Published: January 21, 2006 10:42 pm            

Surgeons soon will be required to report serious complications, deaths related to obesity procedures

As the number of weight-loss surgeries have skyrocketed in the state, Indiana surgeons soon will be required to report any serious complications or deaths related to surgery for morbid obesity.

The new reporting rules, specifics of which will be the subject of a hearing this week in Indianapolis, are a step toward gathering data about popular weight-loss procedures, said Sen. Patricia Miller, R-Indianapolis.

“We don’t have any statistical information regarding long-range outcomes for bariatric surgery,” Miller said.

Last year, the Indianapolis senator sponsored the reporting requirements as part of an amendment to an earlier related bill.

Among the provisions: surgeons monitor patients of gastric bypass surgery for at least five years and report any deaths or serious complications to the Indiana Department of Health. Physicians who fail to do so can be subject to disciplinary sanctions ranging from probation to permanent license revocation.

Bariatric operations usually are a last resort for morbidly obese patients unable to lose weight by conventional means. During stomach stapling, surgeons form a pouch out of the stomach, shrinking it from the size of a football to about the size of an egg. The surgery also bypasses part of the small intestine, reducing nutrient absorption.

Risks include infections, bleeding, blood clots, gallstones, digestive problems, vitamin and mineral deficiencies, hernias and death.

Miller believes the state data is important for determining long-range consequences of the operations. However, some surgeons say the monitoring and reporting requirements are unnecessary, punitive, even discriminatory.

One of the biggest concerns, said Dr. Neil Hutcher, a Richmond, Va., bariatric surgeon, is that Indiana surgeons will avoid high-risk procedures if their names are publicized when a patient dies. The risk is inherently higher the more obese a patient, he said.

“The doctors won’t undertake the most needy of all patients,” said Hutcher, president of the American Society for Bariatric Surgery. He said he has consulted with some bariatric surgeons from Indiana who are concerned about the proposed reporting rules.

“This is punitive. This isn’t educating the public,” Hutcher said.

Miller has addressed that concern, introducing a bill this session that would make the information reported to state health officials confidential. Under the proposed law, the public’s access would be limited to statistical reports compiled by the Department of Health. Miller introduced the bill after two surgeons expressed concerns to her about potentially negative affects on patient access.

Under the act passed last year, surgeons will have to notify the state about the gender of a patient who experiences a serious complication or dies as a result of bariatric surgery, provide the surgeon’s name, the location of the surgery and details about the death or complication.

Other information — including the patient’s race, county of residence, body mass index before surgery, any related diagnoses and cause of death when applicable — is under consideration by the state Department of Health.

Those details could be helpful to make valid comparisons and determine whether trends exist related to such operations, said Joe Hunt, assistant commissioner for public health surveillance and preparedness.

The Indiana State Department of Health will conduct a hearing Tuesday in Indianapolis about the reporting measures. The rules are expected to be effective midyear after a review process by three state agencies, Hunt said.

A study published in October in the Journal of the American Medical Association found that 2 percent of Medicare patients died within 30 days of their bariatric operations and 4.6 percent died within a year. Medicare patients who were 65 and older had a substantially higher risk of death, the results showed.

Another study published in the same journal showed that about 8 percent of patients in California who had gastric bypass surgeries from 1995 to 2004 were hospitalized before the operations, compared with 20 percent a year later. Admissions prior to surgery generally were for obesity-related problems, while hospitalizations afterward were the result of surgery complications.

Other studies have suggested the benefits of gastric bypasses outweigh the risks — something Hutcher cites as support for the procedures.

A study at McGill University Health Centre in Montreal found that patients who had bariatric surgery between 1986 and 2002 had significant decreases in death as well as the development of new health-related conditions.

“We cure 76.7 percent of all type-2 diabetics who go through bariatric surgery,” Hutcher said, another 10 percent are improved, he said, and 90 percent of people with sleep apnea who undergo weight-loss operations are cured.

Hutcher, who has performed bariatric surgery for 30 years, views the new Indiana requirements as an example of how obesity is the “last remaining socially acceptable prejudice.”

He emphasized that surgeons performing other, more risky, surgeries — such as procedures for colon cancer, which he says have five or six times the mortality rate of bariatric operations — don’t have as stringent requirements.

“Isn’t this a little bit of discrimination?” he asked.

Hutcher’s other concerns include the ability of surgeons to track patients for five years. His office asks clients to sign a contract that they will follow up with Hutcher as long as they are in the area. However, enforcing that is impossible, especially when patients relocate, he said.

“You would need a full-time detective staff, and I don’t mean that facetiously,” he said.

Miller, the Indianapolis senator, believes five years is a reasonable period of time, because some complications may not arise right away. Usually, people are satisfied with bariatric surgery after a year, she said.

Miller sponsored the reporting amendment after noticing a plethora of television ads for bariatric surgery and hearing from a few constituents about side effects of the procedures.

The patients, who experienced calcium and iron deficiencies, felt as if they were not provided enough information about possible complications before the procedures. One constituent required iron infusions to treat the deficiency, Miller said.

Karin Grunden can be reached at (812) 231-4257 or karin.grunden@tribstar.com.

If you go

What: Public hearing on proposed rules for reporting deaths and serious complications related to bariatric surgery.

When: 2 p.m. Tuesday.

Where: Rice Auditorium at the Indiana Department of Health, 2 N. Meridian St., Indianapolis.

What happens next: Presenters’ comments will be reviewed by the state Department of Health executive board. The state budget agency will consider the fiscal impact of the new rules before the Attorney General’s office reviews them. It will be midyear before the rules can be implemented.

Source: Indiana State Department of Health

Gastric bypass fast facts

Gastric bypass surgeries reduce the size of the stomach and alter the flow from stomach to intestine, leading to poor absorption of calories, vitamins and minerals.

Who is it for?

Not everyone. According to the National Institutes of Health, the surgery is an option for those who are significantly obese and have tried unsuccessfully to lose weight through non-surgical methods. It also can be recommended for obese patients who have sleep apnea, type-2 diabetes and heart disease.

What are the risks?

Infections, blood clots, gallstones, digestive problems, vitamin and mineral deficiencies, hernias and death.

Where is it done?

Indianapolis, Carmel, Franklin, Evansville and Urbana, Ill. Currently, the procedures are not done in Terre Haute.

How much does it cost?

About $25,000.

Sources: National Institutes of Health, American Society for Bariatric Surgery, Associated Press

By the numbers

Bariatric surgeries performed in Indiana:

Year Number

1995 332

1996 297

1997 396

1998 445

1999 585

2000 911

2001 1,146

2002 1,609

2003 2,540

Source: Indiana State Department of Health

        

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