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New surgical procedures: should I or shouldn't I?

An Opportunity to Improve Care

As physicians and surgeons who are committed to clinical excellence, we carry an obligation to bring advances in the medical sciences to our communities as soon as possible. We currently live and practice medicine during a time of rapid change. In order to be better surgeons for tomorrow's patients, we need to constantly assess and refine what we do today. The members of the Society of Gynecologic Surgeons are looked upon by patients and other doctors as leaders in the world of reconstructive vaginal surgery. We are expected to be pioneers.

We come to meetings not to feel better about the procedures that we have done or are currently doing, but to become better through the process of adopting new techniques to fill an unmet need or to replace a procedure we are beginning to feel discouraged about.

I do think we need to look at everything that comes along with a critical eye. It is our challenge and responsibility to use our intellectual resources and our network of colleagues to examine preliminary level III evidence and clinical experience to decide when and how to adopt a new procedure. It does not give us license to try every new procedure that comes to market just for the sake of trying it, or to switch from a procedure that is working well for us to a competing technology simply because we stand to benefit from it.

As they say in fishing, you don't leave fish to find fish. If you're happy with tension-free vaginal tape (TVT) to treat stress urinary incontinence (SUI), don't change to transobturator tape (TOT) unless it fills an unmet need. But just as we should critically evaluate any new idea, it is also important that we critically evaluate ourselves, what we think we do well, and what we could do better.

The need for innovation is evident in the history of surgical procedures for SUI. A surgical attempt to correct SUI was first described in 1864, followed by a report in 1888 on a large series of patients treated surgically with a vaginal anterior repair. Fast forward to 1994, when the TVT procedure was first described in Stockholm, and 1998, when TVT was approved for use in the United States. In those 110 years between that report in 1888 and the adoption of TVT in the U.S., approximately 200 operations were described for the treatment of SUI. That averages out to 1.8 new procedures per year. Therefore, changes in surgical technique are our past, present, and future.

For 13 years of clinical practice, I performed Burch procedures as my surgical technique of choice for treating SUI, and sacrospinous ligament suspensions for vaginal vault prolapse. Fortunately, my complication rate has been low and my failure rate predictable. However, I have always felt there was excessive impairment during my patients' postoperative recovery. When a new procedure offers similar efficacy with substantially decreased postoperative convalescence, it provides us the opportunity to improve care for our patients. At the end of the day, that's the only thing that matters to me.

Over the years, I have found that many of my patients are willing to be risk takers when offered a choice between a new approach and a traditional procedure with consistent but less satisfactory outcomes. Patients seek me out because I can offer them a wide variety of treatment options, including newer therapies.

Of course, I don't subscribe to a "monkey see, monkey do" philosophy. Drilling holes in the pubis and sticking in bone anchors seemed to me like a bad idea from the start. But that's why we draw on our intellect and experience to guide us. I don't think we need to wait for major studies to be completed to decide that a new procedure makes sense and could improve patient outcomes.

While I believe clinical research is important to help us refine the care that we deliver, I submit that clinical research rarely dictates everyday care. Even in the presence of very strong data to support a new technique, physicians are very reluctant to change the way they practice.

How many trials do we have in obstetrics showing that tocolytics have limited efficacy, or that the efficacy of steroids and antibiotics is extremely limited in the management of preterm labor? Yet many obstetricians continue to practice the same way they have practiced for years and decades, despite new evidence that suggests treatment protocols should change.

The design of research studies also rarely approximates the environment in which we practice. Clinical research highlights small but measurable differences in very large populations, whereas in clinical medicine we make decisions based on the needs, expectations, and concerns of one patient.

The problem with a watch-and-wait approach is that it means many women in the community will fail to realize the benefit of new and promising techniques for years. In my opinion, that is not acceptable. There are times when we must be willing to take calculated risks when we see an opportunity for improvement.

DR. MARC TOGLIA directs Urogynecology Associates of Philadelphia and also serves as chief of gynecology at Riddle Memorial Hospital in Media, Pa.

A Disservice to Our Patients

I'd love to come to meetings and see level III data outlining the efficacy and safety of new procedures using new devices. But we have a big problem with new devices in the United States. They can be pushed onto the market with basically no data at all.

If you want Food and Drug Administration approval for a drug, you have to go through a very rigorous process, proving in phase I, II, and III clinical trials that the drug is safe, more efficacious than placebo, and that you know the appropriate dosage. All you have to do to get approval for a device is to show that it's substantially equivalent to some other device on the market, using a very loose interpretation of "equivalent." Why is our system so rigorous about a drug that you excrete in 24 hours, yet so casual about something permanently implanted in your body?

Any new device introduced in the United Kingdom must go through the Evidence-Based Medicine Council. You can't perform a TOT procedure in the U.K. today because that group has looked at the data and doesn't think there is substantial evidence to justify its use at this point.

You can go to a booth down the hall from any surgical meeting today in the U.S. and find devices for sale in the absence of any data that they are efficacious, safe, or even backed by decent outcomes data. Some just have animal data. To me, this means you should be very, very skeptical about these products and it also means you shouldn't be the first to do these surgical procedures.

History is full of examples of new surgical techniques gone wrong. There's an initial excitement phase. Everyone is enthusiastic. Then we get the data, and in many cases, the procedure fades into oblivion. Whenever this happens, we have done a disservice to our patients.

An example is the ProteGen sling, a wonderful-looking device made of woven polyester covered with collagen. It turns out to be woven multifilament, a sanctuary for bacteria. If you wouldn't put a Dalkon Shield IUD with a multifilament tail into a woman, why would you put in a multifilament graft?

TVT is a wonderful procedure. It's been around since 1994. I began to adopt it in 1999 after I saw reasonable data. I think that's the best approach: wait and see the data before you adopt.

One problem with the "essentially equivalent" standard for FDA device approval is that people take products backed with data and make revisions backed by no data. They take TVT known to be efficacious and implant biologic material in the middle of it and market it up and down. What happens in 3 months is that you have a TVT that's been cut. Now we're seeing about a 50% success rate with transected TVTs.

Every sportsman and sportswoman loves Gore-Tex because it's waterproof and breathable. Now tell me, why does the vagina need something waterproof and breathable? It's just another multifilament that gets infected--one study shows 30% infection rates and 22% removal rates.

What about radiofrequency ablation of periurethral tissues? Let's take nice healthy tissue next to the urethra--filled with beautiful muscle, beautiful connective tissue, a nerve supply--and let's just fry it and create scar tissue. Early studies showed that after 12 months, only 23% of women who received RF ablation had no daily incontinence episodes. Nearly 50% of women were still wearing pads. Kegel exercises do better than that without destroying a bit of healthy tissue.

Another example: urethral bulking injections. You can use collagen, fat, silicone particles, Teflon, carbon-coated microspheres, dextranomer/hyaluronic acid mixtures, calcium hydroxyapatite, porcine dermal grafts. How many of these have been shown to be more effective or durable than collagen? None.

If you use something that's inert instead of biodegradable, aren't you likely to see more complications? Didn't we learn about the rejection of foreign materials in medical school?

What's popular now is polypropylene mesh for the anterior vagina, the posterior vagina, as a replacement for the whole vagina. They say it shrinks 20%. What if it shrinks more than 20%? People are advocating putting these in 35-year-old women. Do we really know how that vagina is going to function in a 55- or 60-year-old, sexually active woman?

In my community, I see physicians jumping on every new bandwagon. I don't think they'd jump so quickly if they understood that FDA device approval means absolutely nothing.

If you're a CEO and you're making a graft, what's the best use of your money? To go to market and hire cute reps and get everyone in the community to use it, or to fund expensive studies the FDA doesn't require? You do the former.

We can let anyone market anything, become early adopters of new technology, and only later find out the complications.

Or we can stand up and just say no; we can insist on well-done studies, whether the FDA requires them or not.

DR. CHARLES W. NAGER is professor of clinical reproductive medicine and director of the division of urogynecology at University of California San Diego Medical Center.

Dr. Toglia and Dr. Nager debated this topic at the annual meeting of the Society of Gynecologic Surgeons in Tucson, Ariz.
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Author:Toglia, Marc; Nager, Charles W.
Publication:OB GYN News
Date:Jun 15, 2006
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