Lap-Band law is a victory for family

FDA Adverse Event Information, Medical Device Approval Process, and FDA Corruption

Lap-Band law is a victory for family

PostPosted by hopeful19 » Sun Jan 08, 2012 10:05 pm

By Nick Green Staff Writer

There was no Christmas tree in the home of Betty Brown during the holiday season. And her family didn't gather as usual to celebrate.

A year earlier, on the day after Christmas in 2010, they had taken Brown's 52-year-old sister, Tamara Walter, off life support. That decision came just three days after she had undergone Lap-Band surgery in a desperate attempt to shed weight.

So on this past Christmas Day, Brown instead went to see the escapist comedy "We Bought a Zoo" with her granddaughter.

"We wanted to be alone," Brown said. "This was probably the toughest holiday I ever had. ... Christmas will never be the same."

Yet Brown faces the new year with a degree of satisfaction.

A state Senate bill that provides greater oversight of the medical facilities that carry out many of the procedures became law on Jan. 1.

"I felt that if we could get this bill passed it would help regulate and monitor the different surgery centers," Brown said. "I feel if some of these regulations were in place, my sister wouldn't have died. We're trying to educate the public. People don't realize the seriousness of this type of surgery."

Brown is convinced her sister did not.

Brown was 17 years older than her sister, a Lawndale resident.

Because of the age gap between the two, Walter was more like a daughter than a sister to Brown in the family of four siblings, who were born and raised in Torrance.

Walter was a petite woman, standing just 5-foot-1. Active as a youngster, she enjoyed jet skiing and horseback riding.
But in the last decade of her life she struggled with her weight and became unhappy. Walter's obesity brought on high blood pressure, sleep apnea and joint pain.

At the time of her death, she weighed 225 pounds, according to the county coroner's autopsy report. With a body mass index of 41, Walter was classified as "extremely obese."

But in December 2010, Walter was in high spirits.

A manager at a local grocery store, Walter had just bought a new house and had a new grandchild.

The Food and Drug Administration has approved of Lap-Band surgery for most patients with a BMI of 30 to 40 and at least one weight-related medical condition such as diabetes.

The procedure involves inserting an inflatable silicon ring at the top of the stomach to make the patient feel full. It is considered the lowest risk procedure among several different types of surgery to induce weight loss.

Yet complications, ranging from infection to death, are possible.

Five Southern Californians, including Walter, have died since 2009. Four of those deaths, including that of Walter, have resulted in lawsuits against the companies and medical professionals that marketed and performed the procedures.

Still, as Californians grow more obese, the number of such procedures is rising.

After hearing advertisements from a marketing firm called 1-800-GET-THIN, Walter decided to join the ranks of state residents undergoing the surgery.

The outpatient surgery occurred Dec. 23 at what was then called the Beverly Hills Surgery Center in the 9000 block of South Wilshire Boulevard.

But after the surgery, she began having respiratory problems, which led to cardiac arrest. Transferred to Cedars-Sinai Medical Center, Walter never regained consciousness.

A subsequent autopsy report found that Walter's anesthesiologist provided "suboptimal management" of her sleep apnea and pressure from swollen lungs. The report also found fault with the "possible inadequate reversal of muscle relaxants."

In September, Walter's three siblings filed a lawsuit in Los Angeles Superior Court.

It alleges the defendants in the case, including 1-800-GET-THIN and the surgical centers involved in the procedure, had represented the "state of the art" surgical centers possessed "an unmatched safety record."

In fact, at the time the surgeon who operated on Walter was under investigation by the California Medical Board, the suit charges. And the board had placed the anesthesiologist involved in the surgery on probation, after he was convicted in 2006 of assaulting a process server with a deadly weapon - a meat cleaver - in Torrance.

"Moreover, these defendants also knew that the surgery center had a history of documented deficiencies and its accreditation been refused or revoked by more than one accrediting agency," the lawsuit alleged. "These defendants were motivated to conceal these deficiencies and the increased risk of significant harm to Tamara Walter attendant to these deficiencies, by the financial benefit they would receive when the physicians they hired performed the Lap-Band surgery."

Pasadena attorney Robert B. Silverman, president of 1-800-GET-THIN, has called the allegations in the lawsuit "baseless and false."

The lawsuit is ongoing.

Meanwhile, the deaths of patients at surgical centers, including that in 2007 of the mother of musician Kanye West, had caught the attention of state Sen. Curren Price, D-Los Angeles.

He co-authored Senate Bill 100, the bill that provided greater oversight and strengthened the regulation of surgical and fertility clinics.

For instance, before the passage of the bill, a quirk in the law resulting from a court case meant the state medical board could only take action against a physician's license and could not close down a particular clinic if problems existed.

"This is absurd," Price said in a June 2011 press release. "We have got to find a way to shut down clinics when serious problems exist."

Brown agreed.

So in July, she testified before the Senate Business, Professions and Economic Development Committee in an effort to honor her sister's memory and make some sense of her death.

Specifically, she wanted to emphasize that what was represented to her sister as a relatively easy cosmetic procedure actually amounted to surgery under general anesthetic.

"You could have heard a pin drop," said Brown's Beverly Hills attorney, Kathryn Tripinski, "The legislators were absolutely riveted. ... Afterward, the staffers gave Betty and me hugs. I felt it was a very meaningful and profound event."

And effective.

The committee approved the bill unanimously.

"I was shocked and dismayed by the testimony given at the hearings by family members who lost their loved ones in some of these surgical centers," said Price, who chairs the committee. "Each new report of a senseless and unnecessary death only further demonstrates how important this bill is.

"While the death of Kanye West's mother brought this issue to the attention of the wider public, the heartfelt testimony of Betty Brown on the loss of her sister further struck at the heart of the issue and reinforced my determination to push for this legislation that greatly increases oversight of these centers.

"We will also work to see that the agencies move swiftly to discipline those violators and prevent them from doing further harm."

Brown said she was "surprised and "thrilled" when Price's bill made it to the governor's desk and he signed it.

Silverman said he, too, had urged the governor to sign the legislation.

"We're pretty much in favor of SB 100," he said. "After doing surveys of (medical) facilities we do business with, it appears the facilities are SB 100 compliant."

Brown hopes the legislation, while too late for her sister, will help save the lives of others.

"No family should go through this, no family should lose a loved one," Brown said. "She can't have died for no reason. Something good had to come out of this."
"There's almost no risk involved," says Stephen Fanning, CEO of Solta Medical, which owns Fraxel.

The world is a dangerous place to live, not because of the people who do evil, but rather those who sit back & let it happen.
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