Avoiding legal pitfalls of hysteroscopy
Attorneys and Ob/Gyns trade views on informed consent, documentation, and other vulnerable areas.
IN THIS ARTICLE
- Managing and minimizing operative complications
Over the course of our careers, at least 75% of Ob/Gyns will have 1 or more medical liability claims filed against us. This naturally makes us cautious, sometimes overly so.
Though hysteroscopy is usually an effective—as well as safe—alternative to hysterectomy, many Ob/Gyns have not yet integrated this technology routinely into patient care, partly because of the fear of litigation.
In this roundtable, legal and medical experts comment on ways to minimize legal risks in 3 hypothetical cases.
OUR EXPERT PANELISTS
- Steven R. Lindheim, MD, moderator, is associate professor, department of obstetrics and gynecology, University of Wisconsin Medical School, Madison
- Daniel Williams, MD, is associate professor, department of obstetrics and gynecology, University of Cincinnati College of Medicine
- Ira Newman, Esq, is an attorney at Sanocki, Newman, Turret, LLP, New York City
- Eric H. Weitz, Esq, is an attorney at Layser & Freiwald, PC, Philadelphia
- Jerry A. Lindheim, Esq, is an attorney at Locks Law Firm, Philadelphia
Case 1: fluid overload
“Abby” is a 30-year-old nulligravida who presents with menometorrhagia and symptomatic anemia. Sonohysterography reveals a 3-cm submucous fibroid. After 3 months of pretreatment with a GnRH agonist to decrease the size of the fibroid and relieve her anemia, Abby undergoes hysteroscopic resection of the fibroid with a monopolar instrument and 1.5% glycine as the distention medium. The surgery is prolonged, and the fluid deficit at the end of the case is 1,700 mL.
Serial labs are drawn in the recovery room, and Abby is hospitalized overnight for observation. Her fluid intake is restricted and a diuretic is administered. The next day her electrolytes are normal, and she is discharged from the hospital.
When assessing clinical risk, watch fluid deficit, large myomas
DR. LINDHEIM: Clinically speaking, the choice of distention fluid in this case is appropriate, since the surgeon is using monopolar electrical current, and glycine has low molecular viscosity. However, it is imperative to strictly monitor the fluid deficit and, whenever possible, limit infusion pressure to 60 to 75 mm Hg and keep operating time below 1 hour.
Also be aware that larger submucosal myomas may have sizeable venous channels. When these channels are opened during resection, significant fluid intravasation can result.
Should a physician say “I’m sorry”?
Dr. Lindheim:As a front-page article in the Wall Street Journal8 observed, a doctor’s best tool in fighting lawsuits may simply be owning up to errors. Yet this concept has been somewhat taboo in the medical community. What are your thoughts on a physician giving a simple apology?
Mr. Lindheim: It is in the heat of passion, usually involving anger, that families seek vindication against a physician simply because the physician wasn’t nice or failed to address questions posed by the family about an unfortunate outcome. In everyday life, when emotion clouds reason, it is hard to think logically and understand complex explanations. When a physician comes across as arrogant at such a time, the patient and her family are often motivated to contact an attorney to evaluate the standard of care.
Of course, an unfortunate outcome is not always the result of medical negligence. This is difficult to explain to a family angered by a doctor’s “attitude.” An apology may somewhat soothe the anger that drives many lawsuits, but it may not be enough to deflect litigation unless the physician is prepared to take responsibility for the adverse outcome.
Mr. Newman: Patients usually seek the advice of a lawyer out of anger or mistrust. They may believe their doctor has been evasive or inaccessible.
In cases where medical negligence may have caused injury to the patient, or complications associated with the nature of the procedure result in injury, it is my opinion that the treating doctor should forthrightly address any questions and concerns the patient has. This includes making oneself available in person or by telephone on a daily basis. In fact, picking up the phone and calling a patient who feels “wronged” may be the single most effective tool the doctor has to prevent a medical malpractice lawsuit.
Complications associated with glycine solution include water intoxication with hypervolemia and hyponatremia. Once a fluid deficit reaches 750 mL, the surgeon should check electrolytes, give a diuretic, and complete the procedure as soon as possible. When deficits exceed 1,500 mL, stop the procedure immediately (assuming adequate hemostasis) and give another diuretic.
Managing water intoxication
Treating patients with water intoxication involves removing excess fluid and correcting serum sodium levels.
Some experts have argued the case for expectant management, which consists of water restriction and spontaneous diuresis. Others counter that patients with severe hyponatremia warrant immediate therapy, since they can deteriorate rapidly with little warning of seizures and respiratory arrest.
Legal outlook: Informed consent, thorough documentation are key
MR. LINDHEIM: I assume a proper informed consent document has been signed. Only the risks and complications listed on that document can be assumed to have the patient’s consent.
To avoid a claim associated with the consent process, the form should describe the exact procedure and alternatives, as well as the potential risks and complications, and it should be signed by the patient. Remember that informed consent is not just the physician’s recitation of this information, but the patient’s articulation of her understanding in response.
In this case, the facts surrounding all events should be well documented. The OR nurse should record the time, amount, and concentration of distention media given, preferably initialized by the person actually administering the medium. If this is not possible, the nurse should note that she was present at the time of administration and observed the medium being given. If a nurse or physician is later asked to explain what medications or fluids were administered, and this information was not documented, it opens the door to fanciful speculation on their part and cross-examination by the plaintiff’s attorney.
FIGURE Which complications are most common? Bleeding and perforation lead the pack, but others warrant vigilance, too
Do not attempt to insert these entries later. Handwriting specialists and other experts can detect when a record has been altered. Never try to change entries or erase them—by hand or using correction fluid. The chart is the first thing the plaintiff’s attorney will request and receive once a suit is initiated. Tampering with it is a surefire way to incur punitive damages.
Since this patient was kept for observation, the reasons for doing so may warrant an entry (eg, to monitor fluid intake and output [I/O]). If serial labs are drawn, each one should find its way into the chart.
Thorough recordkeeping is essential. Any time an item is lost or not included, the plaintiff’s attorney will argue that something is being hidden. Fluid levels are just as important as lab studies. Make sure the I/O chart is properly filled in, especially when fluid overload could give rise to litigation. These I/O sheets and medication (diuretic) forms should include the time of each assessment or administration.
Key ingredients of informed consent
DR. WILLIAMS: Could you describe an adequate informed consent form?
MR. LINDHEIM: In general, the body of the document should list all benefits and risks of the procedure, including anesthetic risk, infection, injury to organs and the need to repair them surgically, fluid overload and specific complications related to the type of distention media to be used, air emboli and their treatment, and long-term complications such as scarring and infertility.
Consent forms are usually signed at the end of the document, but you may want to insert a line next to each risk for initialing or signing by the patient, as well as a witnessing line at the end. This would make it clear the patient agreed to the procedure and was aware of all benefits and risks, and would present a strong defense to a later claim of lack of consent. I also recommend a notation in the progress records reemphasizing the consent process.
Provide patient-education articles
MR. WEITZ: Another effective technique is to mail or provide the woman with patient-oriented articles about the procedure and risks. Since most patients undergo hysteroscopy on a scheduled basis rather than emergently, they have an opportunity to read these articles before signing the consent form. Reference to these materials in the form is also an effective way to minimize medicolegal risk.
Factors leading to litigation
DR. LINDHEIM: Under what conditions would a legal action be initiated?
MR. WEITZ: All negligence claims require 4 elements:
- duty arising out of the physician-patient relationship,
- a breach of that duty (ie, deviation from the accepted standard of care),
- a link between that breach of duty and
- a specific harm.
MR. NEWMAN:In this case I believe the standards of care have been met. There is no legal case here.
MR. WEITZ: I agree. The complications that occurred did not result from deviation from the standard of care, but from the patient’s reaction to the procedure.
Should a law firm decide to proceed with this case, which seems doubtful, it would be hard to show any damage the patient suffered as a result of any alleged improper conduct.
Case 2: later finding of bowel injury
“Cathy” is a 40-year-old mother of 2 who is found to have a 10-mm polyp as part of her evaluation for abnormal uterine bleeding. She is scheduled to undergo hysteroscopic removal of the polyp with endometrial ablation. However, her uterus is severely retroverted, making serial cervical dilation necessary for entry. During the surgery, a pressure of 90 mm Hg is required for optimum visualization. The polyp is easily removed with a grasping instrument, and endometrial ablation is performed with a monopolar rollerball using 2.7% sorbitol for distention. Cathy is discharged the same day without complications.
Two days after the surgery, she calls with complaints of nausea, vomiting, and abdominal distention. She is told to go to the emergency room, where upright abdominal radiography shows free air in the abdomen. Cathy undergoes an exploratory laparotomy for small bowel perforation with end-to-end anastomosis and is discharged 1 week later without sequelae.
Factors that raise risk of perforation
DR. WILLIAMS: Uterine perforation is the most common complication of operative hysteroscopy. It is especially likely with cervical stenosis or severe anteflexion or retroflexion of the uterus; with lower-segment myomas or intrauterine synechiae; and when the operator is inexperienced.3-5
When perforation occurs without an electrical source, hysteroscopy usually is discontinued because of the inability to achieve uterine distention.
Terminate the procedure even if the perforation is small and distention is possible, since fluid will be lost into the peritoneal cavity. Usually, the patient can be observed and discharged home if there is no vaginal or intraperitoneal bleeding.3,4
When perforation occurs during use of electrical energy, laparoscopy is advised to rule out bowel injury.
Patients with unrecognized bowel injury after hysteroscopy frequently are not symptomatic until 2 to 10 days after the procedure due to the thermal nature of the injury, as this case illustrates.
Value of a photographic record
In this case, unrecognized perforation with later bowel injury could raise questions about adequate visualization throughout the case. Use of video or photography may be helpful to document that visualization.