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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Sunday, September 9, 2012

Patient Last To Know About Implant Danger

September 7, 2012  The New York Times

Monsters attacked Avery de Groh when she was 4. That is how she remembers the day in 2007 when the defibrillator in her chest misfired, sending nine electric shocks through her body in less than 30 minutes.

Molly de Groh and her children Oliver, left, and Avery all have defibrillators implanted. When Avery’s misfired, repeatedly shocking her, doctors tried to fix it. Now they fear it could do it again.
Today, Avery is a chatty 9-year-old who just learned to roller-skate. She is old enough to know that she was not really attacked by monsters. The culprit was a broken wire from the defibrillator that keeps her heart beating normally. Like her mother and two brothers, she has an inherited condition that makes her prone to a fatal heart rhythm. After Avery’s episode, doctors removed the faulty wire, made by Medtronic, and replaced it with a new one made by St. Jude Medical.
Now it is possible that one is damaged, too. The wire, or lead, known as the Riata, was recalled in December after St. Jude warned doctors that internal cables were poking through the outer casing, causing unwanted shocks or failing to work when needed. Nearly 20 percent of the 128,000 people worldwide who have the Riata may be affected, according to the company.
Molly de Groh, Avery’s mother, said she worried that Avery’s new lead would also malfunction. “When I think about how scary it was for her,” she said, “I feel like, give that to me, and let her be fine.”
Heart device specialists have struggled for months to determine how best to treat patients with damaged leads. There is no easy fix: removing the wires can be dangerous, but so can leaving them in. In August, the Food and Drug Administration recommended that all patients with the Riata undergo imaging to see if their lead was failing. But the guidelines did little to settle the matter after some doctors questioned the wisdom of the advice.
Patients are caught in the middle, forced to grapple with life-or-death decisions for which there are no easy answers.
Mark Ulrich has decided not to wait. Several years ago, Mr. Ulrich’s defibrillator misfired in reaction to a medication he was taking. “I was pretty well barbecued,” said Mr. Ulrich, who is 68 and lives in Manhattan. “I would rather not be turned into a shish kebab.”
Dr. Jeffrey N. Rottman, a heart device specialist at Vanderbilt University, said most of his patients with damaged leads had elected to have them removed. “I think people who have a defibrillator already have a ‘just fix it’ type of approach,” he said.
That was Jacob Everidge’s attitude. Mr. Everidge, a 23-year-old from Athens, Ala., who has a condition that thickens the heart muscle, had his Riata removed by Dr. Rottman on Aug. 20. “I would much rather go ahead and get it out,” he said. “It wasn’t even a decision.”
For now, Ms. de Groh said, she will follow her doctor’s advice to wait and see if Avery’s lead begins to fail. But that raises other painful questions. Should the de Grohs cancel a family vacation in the Catskills, where they’ll be a half-hour from the nearest hospital? Can they send Avery to a sleepover? “As a mom of a fourth grader, I’ve got to send her to school,” said Ms. de Groh, a nurse in McHenry, Ill., a small town northwest of Chicago. But “for her not to be in my sight at all times is scary.”
Ms. de Groh and all three of her children were born with Long QT syndrome, which can cause their hearts to beat abnormally. She has a defibrillator made by Boston Scientific. Her 5-year-old son, Oliver, has the Durata, a newer lead made by St. Jude, whose safety has also been questioned recently. Her younger son, 3-month-old Monty, is too young for the operation, but he will eventually need a defibrillator, too. Because of her family history, Ms. de Groh has traveled twice to Washington to lobby lawmakers on device safety, but said she learned of the Riata recall only in August, after reading a newsletter written by a patient advocacy group.
She said she was angry at the F.D.A. and St. Jude for not contacting patients directly. “When something is implanted in a body, especially a child’s body, how can I find out about it through a newsletter?” she asked. Avery’s doctor, Marc Ovadia, said he chose not to tell Ms. De Groh about the recall because Avery’s lead is functioning “perfectly” and replacing it would require cracking open her chest. Telling patients about the recall, he said, could lead to unnecessary worry. “We want to make sure before we yell ‘fire’ in a crowded theater that this is fire,” he said. Still, he said, he regrets that Ms. de Groh found out about the recall the way she did. “These are tough, tough issues,” he said.
Mrs. de Groh’s frustration echoed that of consumer advocates who have criticized manufacturers and the F.D.A. for what they said was inadequate testing of medical devices before approval and a chaotic system for identifying problems once they are on the market.
In one example of the conflicting information about the devices, St. Jude reported last November that the problem with the Riata leads was affecting less than 1 percent of patients. But an internal report by an F.D.A. employee that month challenged that assessment, arguing that the company was underestimating the problem. The agency did not publicize the report, which was obtained through a Freedom of Information Act request and provided to The New York Times by a lawyer whose client is suing St. Jude.
The F.D.A. analysis proved to be correct: in July, a new St. Jude study found that the Riata showed signs of failing in 19 percent of patients.
The F.D.A. declined to comment on the report, other than to say that it was not unusual for the agency and the manufacturer to evaluate safety risks differently. Mitchell Shein, a manager in the F.D.A.’s division of cardiovascular devices, said deciding when to communicate with the public was often a tough call. “We’re very, very cautious to enter the public discourse on a medical issue unless we think we have something to add to that,” he said.
In addition to its recommendations that all patients with the Riata undergo imaging tests, the agency also ordered St. Jude to conduct additional studies on the Riata, which is no longer sold, and the Durata. Both were designed to be thinner than competing leads sold by Boston Scientific and Medtronic, making them easier to guide through blood vessels.
The Durata is made with a new coating that the company said seemed to have fixed the issue, but a study by a leading heart researcher has recently called that into question.
When a defibrillator is implanted, the lead is threaded through a blood vessel until it reaches the heart. In time, scar tissue can build up around it, making removal risky. The agency advised against removing the leads pre-emptively and said patients who had not experienced problems should undergo regular monitoring.
Some doctors have challenged the recommendation against routinely removing the leads, arguing that they can cause other problems when left in, like interfering with replacement leads. “There are potential risks associated with all options,” said Dr. Laurence Epstein, a heart device specialist at Brigham and Women’s Hospital in Boston.
Dr. Ovadia, a heart device specialist at Advocate Lutheran General Children’s Hospital outside of Chicago, said he did not know that the F.D.A. was recommending that all Riata patients undergo imaging tests until a reporter told him about the agency’s advice. And he said a St. Jude sales representative did not inform him of the new recommendations in a conversation in late August.
A St. Jude spokeswoman said the company notified doctors about the F.D.A. recommendations in a letter posted to its Web site, which it also sent to St. Jude field representatives. The letter explained the F.D.A.’s position on imaging, but also noted the issue was “complex and needs to take into account additional patient circumstances.”
In a separate statement, St. Jude said the company “continues to work closely with the F.D.A. and communicate important information with accuracy and integrity in a timely manner to inform patient care.”
Ms. de Groh said her thoughts had been turning to her baby, Monty. For now, he takes beta blockers to regulate his heartbeat. Common sense would tell her that he should receive a defibrillator when he is old enough. After all, medical devices fail in only a tiny percentage of cases.
“They’re supposed to save their life, but all it’s done in our family is cause problems,” Ms. de Groh said. “So you’re really conflicted as a parent on how to treat your kid if these devices are going to constantly be a source of fear and worry.

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