product they think is best for any number of reasons and then go out and support that product by encouraging others to use it. This is based on good scientific evidence as well as your own success with a particular device. It’s certainly an advantage for the manufacturer when prominent clinicians support the use of their products, but mostly I think it’s an advantage for the patient. I personally would never support a product that wasn’t safe and efficacious.


Uterus1: We talked a little about potential difficulties within doctor-tech industry relationships, but what do you think is the greatest challenge you and other people in your specialty face?


Dr. Glasser: I think the two biggest challenges we face in medicine today are the medico-legal climate and the reimbursement issues most physicians face. I am in a pretty unique position because I’ve worked for Kaiser Permanente for the last 30 years. Kaiser is most popular in California; we’ve been in the business about sixty years. It is one of the few integrated managed healthcare systems in the United States, covering about 8.5 million members. When I say “integrated system” I mean that we own our own hospitals: I’m salaried, and I work exclusively for the Permanente Medical Group which provides medical care to the Kaiser Foundation Health Plan members. It has been an advantage, because I can do for my patients what I think is right medically. The organization is very supportive in terms of equipment needs and innovative techniques. I can do minimally invasive procedures using the most modern equipment without worrying about whether or not I’ll be reimbursed. I think that’s the biggest challenge that many minimally invasive surgeons face in the country: there may be a great technology that may do the patient a tremendous amount of good, but if the insurance company or the HMO doesn’t reimburse the physician, they often wind up doing the procedure at a loss, or for less money than you’d pay your local barber. So oftentimes, physicians are forced into doing procedures in a hospital setting rather than the medical office, or totally abandoning minimally invasive procedures because of this inadequate reimbursement.


This is a good segue into HTA—HydroTherm ablation—which is a procedure that I have been doing now for a little over three years. It’s a procedure for the management of abnormal uterine bleeding which we have now done about 140 times in our office under local anesthesia. Our patients don’t even have to get into a gown. It’s almost like coming in for a Pap smear or a minor surgical biopsy. The disposable kit needed in order to do the procedure is quite expensive. The kit for HTA is less expensive than some of the other “global” ablation technologies, but nonetheless, a significant equipment expense. As I discussed above, if the insurance company does not reimburse the cost of that kit to the doctor, he or she is working at a loss. When this happens, doctors start opting to do the procedure in the surgery center or in the operating room, which will cost the healthcare system four or five times more money. So I think the greatest challenge is reimbursement for minimally invasive surgery, and I think that is the single biggest factor that can negatively affect women’s health care in the future. There are a lot of docs out there doing minimally invasive things, and as the reimbursements decrease there is no incentive to continue. So unfortunately, some people avoid performing minimally invasive alternative surgery and go ahead and perform a hysterectomy for which they get reimbursed at a much higher rate. This results in the patient undergoing a more invasive surgery with a longer recovery time and a higher complication rate, further increasing the cost to the system.


Uterus1: Do you think that establishing a dialogue with the insurance end of the health care sector about these emergent technologies is essential so that the line between “medically necessary” and “not medically necessary” procedures is a bit clearer?


Dr. Glasser: Yes, exactly. I think the insurance companies have to have people who are familiar with the technology, from the particular specialty, and in the position to make [reimbursement] decisions. It’s very hard for an internist who doesn’t know about endometrial ablation to make a decision about whether or not this procedure is appropriate. If I were a medical director of a large HMO, I wouldn’t dare to make a decision about whether to approve or not approve a coronary bypass, because it’s not my specialty. I wouldn’t feel comfortable in that position. Within the Kaiser system, it’s fortunately just the opposite, because the decisions are made by the doctors who serve on the technology committees in various specialties. That allows us to be very innovative and to provide our patients with the best care.


Uterus1: That answers the question of what makes up an ideal system. Now, for our patient readers who may have an obstetric or gynecological problem requiring a specialist in endoscopy or other non-invasive procedures, how would you recommend they go about finding a physician who can help them, and beginning a productive dialogue with that physician?


Dr. Glasser: I think there is a tremendous amount of knowledge that is available now through the Internet, and that wasn’t available ten years ago. [At Kaiser] we have individual physician, facility and departmental web sites, and we put a lot of our patient education material that comes directly from ACOG or AAGL on those websites. Industry has gone a long way in providing patient education as well. Our patients can access some of the company-produced brochures in PDF form online. [Patients] have a lot of information available to them if they take advantage of it.


I think Uterus1.com on Body1, for example, is a great site where people can get a lot of information from experts in the field. There are other sites, too. You mentioned laparoscopic or endoscopic surgery for women, and certainly the AAGL (the American Association of Gynecological Laparoscopists) has many patient education resources as well as referral services with lists of members of that organization. Certainly, if someone wants to find a laparoscopic surgeon they should look for someone who’s a member of the AAGL. Also, Body1 or Uterus1 is a place where people doing certain procedures could be listed on the web site for patients to find.


But I think a lot of patients are unaware of what’s out there. Occasionally spots will appear on television—we just did a piece on HTA that was very successful and we got many calls after that—but what gets on the air often depends on the interests of the particular producer. I think if that information is available online, coupled with a referral service—not even a service but a list, a contact list—I think that would be great. Patient education is vital, and I think patients should not be afraid to get more than one opinion. With all due respect, many of the doctors practicing out there unskilled in minimally invasive procedures will often recommend a major surgical operation, or a very complex procedure, when a simple office procedure will work just as well to improve the patient’s lifestyle. Patient awareness is vital to the advancement of endoscopic surgery. It works the other way as well: if a patient who’s been seeing a gynecologist asks for a certain procedure she has heard about, and two or three others also ask for that procedure, the doctor might be encouraged to adopt that procedure.


Uterus1: Sounds like it’s a very sanctioning-based field, with both positive and negative results.


Dr. Glasser: Oh absolutely, no question about that. And there are a lot of pieces of the puzzle involved. But what’s evolved over the course of time in the area of minimally invasive surgery is the evolution of simpler devices that can get the same, if not better, results in a much safer way. For example, in the mid-nineties we did several laparoscopic Burch procedures for urinary stress incontinence. They were very successful, but they were very time- and equipment-intensive, and very difficult to teach because the skill level required to perform the procedure was quite high. Many physicians at that time didn’t have the laparoscopic skills to do suturing. We developed this simple needle, kind of like a crochet needle which simplified that particular procedure. Still, despite intense teaching efforts, I found that there were only a few physicians who had the skills necessary to perform the procedure. A device that was developed in Europe called tension-free vaginal tape, or TVT, was FDA-approved six or seven years ago. This is extraordinarily simple technology which is more physiologic than the laparoscopic Burch, and has a much higher success rate. Also, the skill level needed to perform the procedure is much less than with the old laparoscopic procedure we were using. So I quickly adopted this procedure immediately, as did my entire department, and we haven’t done a laparoscopic Burch here in San Rafael for about four or five years. I think it’s a safer, better procedure for the patient despite the fact that I invented an instrument that was useful for the laparoscopic Burch. So things do evolve. The kit is expensive, but nonetheless if the results are better, it’s very worthwhile.


Uterus1: It must give you a huge amount of optimism about the progressive nature of your field. Even though one piece of your equipment will occasionally be rendered obsolete and one will come along to take its place, it must be good to be part of all that innovation.


Dr. Glasser: Oh, of course. And I think that’s the way things have to be. You must be able to change your way of doing things as innovations in the field occur. I’ve been zealously involved with laparoscopic surgery for a long period of time, but in the last few years, I’ve been doing a new procedure called minlaparotomy in place of many laparoscopic procedures. This procedure is performing open abdominal surgery through small, three to six centimeter incisions made easier by using an elastic, rubber retractor that gently holds the abdominal wall open during the operation. Myomectomies, supra-cervical hysterectomies and large ovarian cystectomies can be done through these very small incisions allowing the patients to go home the day of surgery and resume normal function rapidly. We’re finding that our patients are doing just about as well as those who undergo laparoscopy. Again, this is retreating from the difficult laparoscopic skills into a procedure that most board-certified gynecologists can perform using the skills they learned in residency. It’s just a matter of changing the way one thinks about surgery a little bit, and approaching each procedure in a slightly different way. I’m certainly not averse to going ahead and trying something a little differently if it’s easier, safer, and affords the same benefits to my patients.


Uterus1: Can you give another example of that in your work?


Dr. Glasser: A good example is how I’ve embraced global endometrial ablation using the HTA system, as I have. For the last 13 years, I was doing electro-surgical endometrial ablation in the OR to treat abnormal uterine bleeding. Since July of 2001 my department has used the HTA system in over 150 endometrial ablations with great success. I think the important thing in medicine, whatever the field, is to be able to embrace new technology even though it is simpler, and it may be more “boring” for the surgeon. When patient safety is of paramount concern, it’s far better to perform a simpler procedure which has fewer complications, especially when the results are comparable to what we were doing ten years ago. The problem with hysteroscopic surgery and endometrial ablation is that a lot of practicing gynecologists have not been adequately trained to perform these procedures. In fact, only about 20 percent of gynecologists even do hysteroscopy—which is an appalling figure, but that’s what is published. The usual course of events for a patient with abnormal bleeding is a trial of birth control pills, a D&C or two, which are completely useless, and then finally have a hysterectomy. Often this is done for a completely normal uterus. Endometrial ablation as an alternative to hysterectomy for abnormal bleeding and small fibroids was a phenomenal advance in women’s health care, since it’s so much less traumatic and has so many fewer complications than hysterectomy.


Global endometrial ablation techniques (ablating the entire endometrium at once) like HTA , the Thermachoice Balloon or Novasure— as well as a number of other devices,—greatly simplified endometrial ablation. Hopefully will make ablation more widely used as an alternative to hysterectomy, and decrease the hysterectomy rate in the United States, which is one of the highest in the world.


One of the reasons I chose HTA is that this is the only technique performed under direct visualization with the hysteroscope. It allows the physician to actually see what’s going on, and I think that increases the degree of safety for the patient. Even though there are other technologies now being used and in development for endometrial ablation, I don’t feel very comfortable depending on the machine to tell me that I’m in the right place when I have a technology that allows me to see what I’m doing. If you look at the complications of global ablation (and there is a very low incidence with all the techniques), you’ll see that the worst complication with HTA is vaginal burn if the saline leaks out through the cervix. With the other technologies there can be burns to the bowels resulting in colostomy, hysterectomy, and death. These have all been reported in the FDA MAUDE database.


It’s still appalling to me that in 20 percent of the hysterectomies performed in the U.S. each year, about 120,000 procedures, the patient’s only complaint is abnormal bleeding. Women must realize that undergoing a hysterectomy is not like having a manicure. There are serious complications associated with this major surgical operation including infection, bleeding, injuries to the bowel, bladder and ureters as well as death, which occurs in 1 in 10,000 cases. Also some women have serious psychological effects from having their reproductive organs removed. Hysterectomy certainly has its place in gynecology for certain conditions not amenable to more conservative alternatives, but women must be made aware that these alternatives exist and not be afraid to ask their doctor about them. I think this website goes a long way in educating people about their choices.




To read Dr. Glasser’s article about new fibroid treatment technique using HTA, please see:

The HydroThermAblator System for Management of Menorrhagia in Women with Submucous Myomas: 12- to 20-Month Follow-up
Glasser M.H.; Zimmerman J.D.
The Journal of the American Association of Gynecologic Laparoscopists, 1 November 2003, vol. 10, no. 4, pp. 521-527(7)

American Association of Gynaecological Laparoscopists

Last updated: 28-Sep-04

   
 
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