Natural Orifice Surgery

A sign of a surgical technique's potential popularity is when Jay Leno's Tonight Show features it in the comedian's monologues. Recently, Leno noted that doctors have developed no-scar surgery. “They can actually remove your gallbladder through your mouth,” Leno begins. So, he quips, “Next time you go in to see the doctor for hemorrhoids, insist, 'I'm fine, I'm fine, really!!!!!'” Jokes aside, the prospect of scarless surgery is appealing to some patients while evoking a gag reflex in others.

Natural orifice transluminal endoscopic surgery ' often referenced by the acronym NOTES ' is becoming increasingly popular. One reason: NOTES may reduce the risks of infection. While the popular press often refers to the technique as “scarless surgery,” the term “scarless” may be a misnomer. Rather, surgeons make incisions in areas that are not visible to the outside of the body. Incisions are made inside the body's cavity to gain access to the organ that is the focus of the procedure. From a cosmetic standpoint, no one viewing the outside of the patient's body would see an incision. Physicians may be able to remove organs or tissues through the vagina, mouth or anus after gaining access to the body's inner cavity through minimally invasive surgery.

NOTES reduces some types of risks that are inherent in conventional surgery. These risks are wound infections, adhesions, hernias, postoperative abdominal wall pain and possible compromised immune systems. Chief candidates for scarless surgery would include patients who are morbidly obese, critically ill, or other patients at high risk for conventional surgery. While there are benefits from scarless surgery, there are also areas of potential liability.

Potential Avenues of Liability Claims

In foreshadowing the types of liability claims practitioners might expect from the popularization of NOTES, we may look to the experiences of those practicing another niche of cutting-edge medicine, the realm of minimally invasive joint-replacement surgery. Such surgeries are increasingly popular, for many of the same reasons that make NOTES appealing: less visible scarring, compressed recovery time, lower costs and briefer hospital stays. However, some concerns have been expressed about the safety of minimally invasive joint replacement procedures. “New Doubts About Popular Joint Surgery,” The Wall Street Journal, 10/14/08. These stem from:

• Surgeons working with less visibility, due to smaller incisions;
• Rapid growth in the technique, which creates situations where doctors lacking extensive experience are doing these complicated procedures; and
• Over-promotion and “hyping” of patient expectations.

As with minimally invasive joint-replacement surgery, over-promotion of NOTES by doctors is one potential liability hot spot. Some patients with less than perfect outcomes may accuse doctors of overzealousness ' using patients as guinea pigs. This scenario becomes more likely if patients can prove that conventional surgery would have posed less risk for injury to areas adjacent to the surgical site.

NOTES has clinical benefits, but it also has risks. From those risks one can envision various patient claims in medical malpractice lawsuits. Avenues of possible liability arguments and claims might include:

• Poor patient selection: The patient was unsuited for the surgery due to condition, medical history or other factors;
• Inadequate informed consent: The patient was not fully briefed on the potential risks and side-effects of the procedure, or was not told that the procedure was quasi-experimental;
• Post-operative infection: Just because an incision is not visible externally does not mean that internal incisions are infection-free. Post-op infections can still occur; when and if they do, patients may sue the doctor or hospital for negligently managing the care;
• Product liability: A patient might bring a product liability claim against the manufacturer of a surgical tool. Whenever a new form of surgery becomes popular, enterprising medical equipment companies see a new market. Accordingly, they develop new and customized tools to facilitate performing specialized procedures. NOTES will likely be no exception and will have companies developing surgical tools for this new niche.

Part of the challenge of scarless surgery is the fact that many of the most accomplished gastroenterologists may lack refined surgical skills. Further, the most accomplished surgeons may lack the endoscopic skills necessary to perform scarless surgery procedures. Gastroenterologists performing scarless surgery might be challenged to address intra-abdominal complications, which could be life-threatening. These include perforation, bleeding, and organ damage.

Frederick Green, chairman of the department of surgery at Charlotte, NC's Carolinas Medical Center, has written, “It's totally senseless to put a hole in a perfectly good organ.” He notes that if the surgeon fails to properly close the stomach wall during natural orifice surgery, bacteria and acid can leak into the abdominal cavity. This can be a medical emergency. Removing organs vaginally poses potential complications too, as concerns exist that cutting the vaginal wall could leave scars or infections that compromise later attempts at fertility.

Using carbon dioxide to inflate the abdominal cavity may create complications that could spawn claims and lawsuits. Dr. Green observes that NOTES procedures risk infection. Since doctors must inflate patients with carbon dioxide to create space within which to operate, an internal incision can become an avenue of infection for organisms to spread. Such organisms that would normally be relatively confined could be blown throughout the abdominal cavity. “Gallbladder Out, No Incision Required,” US News & World Report, 10/13-20, 2008, pp. 68-70.

Medical Device Company Liability

If an adverse patient outcome results from a NOTES procedure, potential defendants could include not only the doctor performing the procedure, but the makers of any devices whose performance is suspected as having a role in the outcome. Allegations of product defect during NOTES procedures could result in a straight product liability claim or a blended complaint alleging both product liability and medical malpractice.

Medical device firms rushing to occupy this niche and entering the market might face allegations of over-promotion. One market entrant, Endo-Gastric Solutions, states in a 5/16/08 press release that, “NOS procedures are relatively simple and easy to perform.” The release also states that “the technology is safe ' ” These statements may be accurate, but their veracity and precision will likely be challenged by attorneys in the event of any adverse patient outcome, with plaintiff counsel likely to allege over-promotion and hyping of the new surgical technology.

Likely Defense Themes

Peeking over the horizon and anticipating that any new area of medicine will spawn new areas of litigation and liability, likely defense themes are not likely to look novel to the medical malpractice attorney. These avenues might include:

• A Bad Outcome Does Not Equal Negligence: This common theme in medical malpractice cases is no different when the suspect procedure involves NOTES. “The post-op complication was an inherent risk of the surgical procedure,” a defendant's attorney might argue, or, “The doctor's technique represented reasonable care and competence, if not better.”
• Informed Consent: The patient was informed of the potential risks before the NOTES procedure and knowingly consented to it, having weighed the benefits versus the risks.
• Intervening Cause: The patient's adverse outcome was due to an intervening cause that had nothing to do with the surgeon's technique or competence, but rather to an intervening cause outside the doctor's control. An example would be the malfunction or a defect in one of the devices used for the NOTES procedure.
• Patient Disregard of Instructions: The patient's adverse outcome was due to the patient's own non-compliance with the recommended post-operative regimen.

We may anticipate that physicians, health-care facilities, medical malpractice insurance claim representatives and defense attorneys will build on these themes. Like the framing structure of a house, these themes may provide the structure around which lawyers can construct effective defenses of professionals and facilities facing claims and lawsuits over so-called scarless surgery.

Risk-Management Strategies for Physicians and Health-care Entities

One way to avoid lawsuits, claims and courtrooms is for medical practitioners to invest in sound risk-management strategies. Four such strategies straddle the continuum between promising and impractical.

Avoidance

Avoidance as a clinical risk management tool means not engaging in activities that give rise to a risk. One way to avoid claims and lawsuits from NOTES is to make a conscious decision not to engage in this surgical technique. This may be a tall order, though, especially for surgeons and other doctors who are intrigued by the clinical approach. Add to that an increasingly enthusiastic population of patients who read about “scarless” surgery in weekly news magazines and periodicals, and the temptation to try this type of surgery can be powerful and outweigh risk-management considerations. Doctors who refuse to perform NOTES might lose patients ' and income ' to competing physicians who perform such surgery.

A modified form of avoidance might be for doctors to decide that they will only perform scar-less surgery when: 1) the technique has been “fire-tested” clinically for safety and efficacy; and/or 2) they have a greater degree of hands-on training in the technique. Such physicians would simply be deferring their practice of these procedures, rather than avoiding them altogether. Surgeons constantly seek ways to perform procedures better, faster and safer. In a clinical context, foregoing NOTES to “avoid” professional liability claims is like having the risk “tail” wag the “dog.”

Retention

As a risk management tool, retention involves self-funding for future losses, and not transferring the financial consequence of loss to a third party. Some corporations may self-insure, setting aside money they would otherwise pay in insurance premiums and placing such funds in an account from which to fund future losses. Another way that policyholders practice retention is by shouldering deductibles or self-insured retentions. While these may be realistic options for first-party property losses, they have little relevance for professional liability exposures. A surgeon performing NOTES procedures might opt to “go bare” by forgoing insurance, but this would be tantamount to playing Russian Roulette with a practitioner's (and patient's) financial health. One uninsured claim could exceed or exhaust a physician's financial assets.

Loss Control

Perhaps the most viable risk management technique for addressing potential liability exposures from NOTES procedures lies in loss control. Loss control aims to reduce the frequency and severity of losses. In the context of scarless surgery, loss control measures might include:

• Staying current on the optimum surgical techniques involved in NOTES and vigorously pursuing continuing medical education programs;
• Practicing “intelligent” patient selection, to make sure that only those patients whose pre-surgery conditions are most amenable to NOTES are offered the procedures; and
• Obtaining meticulous informed consent, with time invested up-front with patients to explain the benefits and potential risks of NOTES procedures, and to calibrate patient expectations. It will be important for the doctors not only to obtain documentation of good informed consent, but also to document discussions as to treatment choices and their pros and cons.

Insurance Contractual Transfer

Physicians performing scarless surgery procedures will need the protection of professional liability insurance (medical malpractice) coverage. Practitioners should be able to procure such coverage, but it may be at premium prices, higher than what they would like to pay. Time will tell how insurance underwriters view the attractiveness of this feature in a physician's practice and repertoire of techniques. Some underwriters may rate this as a “safer” niche due to the quicker post-op recovery times and the minimally invasive aspect of the procedure. Other underwriters may be wary of NOTES due to its quasi-experimental nature and the fact that it may be too soon to fully assess all the complications that could result from its popularization. One clue as to an insurer's attitude toward the surgery may be if insurance applications ask specifically whether the doctor performs NOTES procedures. This could be a tip-off that the insurer views the technique as a risk factor and may either rate-up the policy or decline to quote coverage.

Conclusion

Medically, the NOTES genie is out of the bottle and unlikely to go back in. Further refinements and innovations in this surgical subspecialty are underway. Researchers are developing a natural orifice “I-snake” camera and surgical system that would obviate the need for any incisions. Oral and rectal access systems may be ready for testing within four years. One U.S. firm is testing a stomach stapler for obese patients that slides down the throat instead of needing abdominal surgery.

In writing on the subject of risk and NOTES, I do not mean to say that natural orifice surgery is an inherently dangerous therapy, hazardous or something that patients should avoid. Conventional surgery entails risks too; every surgery has risks. Decisions to forgo surgery also carry risks. Rather, this discussion identifies potential risks and complications that likely will not retard the development or exploration of natural orifice surgery. Identifying potential complications and adverse outcomes can arm healthcare institutions and professionals ' and the attorneys who represent them ' with strategies for addressing them. These strategies may play out in the courtroom. Other strategies can be implemented as part of a risk management plan that may render the courtroom an even more unlikely destination for cases involving adverse outcomes.

Soldiers in training have a saying, “The more you sweat in practice ' the less you bleed in battle.” Similarly, the more practitioners and health-care entities sweat the details by investing in sound risk management, the less they may “bleed” in legal costs, settlements and adverse jury judgments.

Kevin Quinley, CPCU, a member of this newsletter's Board of Editors, is an insurance claim expert, consultant and author of 'Bulletproofing Your Medical Practice' (SEAK, Inc.).

A sign of a surgical technique's potential popularity is when Jay Leno's Tonight Show features it in the comedian's monologues. Recently, Leno noted that doctors have developed no-scar surgery. “They can actually remove your gallbladder through your mouth,” Leno begins. So, he quips, “Next time you go in to see the doctor for hemorrhoids, insist, 'I'm fine, I'm fine, really!!!!!'” Jokes aside, the prospect of scarless surgery is appealing to some patients while evoking a gag reflex in others.

Natural orifice transluminal endoscopic surgery ' often referenced by the acronym NOTES ' is becoming increasingly popular. One reason: NOTES may reduce the risks of infection. While the popular press often refers to the technique as “scarless surgery,” the term “scarless” may be a misnomer. Rather, surgeons make incisions in areas that are not visible to the outside of the body. Incisions are made inside the body's cavity to gain access to the organ that is the focus of the procedure. From a cosmetic standpoint, no one viewing the outside of the patient's body would see an incision. Physicians may be able to remove organs or tissues through the vagina, mouth or anus after gaining access to the body's inner cavity through minimally invasive surgery.

NOTES reduces some types of risks that are inherent in conventional surgery. These risks are wound infections, adhesions, hernias, postoperative abdominal wall pain and possible compromised immune systems. Chief candidates for scarless surgery would include patients who are morbidly obese, critically ill, or other patients at high risk for conventional surgery. While there are benefits from scarless surgery, there are also areas of potential liability.

Potential Avenues of Liability Claims

In foreshadowing the types of liability claims practitioners might expect from the popularization of NOTES, we may look to the experiences of those practicing another niche of cutting-edge medicine, the realm of minimally invasive joint-replacement surgery. Such surgeries are increasingly popular, for many of the same reasons that make NOTES appealing: less visible scarring, compressed recovery time, lower costs and briefer hospital stays. However, some concerns have been expressed about the safety of minimally invasive joint replacement procedures. “New Doubts About Popular Joint Surgery,” The Wall Street Journal, 10/14/08. These stem from:

• Surgeons working with less visibility, due to smaller incisions;
• Rapid growth in the technique, which creates situations where doctors lacking extensive experience are doing these complicated procedures; and
• Over-promotion and “hyping” of patient expectations.

As with minimally invasive joint-replacement surgery, over-promotion of NOTES by doctors is one potential liability hot spot. Some patients with less than perfect outcomes may accuse doctors of overzealousness ' using patients as guinea pigs. This scenario becomes more likely if patients can prove that conventional surgery would have posed less risk for injury to areas adjacent to the surgical site.

NOTES has clinical benefits, but it also has risks. From those risks one can envision various patient claims in medical malpractice lawsuits. Avenues of possible liability arguments and claims might include:

• Poor patient selection: The patient was unsuited for the surgery due to condition, medical history or other factors;
• Inadequate informed consent: The patient was not fully briefed on the potential risks and side-effects of the procedure, or was not told that the procedure was quasi-experimental;
• Post-operative infection: Just because an incision is not visible externally does not mean that internal incisions are infection-free. Post-op infections can still occur; when and if they do, patients may sue the doctor or hospital for negligently managing the care;
• Product liability: A patient might bring a product liability claim against the manufacturer of a surgical tool. Whenever a new form of surgery becomes popular, enterprising medical equipment companies see a new market. Accordingly, they develop new and customized tools to facilitate performing specialized procedures. NOTES will likely be no exception and will have companies developing surgical tools for this new niche.

Part of the challenge of scarless surgery is the fact that many of the most accomplished gastroenterologists may lack refined surgical skills. Further, the most accomplished surgeons may lack the endoscopic skills necessary to perform scarless surgery procedures. Gastroenterologists performing scarless surgery might be challenged to address intra-abdominal complications, which could be life-threatening. These include perforation, bleeding, and organ damage.

Frederick Green, chairman of the department of surgery at Charlotte, NC's Carolinas Medical Center, has written, “It's totally senseless to put a hole in a perfectly good organ.” He notes that if the surgeon fails to properly close the stomach wall during natural orifice surgery, bacteria and acid can leak into the abdominal cavity. This can be a medical emergency. Removing organs vaginally poses potential complications too, as concerns exist that cutting the vaginal wall could leave scars or infections that compromise later attempts at fertility.

Using carbon dioxide to inflate the abdominal cavity may create complications that could spawn claims and lawsuits. Dr. Green observes that NOTES procedures risk infection. Since doctors must inflate patients with carbon dioxide to create space within which to operate, an internal incision can become an avenue of infection for organisms to spread. Such organisms that would normally be relatively confined could be blown throughout the abdominal cavity. “Gallbladder Out, No Incision Required,” US News & World Report, 10/13-20, 2008, pp. 68-70.

Medical Device Company Liability

If an adverse patient outcome results from a NOTES procedure, potential defendants could include not only the doctor performing the procedure, but the makers of any devices whose performance is suspected as having a role in the outcome. Allegations of product defect during NOTES procedures could result in a straight product liability claim or a blended complaint alleging both product liability and medical malpractice.

Medical device firms rushing to occupy this niche and entering the market might face allegations of over-promotion. One market entrant, Endo-Gastric Solutions, states in a 5/16/08 press release that, “NOS procedures are relatively simple and easy to perform.” The release also states that “the technology is safe ' ” These statements may be accurate, but their veracity and precision will likely be challenged by attorneys in the event of any adverse patient outcome, with plaintiff counsel likely to allege over-promotion and hyping of the new surgical technology.

Likely Defense Themes

Peeking over the horizon and anticipating that any new area of medicine will spawn new areas of litigation and liability, likely defense themes are not likely to look novel to the medical malpractice attorney. These avenues might include:

• A Bad Outcome Does Not Equal Negligence: This common theme in medical malpractice cases is no different when the suspect procedure involves NOTES. “The post-op complication was an inherent risk of the surgical procedure,” a defendant's attorney might argue, or, “The doctor's technique represented reasonable care and competence, if not better.”
• Informed Consent: The patient was informed of the potential risks before the NOTES procedure and knowingly consented to it, having weighed the benefits versus the risks.
• Intervening Cause: The patient's adverse outcome was due to an intervening cause that had nothing to do with the surgeon's technique or competence, but rather to an intervening cause outside the doctor's control. An example would be the malfunction or a defect in one of the devices used for the NOTES procedure.
• Patient Disregard of Instructions: The patient's adverse outcome was due to the patient's own non-compliance with the recommended post-operative regimen.

We may anticipate that physicians, health-care facilities, medical malpractice insurance claim representatives and defense attorneys will build on these themes. Like the framing structure of a house, these themes may provide the structure around which lawyers can construct effective defenses of professionals and facilities facing claims and lawsuits over so-called scarless surgery.

Risk-Management Strategies for Physicians and Health-care Entities

One way to avoid lawsuits, claims and courtrooms is for medical practitioners to invest in sound risk-management strategies. Four such strategies straddle the continuum between promising and impractical.

Avoidance

Avoidance as a clinical risk management tool means not engaging in activities that give rise to a risk. One way to avoid claims and lawsuits from NOTES is to make a conscious decision not to engage in this surgical technique. This may be a tall order, though, especially for surgeons and other doctors who are intrigued by the clinical approach. Add to that an increasingly enthusiastic population of patients who read about “scarless” surgery in weekly news magazines and periodicals, and the temptation to try this type of surgery can be powerful and outweigh risk-management considerations. Doctors who refuse to perform NOTES might lose patients ' and income ' to competing physicians who perform such surgery.

A modified form of avoidance might be for doctors to decide that they will only perform scar-less surgery when: 1) the technique has been “fire-tested” clinically for safety and efficacy; and/or 2) they have a greater degree of hands-on training in the technique. Such physicians would simply be deferring their practice of these procedures, rather than avoiding them altogether. Surgeons constantly seek ways to perform procedures better, faster and safer. In a clinical context, foregoing NOTES to “avoid” professional liability claims is like having the risk “tail” wag the “dog.”

Retention

As a risk management tool, retention involves self-funding for future losses, and not transferring the financial consequence of loss to a third party. Some corporations may self-insure, setting aside money they would otherwise pay in insurance premiums and placing such funds in an account from which to fund future losses. Another way that policyholders practice retention is by shouldering deductibles or self-insured retentions. While these may be realistic options for first-party property losses, they have little relevance for professional liability exposures. A surgeon performing NOTES procedures might opt to “go bare” by forgoing insurance, but this would be tantamount to playing Russian Roulette with a practitioner's (and patient's) financial health. One uninsured claim could exceed or exhaust a physician's financial assets.

Loss Control

Perhaps the most viable risk management technique for addressing potential liability exposures from NOTES procedures lies in loss control. Loss control aims to reduce the frequency and severity of losses. In the context of scarless surgery, loss control measures might include:

• Staying current on the optimum surgical techniques involved in NOTES and vigorously pursuing continuing medical education programs;
• Practicing “intelligent” patient selection, to make sure that only those patients whose pre-surgery conditions are most amenable to NOTES are offered the procedures; and
• Obtaining meticulous informed consent, with time invested up-front with patients to explain the benefits and potential risks of NOTES procedures, and to calibrate patient expectations. It will be important for the doctors not only to obtain documentation of good informed consent, but also to document discussions as to treatment choices and their pros and cons.

Insurance Contractual Transfer

Physicians performing scarless surgery procedures will need the protection of professional liability insurance (medical malpractice) coverage. Practitioners should be able to procure such coverage, but it may be at premium prices, higher than what they would like to pay. Time will tell how insurance underwriters view the attractiveness of this feature in a physician's practice and repertoire of techniques. Some underwriters may rate this as a “safer” niche due to the quicker post-op recovery times and the minimally invasive aspect of the procedure. Other underwriters may be wary of NOTES due to its quasi-experimental nature and the fact that it may be too soon to fully assess all the complications that could result from its popularization. One clue as to an insurer's attitude toward the surgery may be if insurance applications ask specifically whether the doctor performs NOTES procedures. This could be a tip-off that the insurer views the technique as a risk factor and may either rate-up the policy or decline to quote coverage.

Conclusion

Medically, the NOTES genie is out of the bottle and unlikely to go back in. Further refinements and innovations in this surgical subspecialty are underway. Researchers are developing a natural orifice “I-snake” camera and surgical system that would obviate the need for any incisions. Oral and rectal access systems may be ready for testing within four years. One U.S. firm is testing a stomach stapler for obese patients that slides down the throat instead of needing abdominal surgery.

In writing on the subject of risk and NOTES, I do not mean to say that natural orifice surgery is an inherently dangerous therapy, hazardous or something that patients should avoid. Conventional surgery entails risks too; every surgery has risks. Decisions to forgo surgery also carry risks. Rather, this discussion identifies potential risks and complications that likely will not retard the development or exploration of natural orifice surgery. Identifying potential complications and adverse outcomes can arm healthcare institutions and professionals ' and the attorneys who represent them ' with strategies for addressing them. These strategies may play out in the courtroom. Other strategies can be implemented as part of a risk management plan that may render the courtroom an even more unlikely destination for cases involving adverse outcomes.

Soldiers in training have a saying, “The more you sweat in practice ' the less you bleed in battle.” Similarly, the more practitioners and health-care entities sweat the details by investing in sound risk management, the less they may “bleed” in legal costs, settlements and adverse jury judgments.

Kevin Quinley, CPCU, a member of this newsletter's Board of Editors, is an insurance claim expert, consultant and author of 'Bulletproofing Your Medical Practice' (SEAK, Inc.).