Reviews About Dr Richard Berger Knee Replacement Surgery Chicago
Surgeon vs. Genu Maker: Who'southward Rejecting Whom?
CHICAGO
IT was a long, fruitful medical marriage that is fast becoming an angry public divorce, one that offers a rare look at a clash betwixt a top-shelf consultant and his corporate patron over patient safety.
For years, Dr. Richard A. Berger designed surgical tools and artificial joints for Zimmer Holdings, trained hundreds of doctors to employ its products and talked it upwards wherever he went. In return, Zimmer, an orthopedic implant maker, helped enrich Dr. Berger, portraying him as a primary surgeon and paying him more than $8 million over a decade.
Those days are gone. Dr. Berger started complaining to Zimmer a while back that one of its artificial-genu models was failing prematurely, and he went public recently with a report that he says proves it. Zimmer told him that the problem was non the artificial knee, but his technique, and pointed to data overseas indicating that the knee was safe.
Last year, Zimmer did not give Dr. Berger a new contract. The company says it routinely rotates consultants.
"I trained hundreds of doctors for them and made them tens of millions," Dr. Berger said in interview here, in which he also lambasted Zimmer executives equally dissembling, out-of-touch bureaucrats. "And then was this just a coincidence? Maybe it was. Peradventure it wasn't."
Zimmer executives declined to exist interviewed. The visitor said in a statement that information technology had thoroughly investigated Dr. Berger's complaints in 2006 and that he had disagreed with its findings.
Amid the booming use of artificial joints in the United States, the breakup between Dr. Berger and Zimmer highlights what experts say is a troubling situation for patients and doctors: when disputes ascend well-nigh orthopedic implant safety, there are no contained referees or sources of information because no one tracks the performance of the devices.
"There is no way of knowing who is right because we don't have the data," said Dr. Kevin J. Bozic, a professor of orthopedic surgery at the Academy of California, San Francisco.
While producers of implanted heart devices have a voluntary system in which outside panels investigate problems, American makers of orthopedic devices practise not. Many of the bogus joints that surgeons like Dr. Berger use, including the Zimmer knee at issue, are cleared under police by the Food and Drug Administration for sale without testing in patients. In addition, no i in the land tracks the long-term operation of artificial hips and knees, a $6.seven billion annual business that surged every bit baby boomers reached middle age.
THOSE with the most to lose are the hundreds of thousands of people who receive an orthopedic device each year.
One patient, Lisé Markham, said she underwent surgery recently to supercede a flawed hip just two years after getting it. She said the feel awakened her to how footling patients can observe out about an implant'south track record.
"My dr. knew everything about me, every personal detail, but what did I know on the other side?" said Ms. Markham, who lives in San Diego.
Two years agone, another acme Zimmer consultant, Dr. Lawrence Dorr of Los Angeles, alerted surgeons that a company hip model was failing later on a few years. Zimmer shot back, saying the problem was Dr. Dorr's technique, non the device. Forth with briefly halting sales, information technology also provided the F.D.A. with information from 12 surgical centers showing that the hip was working well. Based on that, the agency decided to close its investigation, said an F.D.A. spokeswoman, Mary Long.
But in interviews, 2 doctors who provided Zimmer with supportive information in 2008 said the hip started failing soon afterward in their patients, too. One, Dr. Richard Illgen of the University of Wisconsin, said he now realizes that Dr. Dorr's technique was not the issue, just that Dr. Dorr had but started using the Zimmer hip before other surgeons. Zimmer all the same defends the product, which is known every bit the Durom hip.
These days, companies similar Zimmer have fewer consultants, part of the fallout from settlements in 2007 past several companies, including Zimmer, of Justice Department charges that consultant payments were used to disguise kickbacks to surgeons. Notwithstanding, relationships with Dr. Berger and Dr. Dorr were non called into question.
Nearly a decade ago, when the relationship between Dr. Berger and Zimmer began, it was filled with promise. The surgeon, a tall, balding man with a boyish manner, was finishing his fellowship at the Rush Academy Medical Center in Chicago at the time, 1 of the country'southward peak centers for joint replacement. The eye has had long ties to Zimmer, whose headquarters is about two hours away, in Warsaw, Ind., and the young surgeon quickly came to the company'southward attention.
"Rich has a very clever set of hands, and because of that he is enabled with the ability to innovate surgical techniques," said Roy Crowninshield, who was Zimmer's chief scientific officer.
Dr. Berger'southward skills matched Zimmer'south marketing strategy. To distinguish itself from competitors, the device maker had started promoting minimally invasive surgery, a technique that uses smaller incisions than traditional surgery. Zimmer trained doctors in the procedure, using its device.
Before long, Dr. Berger, who was then pioneering a type of small-scale-incision surgery that immune patients to exit the hospital on the day of surgery, became a linchpin of Zimmer's efforts. In 2002, he was prominently featured in a printing release about Zimmer's plans to build a preparation facility for minimally invasive surgery.
"We are clearly excited most Dr. Berger'due south information," J. Raymond Elliott, the company'south chairman and chief executive at the time, stated in the release.
Over the side by side few years, the medico estimates, he helped train hundreds of surgeons on Zimmer's behalf. His star also rose: he and his technique were featured on "World News This night" on ABC, and he was soon performing nearly one,000 hip and knee joint replacements annually, almost all with Zimmer devices.
But Dr. Berger, who is 47, with free energy and cocky-confidence to spare, also became a lightning rod. Other doctors questioned whether his technique of using such a modest incision could be broadly adopted, and interest in his arroyo brutal. The concern was that such a tiny opening left doctors with lilliputian room for error.
Dr. Berger brushes off complaints, proverb that many surgeons exercise not accept the skill or the patience to learn his technique. "There are lots of reasons that people don't desire to do something new," he said.
As he tells information technology, his relationship with Zimmer frayed over a version of a widely used Zimmer genu, known equally the NexGen. The model at issue, called the NexGen CR-Flex, is designed to provide a greater range of move than the standard NexGen.
Virtually surgeons implant an bogus knee using a cement-like adhesive to bond the thigh bone to the portion of the device that bends. But some specialists, similar Dr. Berger, try to avoid adhesives because the cement can interruption down and cause device failure. So Zimmer also sells an uncemented version of the CR-Flex that relies instead on the bone naturally fusing with the implant.
Dr. Berger says that he gave the device, which is supposed to last near 15 years, to about 125 patients in 2005, the showtime full year he used it. But by early 2006, some X-rays showed lines where the implant met the thigh os, an indication that the device was loose and had non fused completely. Patients could walk, but they were reporting pain, plain a result of the loose joint.
He says he shortly brought the trouble to the attention of Zimmer officials, including the company's new top scientist, Cheryl R. Blanchard. Zimmer executives pointed to the success of the NexGen, just the company did non accept separate examination data on the uncemented flexible model because the F.D.A. had not required the company to study it in patients before selling it.
Later, as more patients complained about the device and Dr. Berger had to supervene upon some of them, he spoke to Ms. Blanchard again, he said. This time, he said, she and other Zimmer officials suggested that his technique was the problem because no other surgeon had complained.
"Suddenly, I went from someone who was their master instructor to someone who didn't know what he was doing," he said.
By 2007, Dr. Berger, although still a Zimmer consultant, had stopped using the device and had learned, he said, that several other surgeons had also experienced bug with it. But different Dr. Dorr, the physician who sent out the alert about Zimmer, Dr. Berger said he initially had hoped to avoid a public showdown with the visitor. So he followed a more traditional route past performing a study with another Rush surgeon, Dr. Craig J. Della Valle, who was likewise having to replace the Zimmer genu.
Dr. Berger and Dr. Della Valle beginning presented their study at a medical meeting last autumn and over again this yr at a national meeting of the American Association of Orthopedic Surgeons. They found that the uncemented Zimmer knee joint failed early in well-nigh 9 percent of some 100 patients studied. Also, the articulatio genus exhibited signs of looseness in about one-half of all patients and has since been replaced in some of them, Dr. Berger said.
But Zimmer was unswayed. In a filing with the Securities and Exchange Committee, Zimmer made notation of the study simply besides pointed to the genu's very positive results in a large database of orthopedic patients in Commonwealth of australia. Officials there confirmed the low failure rate. The company besides said that the cement-costless CR Flex deemed for but a modest fraction — about 2 per centum — of its overall knee sales.
Zimmer said that collaboration with surgeons like Dr. Berger was critical to the success of its products. "To date, Dr. Berger remains a valued customer of Zimmer," the company stated.
That may also change before long. Dr. Berger said he was talking with another device maker well-nigh consulting and is trying out other products.
Every bit for Zimmer, he said, "I have lost confidence."
Source: https://www.nytimes.com/2010/06/20/business/20knee.html
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