Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Saturday, September 28, 2013

Stents overused: criminal medical treatment?



By Peter Waldman, David Armstrong & Sydney P. Freedberg - Sep 25, 2013 9:01 PM PT
FiDA highlight

Then he went to see cardiologist Samuel DeMaio for chest pain. DeMaio put 21 coronary stents in Peterson’s chest over eight months, and in one procedure tore a blood vessel and placed five of the metal-mesh tubes in a single artery, the Texas Medical Board staff said in a complaint. Unneeded stents weakened Peterson’s heart and exposed him to complications including clots, blockages “and ultimately his death,” the complaint said.
DeMaio paid $10,000 and agreed to two years’ oversight to settle the complaint over Peterson and other patients in 2011. He said his treatment didn’t contribute to Peterson’s death.
“We’ve learned a lot since Bruce died,” Shirlee Peterson said. “Too many stents can kill you.”
Peterson’s case is part of the expanding impact of U.S. medicine’s binge on cardiac stents -- implants used to prop open the arteries of 7 million Americans in the last decade at a cost of more than $110 billion.
When stents are used to restore blood flow in heart attack patients, few dispute they are beneficial. These and other acute cases account for about half of the 700,000 stent procedures in the U.S. annually.
Among the other half -- elective-surgery patients in stable condition -- overuse, death, injury and fraud have accompanied the devices’ use as a go-to treatment, according to thousands of pages of court documents and regulatory filings, interviews with 37 cardiologists and 33 heart patients or their survivors, and more than a dozen medical studies.
’Marching On’
These sources point to stent practices that underscore the waste and patient vulnerability in a U.S. health care system that rewards doctors based on volume of procedures rather than quality of care. Cardiologists get paid less than $250 to talk to patients about stents’ risks and alternative measures, and an average of four times that fee for putting in a stent.
“Stenting belongs to one of the bleakest chapters in the history of Western medicine,” said Nortin Hadler, a professor of medicine at the University of North Carolina at Chapel Hill. Cardiologists “are marching on” because “the interventional cardiology industry has a cash flow comparable to the GDP of many countries” and doesn’t want to lose it, he said.
Stenting abuse is by no means the norm, but neither is it a rarity. Federal cases have extended from regional medical centers in Louisiana, Kentucky and Georgia to a top-ranked metropolitan hospital system in Ohio.
Asset Seizure
A doctor practicing at a hospital owned by the Cleveland Clinic, rated the premier heart center in the country by U.S. News and World Report, had his assets seized by federal agents in a stent investigation, according to federal court filings in April. The Clinic has not been accused of wrongdoing, and says it’s cooperating with the investigation.
Two out of three elective stents, or more than 200,000 procedures a year, are unnecessary, according to David Brown, a cardiologist at Stony Brook University School of Medicine in New York. That works out to about a third of all stents.
Brown said his estimate is based on eight clinical trials of 7,000 patients in the last decade, which he analyzed in the Archives of Internal Medicine last year. Two cardiology researchers who have studied the use of stents say the number could be as low as about half Brown’s estimate, and one said it is probably larger.
Costs, Risks
Even the low end of these estimates translates into more than a million Americans in the past decade with implants in their coronary arteries they didn’t need, said William Boden, chief of medicine at a Veterans Administration hospital in Albany, New York. Boden was the principal investigator of a 2007 study known as Courage that found stents added no benefit over medicines, exercise and dietary changes in stable patients.
Unnecessary stents cost the U.S. health care system $2.4 billion a year, according to Sanjay Kaul, a cardiologist and researcher at Cedars-Sinai Medical Center in Los Angeles. Patients who received them are living with risks including blood clots, bleeding from anti-clotting medicine and blockages from coronary scar tissue, any of which can be fatal, Kaul said.
Monica Crabtree died at age 64 after one of her arteries was torn in a stent procedure that led to infection, according to her widower, Gary Crabtree. He received at least $240,000 from a 2011 settlement of his lawsuit against her doctor, after a second cardiologist reviewed the case and told him the stent wasn’t needed. Crabtree choked up speaking about his late wife and showed pictures of their 47 years together.
Worried Shaving
“It wasn’t just a simple mistake,” said the retired auto worker in Largo, Florida. “If the stent was something she really needed, I could have handled it. But it was a total loss of life that didn’t need to happen.”
Jim Simecek, of Medina, Ohio, said he worries every morning that a nick from shaving could bleed out of control. Simecek, who works at a Ford dealership, said he has to take blood-thinning medicine for life to ward off clots in the six stents he received from a Cleveland-area cardiologist who’s under federal investigation for his stent work.
“It’s as if your heart was open and somebody was sticking a knife in,” said Rhonda McClure, 54, referring to eight stents she received from a Kentucky cardiologist who agreed in June to plead guilty to a federal Medicaid-fraud charge for falsifying records used to justify a stent he placed.
Patient Letters
Cardiac stents were linked to at least 773 deaths in incident reports to the U.S. Food and Drug Administration last year, according to a review by Bloomberg News. That was 71 percent higher than the number found in the FDA’s public files for 2008. The 4,135 non-fatal stent injuries reported to the FDA last year -- including perforated arteries, blood clots and other incidents -- were 33 percent higher than 2008 levels.
The FDA declined to comment on whether the reports were a cause for concern. It said adverse-event reports tied to medical devices have increased overall due to agency efforts. It also said the data can contain incomplete and unverified accounts from reporting parties.
More than 1,500 patients have gotten letters from hospitals since 2010 alerting them that their stents may have been unnecessary. In Philadelphia, the University of Pennsylvania Health System sent 700 such notices in April.
Stenting Decline
At least 11 hospitals have settled federal allegations of charging for needless stenting and other misdeeds in the catheterization labs where the procedures are performed. Federal probes of stenting practices continue in at least five states. In Louisiana and Maryland, cardiologists went to federal prison last year for implanting the devices and charging for them without medical justification. A third doctor has agreed to do time in a plea bargain.
“There is a huge financial incentive to increase the number of these procedures,” said Jamie Bennett, a former assistant U.S. Attorney in Baltimore who handled stent investigations. “The cases we have seen to date are just the tip of the iceberg.”
Since Boden’s Courage study, stenting procedures have declined by about 20 percent. Still, this July, a panel of experts convened by the American Medical Association and the Joint Commission, a hospital accreditor, named elective stenting as one of five overused treatments that too often “provide zero or negligible benefit to patients, potentially exposing them to the risk of harm.”
Better Choices
Doctors are using fewer stents and choosing more-appropriate patients than they were a few years ago, according to John Harold, president of the American College of Cardiology, the specialty’s main professional group. Harold said that “real-world clinical practice” and research indicates Brown probably overestimated how many people with coronary artery disease could be handled initially only with drug-based treatment.
He said there are examples of inappropriate use and the ACC is taking steps to “address and correct the imbalance” with treatment guidelines and by urging more hospital oversight. Cardiologists who’ve been accused of fraud or are serving prison time are “outliers” who don’t represent the “overwhelming majority.”
Lawyers for John McLean, a Salisbury, Maryland, cardiologist convicted of billing for unwarranted stenting, argued in a federal appeal last year that inappropriate usage is widespread and their client was prosecuted for behavior that’s the industry norm.
Lost Appeal
They cited a 2011 study in the Journal of the American Medical Association that found only half of elective stent procedures nationally were appropriate under usage guidelines written by societies of heart specialists. The study found 12 percent were inappropriate, and 38 percent fell into the uncertain category of the guidelines.
“The study demonstrated clearly that a large number of stable patients receive coronary artery stents that are later found to be inappropriate or questionable,” the appeal argued. “The same was true of the patients in Dr. McLean’s practice.” McLean’s appeal was denied in April. He is serving an eight-year sentence.
Elective-stent patients typically see rapid quality-of-life improvements, including in their ability to work and be active, according to Ted Bass, president of the Society for Cardiovascular Angiography and Interventions, whose members specialize in cardiac implants. The Courage trial found stents, compared to medication and lifestyle changes, were better at relieving chest pain for as long as two years after placement -- a benefit that ended by 36 months.
Profit Centers
First used in Europe in 1986, cardiac stents took off in the 2000s as cardiologists found them to be more effective in heart attacks than angioplasty. In that earlier technology, a small balloon is inflated to widen blood passages and then withdrawn. Stenting facilities, known as “cath labs,” spread at hospitals and became profit centers.
Hospitals receive an average payment of about $25,000 per stent case from private insurers, according to Healthcare Blue Book, a website that tracks reimbursements. The federal Medicare program pays less. Doctors who implant stents earn a separate fee that averages about $1,000 and ranges from $500 to $2,850, according to Medicare and Blue Book data.
The procedure typically involves inserting the stent with a catheter through a small incision in the groin area or wrist and snaking it through to heart vessels. It usually takes less than 45 minutes.
Kickbacks Alleged
Stony Brook’s Brown, and Boden, who led the Courage study, argue that many elective patients should be getting medical therapy before they risk stents. Only 44 percent try medication and lifestyle changes before stenting, a 2011 study in the Journal of the American Medical Association found.
At least five hospitals have reached settlements with the Justice Department over allegations that they paid illegal kickbacks to doctors for patient referrals to their cath labs. St. Joseph Medical Center in Towson, Maryland, paid the government $22 million without admitting liability.
Prosecutors alleged the hospital paid kickbacks to a practice co-founded by Baltimore cardiologist Mark Midei for stent referrals. His doctor’s license was revoked in 2011 when the Maryland Board of Physicians found he falsified records to justify unwarranted stents.
St. Joseph told 585 of its patients they may have received unnecessary stents. In May, 252 patients reached a settlement with the hospital under confidential terms, according to Jay D. Miller, an attorney for the plaintiffs.
Plea Agreement
The hospital settled the government’s case “to avoid the expense and uncertainty of litigation,” it said in a statement. Spokeswoman Julia Sutherland said the hospital declined to comment on any patient lawsuits.
In an interview, Midei denied he stented without medical need. He took issue with experts who deemed many of his stents needless, and said disagreement among cardiologists on cases is common. Midei was not a party to the federal settlement. The government has said its investigation of the case continues.
In June, Sandesh Patil, a cardiologist practicing at another St. Joseph hospital -- this one in London, Kentucky -- agreed to plead guilty to charging Medicaid for a stent that wasn’t medically warranted under the program’s rules. (Although both hospitals were once owned by the same parent, the one in Maryland has been sold.)
Catheterization procedures multiplied at St. Joseph in London after Patil began practicing there in 2000, when the hospital had a different name. In that year, the type of procedure used for stents was done 210 times. They climbed to 929 by 2009, state data show.
Multiple Stents
Stenting income from Medicare alone was more than a sixth of the hospital’s 2009 operating income, based on data from American Hospital Directory, a research firm. When Patil left London in 2010, catheterization procedures fell 34 percent from their 2009 high. Using the midpoint of the directory’s price range for such procedures, the decline would have cost the hospital about $15 million. David McArthur, the hospital’s spokesman, declined to comment on its revenues.
Rhonda McClure, one of Patil’s patients, had her arteries catheterized 18 times by him and his partners over four years, according to her deposition and other filings in a lawsuit she and 361 other patients have brought against Patil, St. Joseph and other doctors who practiced there. She said she received eight cardiac stents. The defendants deny the negligence and fraud allegations against them.
McClure’s deposition says a cardiologist who reviewed her case after the stents told her that scarring caused by “too many procedures” was her main problem.
Short Breath
McClure said she suffers from chest pain and shortness of breath, and has been told by her new doctor that she may need more stents and surgery to keep her coronary arteries from closing. She said she gets so tired she needs to sit and rest after walking down the stairs.
St. Joseph-London repaid Medicare $256,800 for unnecessary procedures and is cooperating with federal prosecutors, McArthur said. He said Patil was never employed by St. Joseph and lost his privileges to practice there in December 2010. Patil’s attorney said his client had no comment.
Under his plea bargain, Patil agreed to serve 30 to 37 months in federal prison. He forfeited his Kentucky medical license for five years. In 2012, he told a family court judge his monthly income was $53,300.
“Thirty-seven months is nothing for all the injuries he done for money,” McClure said.
Message Balancing
After the Courage trial shed doubt on stents’ effectiveness for stable patients, stent-implanting cardiologists felt unfairly attacked and organized a campaign to “better balance the messaging,” said Bonnie Weiner, who was president of the Society for Cardiovascular Angiography and Interventions at the time.
The society hired a public relations firm and paid it more than $300,000 a year to help publicize the benefits of stents, according to the group’s filings with the Internal Revenue Service. The firm helped launch a consumer website for SCAI, SecondsCount.org, which has published several articles, including one under the headline, “For many patients, open arteries are better than closed arteries.”
SCAI collected $2.7 million in donations for “public education” between 2008 and 2011 from stent makers Abbott Laboratories (ABT) Inc., Boston Scientific Corp. (BSX), Cordis Corp. and Medtronic Inc. (MDT), its Web site says. Manufacturers’ sales of cardiac stents were about $5.5 billion globally last year, down 5 percent from 2011, according to the Health Research International consulting firm.
High Median
Medtronic spokesman Joseph McGrath said grants to SCAI for patient education are “unrestricted,” and SCAI is solely responsible for how the funds are used. Spokesmen for Abbott, Boston Scientific and Cordis declined to comment.
Interventional cardiologists, the specialty SCAI represents, earn a median income of $562,855 a year, as compared to $207,117 for family doctors, according to Medical Group Management Association, which surveys physician practices. The interventionalists ranked 13th among 118 specialties tracked by MGMA.
Michigan Death
Mehmood Patel, a Lafayette, Louisiana, cardiologist who went to prison last year on 51 counts of charging for needless stents, made over $16 million in one three-year span, evidence in the case showed. Prosecutors said he was driven by the desire to be the busiest cardiologist in town.
He unsuccessfully argued that he used his best medical judgment in every case and lost an appeal. Patel is serving a 10-year sentence in a federal penitentiary.
Jashu Patel, an interventionalist in Jackson, Michigan, billed $2.7 million for procedures in 2007, according to a U.S. Justice Department case against him settled in July. (He is no relation to Mehmood Patel).
The suit alleged Patel implanted needless stents in at least two patients, including one that led to a blood clot that killed an unnamed woman who had reported no symptoms of reduced cardiac blood supply. A stress test showed normal blood flow, and notes in her file said she didn’t want interventions, said Julie Kovach, a cardiologist who worked with Patel and brought the case to the government’s attention.
“It was appalling,” Kovach said in an interview. “Patel coerced her into getting a stent she didn’t need, which killed her.”
False Claims
Kovach said that when she told the chief operating officer of the hospital where Patel worked about the death, the executive, Karen Chaprnka, diverted the conversation. Reached recently by e-mail through a hospital spokesman, Chaprnka said she “disagreed with the allegations made by Dr. Kovach.”
“He’s their cash cow,” said Kovach, now co-director of a clinic that treats congenital heart disease at the Detroit Medical Center. “They’re not about to turn him in.”
Patel and the hospital, Allegiance Health, agreed to pay the U.S. a total of $4 million to settle the federal charges. Kovach was awarded $760,000 as a whistle-blower under the U.S. False Claims Act. Allegiance disagreed with the allegations and settled the claims to avoid “lengthy litigation,” it said in a statement.
Patel continues to practice at the hospital and must improve record-keeping to substantiate cardiology procedures, Allegiance said. In the settlement, Patel agreed to hire a consultant to oversee treatment of his patients and an auditing firm to monitor billings. He didn’t return phone messages.
Cleveland Raid
In Ohio, Simecek, the worker at the Ford dealership, grew suspicious after his sixth stent from cardiologist Harry Persaud at the Cleveland Clinic’s Fairview Hospital in 2011. Simecek said he went for a second opinion and was told he didn’t need any of the stents. Now he said he has to take blood thinners the rest of his life.
“With the littlest cut, the blood starts running,” said Simecek. “What if I am in an auto accident?”
Persaud is under criminal investigation for health care fraud, mail fraud and money laundering, according to federal court filings. Last October, Federal Bureau of Investigation agents raided his office and removed financial records and patient files for procedures at three Cleveland-area hospitals. The government has seized $343,634 from his and his wife’s bank accounts, alleging the funds represent the proceeds of fraud related to a “significant number” of unnecessary stent procedures.
Multiple, Elongated
The Cleveland Clinic found “problems related to the use of stents in some patients” at Fairview and reported them to the government, according to spokeswoman Eileen Sheil. She would not say how many patients were affected. Persaud resigned from the hospital staff last year.
At least 64 of Persaud’s patients at St. John Medical Center in suburban Westlake received letters from the hospital saying they may have received an unnecessary stent between 2010 and 2012, according to spokesman Patrick Garmone, who said Persaud no longer practices there.
Persaud denied wrongdoing in court filings and said his stent procedures were proper. Neil Freund, his attorney in lawsuits filed by patients alleging unwarranted stents, said “it is our intent to defend these cases.” He had no comment on the federal investigation.
Final Order
In Texas, the state medical board’s final order in DeMaio’s case found that the cardiologist placed “multiple, elongated, overlapping” stents in patients in areas of “insignificant or only moderate disease.” Peterson, the retired mailman, was identified only as Patient C in the staff complaint. No patient was mentioned in the final order.
Peterson was thriving in his new career in the travel business, his wife Shirlee said. He had a heart attack in 1997, which didn’t crimp his love of travel and dance, she said. “He was an awesome man who never met a stranger,” she said.
After his death, Shirlee Peterson said a friend told her she had a cardiologist who refused to do multiple stents.
I do believe that Bruce was a guinea pig,” she said. “That was the way it was done.”
DeMaio said Peterson was extremely sick when he came to him. He said it was significant that the board’s final order didn’t use the word ”excessive” in describing his stent work. That included 31 stents stretching for 14 inches inside the arteries of Patient B in the staff complaint.
“Any patient of mine who received a full metal jacket” -- interventional cardiology’s term for such extensive work -- “would have been turned down by at least one, if not multiple surgeons,” DeMaio said. He said he doesn’t use stents as much these days because standards have changed and he doesn’t see as many seriously ill patients.
To contact the reporters on this story: Peter Waldman in San Francisco at pwaldman@bloomberg.net; David Armstrong in Boston at darmstrong16@bloomberg.net; Sydney P. Freedberg in Miami at sfreedberg@bloomberg.net
To contact the editor responsible for this story: Gary Putka at gputka@bloomberg.net


Tuesday, September 24, 2013

Implant biofilm - DEADLY PREVENTABLE HOSPITAL ACQUIRED INFECTIONS

VIDEO - Most Important Meeting of the Year: HAI's Senate HELP (Health, Education, Labor and Pensions) committee
9/24/2013


How this relates to implanted medical devices:

New research on deadly biofilm that grows on some implanted medical devices:


Jane Akre reports on this in her Medical Mesh Newsdesk post:

Biofilm Protects Bacteria and Cause Chronic Infection

Sep 22nd, 2013 | By  | Category: Medical News
Biofilm cluster, UC Berkeley
Biofilm cluster, UC Berkeley
University of California, Berkley researchers hope to attack something called biofilms, which house bacterial infections protecting them from antibiotics.
New research using a super-resolution light microscopy,  reveals how bacteria forms communities and a protective coat called a biofilm. Researchers say the tenacious bacteria and its coating causes lung infections in cystic fibrosis patients, chronic sinusitis, cholera and infections around medical implants such as pacemakers, joints and stents.
Many patients with mesh implants also have constant chronic infections around the implant.
Published in the July 13th edition of the journal Science, UC Berkeley’s Department of Physics and the California Institute for Quantitative Biosciences researchers observed within six hours a single bacterium that created a cluster. The bacterium then secretes a glue-like protein that creates a protective shell.
The sensitive microscope could differentiate between the different color dyes applied strategically to observe the different stages of biofilm development, creating a 3-D movie.
One way to rid biofilm and its immune response in the sinuses is to surgically remove the tissue. When there is a sticky plaque of biofilm housing infection around an implant, the way to address the infection is to remove the device and replace it with a sterilized implant.
“Eventually we want to make these bugs homeless,” said one researcher in a news release here.
About 80 percent of human infections are related to biofilms. Researchers hope to be able to target the glue-like protein to dissolve the bacteria’s housing so antibiotics have access.
Learn More:




Friday, September 20, 2013

TX cardiac surgeon harms patients and gets wrist slap!


By DANIEL LATHROP  Fida highlight, highlight, bold
Staff Writer
Published: 18 September 2013 11:01 PM
Updated: 19 September 2013 01:43 PM

The Texas Medical Board has fined a McKinney heart doctor for implanting unnecessary stents into cardiac patients, according to records released by the board.
A medical board panel found that Dr. Taysir Jarrah had performed improper procedures in at least 10 cases at Heart Hospital Baylor Plano and that his “incompetence” was “likely to harm the public,” according to the order fining him.
Jarrah, who declined to comment, agreed to pay a state fine of $3,000 and must take eight hours of classes on record keeping and two hours of classes on medical ethics, an order approved Aug. 30 shows. His license has not been suspended.
The case came to light when a hospital employee reported concerns about Jarrah’s performance of stent procedures to managers, hospital spokeswoman Nikki Mitchell said.
An investigation at the hospital found that Jarrah performed 21 surgeries “without any documentation of the clinical basis for the procedures,” according to the state order.
The Plano hospital suspended his privileges and reported him to authorities, and the state then launched its investigation. The hospital did not confirm the date of those actions but said he hasn’t done a procedure at the hospital since October 2011.
Jarrah was a shareholder at the doctor-owned hospital but hasn’t been since April 2012, Mitchell said. He also resigned his privileges, according to the medical board order.
The stent procedure involves inserting a tube into weakened or blocked arteries to restore blood flow and prevent future heart attacks and aneurysms, according to the National Institutes of Health. It is not considered an invasive procedure.
Since the hospital’s investigation into Jarrah, it has begun conducting reviews of every proposed heart catheterization, Mitchell said.
Jarrah’s patients were invited to meet face-to-face with top hospital officials, who have had 20 such meetings, Mitchell said.
“All monies related to Dr. Jarrah’s potentially medically unnecessary procedures were immediately refunded to Medicare, Medicaid, the patient and/or their insurer and all refunds were made by March of 2012,” she wrote in an email to The Dallas Morning News.
About the same time Baylor suspended Jarrah, he lost his privileges at Texas Health Presbyterian Hospital Allen because he was not board-certified, Texas Health spokesman Wendell Watson said.
Most specialists are board-certified in their field, but it is not always a requirement at hospitals.
Jarrah continues to have privileges at other area hospitals, meaning he still can perform procedures on patients. As part of his agreement with the state, he will be temporarily monitored by another doctor.

Tuesday, September 17, 2013

Caution to Boomers: implants do not have a warranty and divorce is not an option!



                Article by: JAMES WALSH and JIM SPENCER , Star Tribune Updated: September 15, 2013 - 12:23 PM  FiDA Highlight
Rapid growth of medical devices in middle-age patients renews lives, remakes industry and raises worries over long-term use.
                7
Jay Alva’s sneakers pounded the treadmill, set to the speed of a brisk walk. Sweat dripped off the 53-year-old as he hit a groove during a recent workout.
For almost two decades, the youth soccer and football coach from Eagan moved like a man who needed a walker. A degenerative hip condition prevented Alva from running with his players or even doing basic things like tying his shoes.
Brushing off a doctor’s advice that he was “too young,” Alva got artificial hips four years ago. Now pain-free, he moves with the energy of a man in his 30s, amused at the notion that he wasn’t old enough for such treatment.
“I am living so much better now in my 50s than I did in my 40s,” Alva said.
Hundreds of thousands of Americans are receiving medical devices that were once considered nearly exclusive to the elderly. The shift is profoundly changing patient care and expanding the fortunes of the medical-technology industry while amplifying concerns over the safety and oversight of some products.
The movement is so dramatic that the futures of major medical device companies such as Medtronic, St. Jude Medical and Boston Scientific — corporate giants in Minnesota — are increasingly tied to younger groups and the new markets they represent.
Middle-age Americans, in particular, are driving this trend as they seek ways to remain physically active. The number of patients ages 45 to 64 who had a hip replacement more than doubled from 2000 to 2010, according to a Star Tribune analysis of data from the U.S. Department of Health and Human Services. The increase was more pronounced for knee replacements, rising 213 percent.
“This is huge,” said Dr. Robert Hauser, a cardiologist at the Minneapolis Heart Institute who has studied the safety and effectiveness of heart devices for years. “I think it’s a tremendous step forward, but there are issues that need to be dealt with.”

Though widely celebrated, some treatments have been shadowed by reports of devices or other medical products faltering — defective wires in defibrillators, failing artificial hips and leaky drug pumps, among them. Patients have suffered complications, severe pain and even death. Every year, 25 to 40 medical devices are recalled due to high risk — meaning a patient’s life could be in jeopardy.
Device companies are facing thousands of patient lawsuits challenging the safety of some devices, and federal regulators are under greater pressure to intensify their oversight. At the same time, device makers are spending millions to promote their products to doctors and patients while simultaneously pushing to simplify governmental reviews to quicken their products’ path to market.
Doctors and device makers are converting technology to regulate heart rhythms or treat diabetes into new tools for a wider range of ailments, including overactive bladders, anxiety and migraines. The result is a wider range of devices and other medical products being implanted or connected to more nonelderly patients.
But this growing use of medical hardware should be tempered by a call for safety, public disclosure and caution, consumer advocates say.
“We’re not talking about computers or cars or toasters,” said Lisa McGiffert, director of the Consumers Union’s Safe Patient Project, a group that campaigns for better medical practices. “We’re talking about things that go inside people’s bodies.”
Replacement parts — for the body
No area of medicine is seeing more younger patients turn to medical devices than orthopedics.
In 2000, one-third of the estimated 157,000 Americans who had hip or knee replacements were younger than 65. Ten years later, the number had nearly tripled to 430,000, meaning almost half of those procedures were performed on nonelderly patients.
Two contradicting forces are pushing patients toward artificial joints. The rising rate of obesity has led to more cases of deteriorating hips and knees from excess weight. And yet, more Americans are playing sports or exercising in their 30s, 40s and 50s, which puts more wear and tear on their joints.
To get active again — and quickly — patients are more willing to consider joint replacement at a younger age than they were a decade ago, said Dr. Daniel Berry, chairman of orthopedic surgery at the Mayo Clinic in Rochester.
“We’re seeing higher demand,” Berry said of younger patients who want a new hip. “And they are going to use it a lot harder than somebody who is older.”
Patients who get a device at a younger age usually must replace it more often. Each replacement means an expensive surgery, possible complications and significant rehabilitation.
“You have to find a happy medium,” Berry said. “Think about it like the tires on your car. There’s no point in getting new tires if you’re not driving … but if you speed up, they wear out faster.”
Medical device companies are working to create joints that are more durable and feel more like the original. Stryker, an international medical device company based in Michigan, had younger customers in mind when it developed hip and knee products that have more natural range in motion, said Joe Cooper, Stryker’s director of global communications.
“Designing implants that return this active and high-demand patient population to their lifestyles and everyday activities is a priority,” he said.
TGS Knee Innovations, a start-up device company in Plymouth, created a partial-knee replacement system that is designed to be a good option for younger patients facing a knee replacement, said Wesley Johnson, the company’s co-founder.
TGS has a relatively “small footprint” in the orthopedic field, but Johnson sees a future filled with youthful patients who want new knees to do more than they did before.
“For orthopedics, that tidal wave is a broader patient population with higher expectations,” he said.
They don’t last forever
Most artificial hips have a life span of 15 to 20 years, depending on how much patients weigh and how hard they push their bodies. Some companies developed a hip that used all-metal components in the belief it would improve durability. It didn’t necessarily turn out that way.
Many patients reported problems that have included loosening of the hip, dislocation and metal particles circulating in the bloodstream. They question whether the U.S. Food and Drug Administration, which has oversight of medical devices, adequately scrutinized the devices before approval.
Terri Wagner-Morley of St. Paul had what is commonly referred to as a metal-on-metal hip — produced by DePuy Orthopedics Inc. — implanted in 2008. Within two years, the hip began “popping.” Soon, the pop turned to pain.
Wagner-Morley had the hip removed, but infection prevented doctors from putting in a new one. Plastic “spacers” were implanted instead, and she was bedridden. Last summer, she had a metal and ceramic hip implanted, but a stress fracture during rehabilitation has left the 55-year-old woman limping and angry. She remains disabled and without a job.
“I have had four surgeries now,” Wagner-Morley said. “As I get older, I’m probably going to be wheelchair bound. I might have a positive view, but really, I’m pissed off.”
In 2010, DePuy recalled the hip that had been implanted in Wagner-Morley.
That same year, hospitals, patients and med-tech companies reported 230,000 adverse events involving medical devices. About 30,000 of those incidents resulted in hospitalization, according to an analysis by DeviceMatters, a company which interprets data on medical devices.
“You’ve got to get this right — or people are going to suffer,” said Hauser, who discovered flaws in the wires of some defibrillators that led to a major recall.
Alva said he doesn’t worry about complications or the durability of his new hips. Being able to pace the sideline of his son’s games, ride a bike or refinish his floors overrides such concerns.
“When I need [new hips] again, I’m confident the technology will be better,” Alva said. “How can it not be?”
Something old, something new
Minnesota’s med-tech giants — Medtronic, St. Jude Medical and Boston Scientific — have generated billions in sales over the past 15 years through the development of devices and technology designed to keep the heart beating in aging patients.
Now they are expanding those innovations to treat a variety of other ailments, many afflicting patients who haven’t reached their golden years.
Brent Peterson, a former professional hockey player and coach who lives in Nashville, relies on a small, pacemaker-like gadget to calm his Parkinson’s symptoms by sending a stream of electricity to a spot deep within his brain.
The 55-year-old is a special adviser to the Nashville Predators of the National Hockey League. He learned that he had Parkinson’s disease more than a decade ago. At one point, he was taking 25 pills a day.
When Peterson’s device was implanted in 2011, his hands immediately relaxed, and his movements steadied. “The day they turned it on, I knew I didn’t want to be without it ever again,” he said.
Medical device makers didn’t set out to adapt pacemakers to treat other parts of the body, but it made sense to expand the technology as doctors explored what else could be treated with an electrical pulse, said Martin Gerber, senior research and development director at Medtronic.
Peterson’s device, a Medtronic Activa neurostimulator, can be programmed and adjusted to change as his symptoms evolve. More than 100,000 patients worldwide have received Medtronic’s deep-brain stimulation therapy.
The treatment is part of what is called neuromodulation. Implanted devices are used to send medication or electrical pulses into the brain or to the spine to block pain, relax overactive bladders by targeting nerves near the tailbone or ease chronic migraines at the base of the skull. Researchers are exploring electrical stimulation to treat epilepsy, obsessive-compulsive disorder and severe depression for those who have not responded to medication.
The emerging innovations are expanding the products and profits for medical device makers.
At Fridley-based Medtronic, the world’s largest medical-technology company, nearly half of its $16 billion in revenues last fiscal year came from treating something other than the heart, its core market. And at St. Jude Medical, based in Little Canada, officials expect sales from the company’s nonheart rhythm products to surpass the heart rhythm business this year.
Med-tech executives say they are not specifically targeting young patients with these technologies. But they acknowledge these new treatments are attracting younger patients.
“It’s a tremendous growth opportunity,” St. Jude Medical Executive Vice President John Heinmiller said. “How can we innovate those technologies to attack these expensive epidemic diseases that are out there? We are looking at investments that treat a broad patient population.”
Most patients — more than 14,000 estimated in 2010 — who turn to spinal, brain or other stimulation devices are well below retirement age. Of those patients who had a spinal cord stimulator implanted, an estimated 69 percent were younger than 64, with more than 21 percent between the ages of 18 and 44.
Dr. Mehul J. Desai, director of spine, pain medicine and research at Metro Orthopedics & Sports Therapy in Silver Spring, Md., believes the numbers will continue to climb.
“There has been a push by clinicians to think about these therapies earlier on,” he said.
Marketing vs. patient demand
Medical device makers invest heavily to promote their devices to doctors, health organizations and patients.
The average marketing budget for companies of various sizes was $14.4 million in 2013, according to a survey of medical device executives by Medical Marketing & Media.
Most of those funds will not be spent on consumer education, according to the marketing survey. Instead, promotional budgets will focus on persuading health care professionals to use a particular brand of device on their patients.
Medtronic’s advertising and promotional spending in 2012 exceeded $128 million, according to Carol Greenhut, president of Schonfeld & Associates, which produces reports on medical device marketing for clients. That same year, Greenhut said, St. Jude Medical spent nearly $45 million and Boston Scientific $20 million.
Medtronic and Boston Scientific declined to confirm those figures, offer their own or discuss their marketing strategies. A St. Jude spokeswoman said Schonfeld & Associates’ figure “significantly overestimates our advertising and marketing expenses,” but she declined to provide an alternative.
Advocates for more extensive testing say device makers’ promotional emphasis remains on sales, not safety.
“One thing is obvious: They spend a lot more on advertising and lobbying than they spend on testing,” said Diana Zuckerman, president of the National Research Center for Women & Families.
But it remains unclear whether corporate marketing is driving the expanded use of medical devices. Certainly, more doctors are willing to consider them before other options have been exhausted.
In many cases, doctors remain hesitant because they simply don’t know how long a device will last and under what conditions, said Joseph Galato­witsch, president of Dymedex, a consulting firm that works with medical technology companies.
“The tension is that clinicians want to use these technologies in younger patients,” Galatowitsch said. “But they feel frustrated because they feel forced into weighing the risk versus the benefit.”
In the spine business, where many patients begin experiencing pain in their 40s and 50s, Medtronic is seeing a growing demand for more options, depending on their activity, said Rob Fredericks, vice president of global marketing, R&D and strategy for Medtronic Spinal.
For some, the stability of spinal fusion, in which vertebrae are fused together to relieve back pain after a disc has been damaged, might be the way to go. For others who seek greater range of motion, artificial discs may be the best option.
“They want to get back on their feet, back to work, back to activity — more quickly,” Fredericks said. Doctors say a patient’s age — and how the patient intends to spend his or her remaining years — weighs heavily over the decision to implant a device.
For Doug McConnell, that meant finding a way back into the water. The 55-year-old from Barrington, Ill., is an open water swimmer, swimming hours at a time through tough waves and inclement weather. So, when he suffered two herniated discs in his neck in late 2009, he wanted alternatives to the lengthy downtime and loss of mobility from spinal fusion.
“Quite apart from swimming, I wanted to be able to stay active — work in the garden and play catch with the kids,” he said. Then a Chicago physician suggested he try “this whiz-bang thing from Medtronic.”
An artificial cervical disc — the Prestige — was implanted. Six weeks after surgery, McConnell was back in the water. Eight weeks after that, he finished a 10-kilometer race.
A year after surgery, McConnell swam across the English Channel.
“It never occurs to us that we have to dial back our activities or interests,” he said. “We can anticipate living a lot longer than our parents … and we want to be able to take advantage of that.”
‘You gave me my life’
Peter Quimby of Plymouth likes to say that he’s “the healthiest dying person you’ll ever know.”
Quimby is waiting for a heart transplant. He received an implanted defibrillator and a left ventricular assist device in 2011 to help his weakened heart pump blood. Doctors told him not to overexert himself — don’t run, just shuffle.
To hell with that, Quimby says. The former paratrooper and college baseball player who graduated from West Point uses the devices to get in a good workout — and prove a point.
Six days a week, he sweats through intense workouts. He teaches a spinning class at the Andover YMCA. Recently, he finished the Minneapolis Duathlon, which combines a 15-kilometer bike race with two 5K runs — all while wearing a cumbersome device with wires that extend from his abdomen and batteries tucked into a shoulder holster.
Nobody knows whether the devices will hold up. Quimby said he won’t stop. “You didn’t give me a life,” he tells doctors and device makers. “You gave me my life.”
Federal regulators say their primary mission is to determine whether a technology is safe and saves lives — not address longevity or durability, said Christy Foreman, who directs the Office of Device Evaluation in the Center for Devices and Radiological Health at the Food and Drug Administration (FDA).
“The pacemakers that we had in 1976 were often times implanted in the abdomen because they were so big. And their battery didn’t last as long,” Foreman said. “We wouldn’t say no to the pacemaker … because we thought it was too big or didn’t last the entire patient life because we know that it is lifesaving technology. So we have to review it for what it is.”
The FDA also doesn’t regulate how physicians use medical devices. By law, doctors are allowed to use devices in any way they think will benefit their patients, even if the FDA never approved or cleared the device for that purpose.
Ralph Hall, a University of Minnesota law professor who has worked as a liaison between medical technology companies and the FDA, said the current regulatory approach will have to change as the trend toward younger patients builds momentum. It may not have been critical to assess how long a device would last in an older patient population, he said, but a wave of younger patients requires new ways of determining the life span of devices. The marketplace will demand it.
“This is going to require changes in testing methodology — less on human clinical study and more on bench testing and computer simulations and other types of tools assessing long-term performance,” Hall said.
Ultimately, it is up to the patient to decide whether to follow a doctor’s orders or the manufacturer’s recommended ways to use the device.
Dr. David Feldman, Quimby’s cardiologist, is seeing more young patients who need heart devices. Many want a treatment that will last forever.
Feldman explains that medical devices don’t work that way.
“What electronic piece of equipment that you buy now do you expect to last more than five years?”

Staff writer Glenn Howatt contributed to this report.
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