Power morcellation ban unlikely, but other FDA restrictions coming soon
The doc spearheading the antimorcellation campaign says FDA is divided, as are gynecologists
Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts
Sunday, November 9, 2014
Power morcellation ban unlikely, but other FDA restrictions coming soon
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| Johnson & Johnson's Ethicon division's power morcellation device, which has been recalled since the controversy errupted--Courtesy of Johnson & Johnson |
Cardiac surgeon Hooman Noorchashm and wife, Amy Reed, an anesthesiologist, have led the charge against the controversial surgical technique performed using the drill-like power morcellator. Power morcellation can upstage preexisting uterine cancers like uterine sarcoma to fatal levels.
Noorchashm and Reed have sparked public outcry, an FDA safety notice and a recall of power morcellators by former market leader Johnson & Johnson ($JNJ) via efforts like a petition on Change.org. Now they are aiming to take the campaign to its logical conclusion by securing an FDA ban of the device. That does not appear likely, according to information Noorchashm has received from a source within the FDA, who he wouldn't name during an interview.
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"The imminent plan that the CDRH has is to sugarcoat this thing using a probationary mechanism. That would deflect any sort of criticism away from 510(k). It would deflect public criticism of anyone who says FDA didn't do anything. CDRH can comes out and says, 'Well we did something. We put out an FDA advisory and we put the device under probation.' That basically will give industry a chance to recover from an absolute medical atrocity," he said.
It is unclear what a probation would entail. During the FDA's public hearing on power morcellation, the agency discussed solutions such as enhanced informed consent requirements, the use of a surgical bag during morcellation and the need for improved testing of uterine sarcoma prior to surgery. A ban of power morcellators was also on the table, although agency officials didn't seem too intent on that option.
Central to the debate is the prevalence ratio of uterine sarcoma prior to power morcellation. The FDA estimates that the ratio is one women in 350.
A well-publicized paper in the Journal of the American Medical Association estimated that the rate of uterine cancer in women who underwent morcellation was one in 370. However, uterine sarcoma is a rare subset of uterine cancer that is more difficult to detect prior to surgery than other cancers of the uterus. Uterine sarcoma specifically is the main cause of concern among the FDA and other public health experts.
The paper's author, Dr. Jason Wright of the Columbia University College of Physicians and Surgeons, said in an email to FierceMedicalDevices that he is unable to separate sarcomas or other subtypes of uterine cancer based on the insurance database. But he added, "I would assume that most cancers (in the sample) were not known preoperatively in women who underwent morcellation."
"Physicians who are defending this are saying the incidence (of uterine sarcoma in women undergoing morcellation) is one in 7,500," Noorchashm said, referring to research by obstetrician-gynecologist Elizabeth Pritts of the Wisconsin Fertility Institute.
Pritts spoke at the FDA public hearing and believes the agency is wildly overestimating the prevalence of uterine sarcoma because the agency used confirmation bias in its literature review used to arrive at its estimate of one in 350 women.
To add to the complexity, most experts assume that power morcellation poses a great chance of upstaging preexisting uterine sarcoma to fatal levels because it shreds and spreads the cancerous tissue to new parts of the body. However, in October Pritts and medical colleagues published a paper in the Journal of Minimally Invasive Gynecology concluding "there is no reliable evidence that morcellation (power or otherwise) significantly results in tumor upstaging."
"The new data by Dr. Pritts et al reveal that there is no proof that uterine morcellation upstages cancer. This is a critical discovery and changes the framework for discussion of how to care for the 31 million women with symptomatic fibroids," said gynecologic surgeon Antonio Pizarro in Shreveport, LA in an email. "Dr. Wright has issued a report of lapses in preoperative diagnosis for women with detectable cancers, not a report on sarcoma on women with fibroids."
Other members of the field favor strict action against power morcellators. "What you do about it is: you stop," said Robert Graebe, chairman and program director of the Department of Obstetrics and Gynecology at NJ-based Monmouth Medical Center in a prior article in The Wall Street Journal, adding "it's not worth playing Russian roulette with the patient."
So far the FDA has only banned one device. In 1983 it outlawed prosthetic hair fibers.
"The FDA is considering a great deal of information, including the panel's input, all comments from the public docket, and all relevant available data, in determining any future regulatory action. If the FDA decides to take further action, we will issue communication to inform manufacturers and the public, including notice in the Federal Register," said an FDA spokeswoman in an email to FierceMedicalDevices.
Meanwhile, the Democrat & Chronicle reports that a third Rochester, NY, woman has recently died of an undetected cancer two years after undergoing power morcellation.
- here is the email
- here's the article in the Democrat & Chronicle
- here's Dr. Pritt's paper abstract
Related Articles:
Physicians defend power morcellator devices amid industry fallout
Johnson & Johnson pulls power morcellator devices amid industry and regulatory backlash
Upcoming study to dispute FDA's data on power morcellation risk
FDA panel recommends stronger labeling, limiting use of power morcellation--agency may go further
Power morcellator fallout continues after FDA advisory warning
Tuesday, October 28, 2014
The medical establishment values profits over patient lives, as seen in Morcellation procrastination
After
George Leuzzi pays final respects to his wife on Tuesday at her
funeral, he will turn his attention to caring for their young daughter
and bringing an end to a procedure that claimed 44-year-old Brenda.
"Now that she's passed I will do my part to carry on what she started," he said. "I will help as much as I can to get this removed."
Brenda Leuzzi died 25 months after fibroid surgery through minimally invasive procedure that involved power morcellation. At the time, no one knew the fibroids, thought to be innocent growths, were cancerous. There is no definitive pre-surgery test to determine whether fibroids are benign. Power morcellation shreds tissue so that it can be removed through small incisions of minimally invasive surgery. In so doing, it can send bits of cancer to other parts of the abdomen, where they can "seed."
A grassroots effort to end power morcellation has been going on for just about a year, since the problem was brought to light by a physician whose wife had an undetected cancer worsened by the procedure.
The Food and Drug Administration has issued advisories against the procedure and the leading manufacturer, Johnson & Johnson, has asked providers to return the devices. But other manufacturers have them on the market. The FDA held hearings in July about the safety of the procedure.
The same day that George Leuzzi buried his wife, Morgan Liscinsky of the FDA press office answered a request for an update with, "I have no new information to share since you contacted me last month."
Sens. Chuck Schumer and Kirsten Gillibrand wrote in August to FDA Commissioner Margaret Hamburg. That letter was on behalf of Jim Leary of Greece, whose wife, Barbara, died last year after having undergone a procedure that involved morcellation.
Asked what the senators are doing to step up pressure, Gillibrand spokesman Jacob Fromer responded: "It is deeply frustrating to the Senator that while the FDA discourages the use of these very devices they won't take the necessary action to ban them. She will continue to communicate her concerns to the commissioner. Kirsten's thoughts and prayers are with the Leuzzi family, particularly their young daughter, Peyton."
Schumer spokesman Max Dworin said the office "followed up with the FDA (Monday), urging them again to call on manufacturers to voluntarily recall these devices, and we will continue to push."
Schumer's statement Monday read, ""The passing of Brenda Leuzzi is tragic and further underscores the urgency for all firms to voluntarily recall these devices until more thorough testing can be done. The FDA should act before another family has to experience what the Leuzzi family is going through right now. My thoughts and prayers go out to the entire Leuzzi family."
George Leuzzi is more adamant than Schumer. "I'm very disappointed in the FDA. They should have banned this by now. They're just stalling and finding some other way to convince themselves it's OK. If anybody saw Brenda and the way she died, it's pretty far from OK. I wouldn't wish it on my worst enemy."
George Leuzzi said he's received an uncountable number of texts and emails since he posted on a leiomyosarcoma Facebook page news of Brenda's death.
"Cancer is the enemy, but any procedure that would enhance it and make it worse and put someone in a position to have no way of rebounding from it is criminal," he said.
As it was during Brenda's illness, her husband's focus is on his wife.
"I want her to be remembered. I don't want her to be forgotten, especially because what she died for was completely unnecessary."
"Now that she's passed I will do my part to carry on what she started," he said. "I will help as much as I can to get this removed."
Brenda Leuzzi died 25 months after fibroid surgery through minimally invasive procedure that involved power morcellation. At the time, no one knew the fibroids, thought to be innocent growths, were cancerous. There is no definitive pre-surgery test to determine whether fibroids are benign. Power morcellation shreds tissue so that it can be removed through small incisions of minimally invasive surgery. In so doing, it can send bits of cancer to other parts of the abdomen, where they can "seed."
A grassroots effort to end power morcellation has been going on for just about a year, since the problem was brought to light by a physician whose wife had an undetected cancer worsened by the procedure.
The Food and Drug Administration has issued advisories against the procedure and the leading manufacturer, Johnson & Johnson, has asked providers to return the devices. But other manufacturers have them on the market. The FDA held hearings in July about the safety of the procedure.
The same day that George Leuzzi buried his wife, Morgan Liscinsky of the FDA press office answered a request for an update with, "I have no new information to share since you contacted me last month."
Sens. Chuck Schumer and Kirsten Gillibrand wrote in August to FDA Commissioner Margaret Hamburg. That letter was on behalf of Jim Leary of Greece, whose wife, Barbara, died last year after having undergone a procedure that involved morcellation.
Asked what the senators are doing to step up pressure, Gillibrand spokesman Jacob Fromer responded: "It is deeply frustrating to the Senator that while the FDA discourages the use of these very devices they won't take the necessary action to ban them. She will continue to communicate her concerns to the commissioner. Kirsten's thoughts and prayers are with the Leuzzi family, particularly their young daughter, Peyton."
Schumer spokesman Max Dworin said the office "followed up with the FDA (Monday), urging them again to call on manufacturers to voluntarily recall these devices, and we will continue to push."
Schumer's statement Monday read, ""The passing of Brenda Leuzzi is tragic and further underscores the urgency for all firms to voluntarily recall these devices until more thorough testing can be done. The FDA should act before another family has to experience what the Leuzzi family is going through right now. My thoughts and prayers go out to the entire Leuzzi family."
George Leuzzi is more adamant than Schumer. "I'm very disappointed in the FDA. They should have banned this by now. They're just stalling and finding some other way to convince themselves it's OK. If anybody saw Brenda and the way she died, it's pretty far from OK. I wouldn't wish it on my worst enemy."
George Leuzzi said he's received an uncountable number of texts and emails since he posted on a leiomyosarcoma Facebook page news of Brenda's death.
"Cancer is the enemy, but any procedure that would enhance it and make it worse and put someone in a position to have no way of rebounding from it is criminal," he said.
As it was during Brenda's illness, her husband's focus is on his wife.
"I want her to be remembered. I don't want her to be forgotten, especially because what she died for was completely unnecessary."
Tuesday, June 10, 2014
Consumer group questions online medical device ads
Consumer group questions online medical device ads
WASHINGTON
—
A consumer watchdog group on Wednesday questioned the legality of
several advertisements for medical devices that appear on YouTube and
called on regulators to crack down on the promotions.
Online videos from Abbott Laboratories, Medtronic Inc. and Stryker
Corp. tout the benefits of their devices, but do not mention the risks,
according to the Boston-based nonprofit group, Prescription Project.
The Food and Drug Administration requires television advertisements for
drugs and medical devices to give a balanced picture of benefits and
risks; however, it's unclear whether that law also applies to Internet
promotions, the group says.
"The videos raise serious questions about whether drug and device
companies are using the Internet to skirt laws that safeguard
consumers," said Allan Coukell, director of policy for the Prescription
Project.
In a petition submitted to the FDA, the group asks regulators to order
the companies to remove the advertisements from the Web. The group also
asks the agency to issue regulations specifying that online ads are
subject to the same standards as television ads.
Among the ads cited in the petition are an advertisement for Medtronic's artificial spine disk, Prestige.
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