Preview Newsletter
Morcellation Media Monitoring 04/18/2016
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Pennsylvania Lawmaker Wants Power Morcellators Reviewed In Cancer 'Moonshot' Initiative
Apr 15, 2016 | Grey Sheet
By Sue Darcey
Rep. Mike Fitzpatrick, R-Pa., continues his campaign to use cancer cases that may have been initiated by power morcellators as a hammer to bring about tougher review of devices causing harm. Specifically, he sent a letter April 14 to Vice President Joe Biden asking him to use the cancer "moonshot" project to enact tougher safety reviews of any medical technology products that could have carcinogenic effects. -
FITZPATRICK LETTER TO VICE PRESIDENT URGES POWER MORCELLATOR REVIEW IN ‘CANCER MOONSHOT’ INITIATIVE
Apr 15, 2016 | Congressman Mike Fitzpatrick
WASHINGTON, D.C. – Congressman Mike Fitzpatrick (PA-8) Wednesday called on Vice President Joseph Biden to take action on reforming medical device review and monitoring processes as part of the Administration’s “Cancer Moonshot” initiative – specifically highlighting power morcellators. -
FDA approves morcellation containment system
Apr 13, 2016 | Modern Medecine
By Judith M. Orvos ELS and Miranda Hester
The US Food and Drug Administration (FDA) has given the nod to a first-of-its-kind tissue containment system for use with certain laparoscopic power morcellators. Advanced Surgical Concepts Ltd., the manufacturer of the Pneumoliner, is required to warn patients and health care providers that the device has not been proven to reduce risk of spreading cancer during tissue morcellation. -
FDA Approves Morcellator Bag to Prevent Cancerous Tissue Spread
Apr 12, 2016 | Drug Watch
By Michelle Llamas
The U.S. Food and Drug Administration allowed an Irish company to market its new power morcellator tissue collection system. The bag is one-of-a-kind and promises to trap potentially cancerous tissue and prevent it from spreading in the body during laparoscopic hysterectomies and fibroid removals. -
FDA Inspects Hospitals for Morcellation Harm; Congressman Draws VP Biden's Attention to Issue
Apr 15, 2016 | The Cancer Letter
By Matthew Bin Han Ong
FDA has conducted inspections of several hospitals—including Brigham & Women’s Hospital—based on allegations that physicians and administrators did not report patient harm and deaths resulting from power morcellators.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Morcellation
Full Text of Stories Below
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Pennsylvania Lawmaker Wants Power Morcellators Reviewed In Cancer 'Moonshot' Initiative
Apr 15, 2016 | Grey Sheet
By Sue Darcey
Rep. Mike Fitzpatrick, R-Pa., continues his campaign to use cancer cases that may have been initiated by power morcellators as a hammer to bring about tougher review of devices causing harm. Specifically, he sent a letter April 14 to Vice President Joe Biden asking him to use the cancer "moonshot" project to enact tougher safety reviews of any medical technology products that could have carcinogenic effects.
Other groups have also been petitioning cancer moonshot project leaders to consider their products for inclusion in the fight against cancer. AdvaMed, for instance, sent a letter to Biden about medical technology's contributions to the anti-cancer effort on March 31. (See "Device-Makers Can Help With Cancer ‘Moonshot,' AdvaMed Tells Biden" — "The Gray Sheet," Apr. 1, 2016.) But Rep. Fitzpatrick is attempting to leverage the initiative to restrict use of the technology.
"Power morcellators are FDA-cleared medical devices that are used to remove uterine fibroids. For over two decades, morcellation was marketed as a safe, routine procedure. However, if a uterine fibroid is harboring an undetectable cancer, the morcellation of that cancerous tissue and its removal through the abdominal cavity can spread that cancer," Fitzpatrick told Biden.
"While supporting the development of new devices to target cancer, we must ensure that the FDA is able to review, monitor and quickly take action should those devices do harm," the congressman cautioned.
Fitzgerald's focus on power morcellators was sparked by two of his constituents in Philadelphia, anesthesiologist Amy Reed and her husband, cardiothoracic surgeon Hooman Noorchasm. Reed had a hysterectomy with a power morcellator for fibroid removal in late 2013 that she and Noorchasm said led to development of a malignant uterine cancer tumor. Both have spoken out to physician and patient groups across the US and have launched an advocacy campaign advising against use of the morcellators.
FDA advised health-care providers to stop using power morcellators for hysterectomy or myomectomy in most women with uterine fibroids in April 2014. (See "FDA Warns Against Power Morcellators For Uterine Fibroid Surgery" — "The Gray Sheet," Apr. 17, 2014.) The agency added a black-box warning to labeling and issued a safety communication for the devices later that year, stating that the devices are contraindicated for use in peri- and post-menopausal women or in candidates for intact removal of the tissue through the vagina or mini-laparotomy incision.
However, the move by FDA has remained controversial with gynecologists, who challenged FDA over the statistics the agency relied on with regard to additional uterine cancer cases linked to power morcellation in 2015. (See "Ob/Gyn Specialists Ask FDA To Soften Power Morcellation Warning" —"The Gray Sheet," Dec. 10, 2015.) Fitzpatrick previously requested that FDA's criminal division investigate Ethicon Inc.'s conduct in marketing the fibroid-removal devices in a Dec. 18 letter to the agency, although its parent company Johnson & Johnson halted its sales of morcellators following the first FDA warning in April 2014. (See "Lawmaker Asks FDA To Launch Criminal Inquiry Into Power Morcellators" — "The Gray Sheet," Jan. 5, 2016.)
The congressman has been active on other device health and safety issues as well. He introduced the E-Free Act, H.R. 3920 in the House on Nov. 4, which calls for the market withdrawal of the controversial permanent sterilization device Essure, sold by Bayer HealthCare LLC. Fitzpatrick criticized FDA for not taking any enforcement actions against Bayer, but, instead, calling for additional postmarket studies of the device. (See "FDA Essure Actions Draw Lawmaker Ire, Demand For Product Withdrawal" — "The Gray Sheet," Feb. 29, 2016.)
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FITZPATRICK LETTER TO VICE PRESIDENT URGES POWER MORCELLATOR REVIEW IN ‘CANCER MOONSHOT’ INITIATIVE
Apr 15, 2016 | Congressman Mike Fitzpatrick
WASHINGTON, D.C. – Congressman Mike Fitzpatrick (PA-8) Wednesday called on Vice President Joseph Biden to take action on reforming medical device review and monitoring processes as part of the Administration’s “Cancer Moonshot” initiative – specifically highlighting power morcellators.
“As part of the Cancer Moonshot, we have the chance to protect others from the harm caused by dangerous medical devices. In 2016 there will be an estimated 595,690 cancer deaths in the United States. We must guard against unsafe medical devices from contributing to those staggering statistics,” wrote Fitzpatrick. “While supporting the development of new devices to target cancer, we must ensure that the FDA is able to review, monitor, and quickly take action should those devices do harm. Unfortunately, we are too late for many women who, because of morcellation, were not given a fair chance to fight and beat their cancer. But we have a chance to protect others.”
The complete letter is below:
Dear Vice President Biden,
I applaud your efforts as part of the cancer Moonshot program to make cancer a thing of the past. This program will have life changing effects on the more than 14 million people living with cancer in the United States.
As part of the Cancer Moonshot, President Obama called for the development of a virtual Oncology Center of Excellence within the Food and Drug Administration (FDA). The purpose of the center is to “support the continued development of companion diagnostic tests, and the use of combinations of drugs, biologics and devices to treat cancer.” While it is critically important we support the development of innovative new devices and drugs to treat cancer, it is just as important to take this opportunity to implement meaningful reforms to make medical devices safe. Unfortunately, for decades, a medical device known as a laparoscopic power morcellator proved tragically unsafe, spread cancer throughout the body of those it was designed to help, and led to the death of hundreds, if not thousands, of women.
Power morcellators are FDA-cleared medical devices that are used to remove uterine fibroids. The blades of this device shred the uterine fibroids, which are then removed through a laparoscopic incision. For over two decades, morcellation was marketed as a safe, routine procedure. However, if a uterine fibroid is harboring an undetectable cancer, the morcellation of that cancerous tissue and its removal through the abdominal cavity can spread that cancer throughout a woman’s body. This device can take a Stage 1 treatable cancer immediately to a Stage 4 terminal cancer. And tragically for too many women, this routine procedure ended with a death sentence.
Although the risk of spreading unsuspected cancers in women is as high as 1 in 352 cases, for decades the device stayed on the market, and it was only in November 2014 that the FDA put a black box warning on the device. It took a victim of morcellation and mother of 6, Dr. Amy Reed, to get the FDA take notice. It took the families of those who lost mothers, sisters, and wives, and those who continue to battle the cancer spread by morcellation, to get the FDA to take action.
As part of the Cancer Moonshot, we have the chance to protect others from the harm caused by dangerous medical devices. In 2016 there will be an estimated 595,690 cancer deaths in the United States. We must guard against unsafe medical devices from contributing to those staggering statistics. While supporting the development of new devices to target cancer, we must ensure that the FDA is able to review, monitor, and quickly take action should those devices do harm. Unfortunately, we are too late for many women who, because of morcellation, were not given a fair chance to fight and beat their cancer. But we have a chance to protect others. We must take action.
There are simple steps we can take today to improve patient safety for tomorrow’s beneficiaries of innovative new devices. One simple way we can do this is to ensure that serious injuries and deaths caused by medical devices are promptly reported to the FDA. For years there was evidence that morcellation was spreading cancer in women. But those reports never made it to the FDA. For years women were dying from the cancer spread by this device. But their deaths were never reported to the FDA by the hospitals, the device manufacturers, or the doctors who were charged with their care.
This was despite federal requirements that FDA be informed about unsafe devices. We must do more to strengthen medical device reporting regulations to ensure that dangerous devices, like the morcellator that spread cancer in women for decades, are quickly identified and removed from the market before they can do more harm.
I applaud your leadership on this important mission that will undoubtedly save lives, and look forward to continuing to work with you to help eliminate cancer as we know it.
Please do not hesitate to contact me if I may be of assistance.
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FDA approves morcellation containment system
Apr 13, 2016 | Modern Medecine
By Judith M. Orvos ELS and Miranda Hester
The US Food and Drug Administration (FDA) has given the nod to a first-of-its-kind tissue containment system for use with certain laparoscopic power morcellators. Advanced Surgical Concepts Ltd., the manufacturer of the Pneumoliner, is required to warn patients and health care providers that the device has not been proven to reduce risk of spreading cancer during tissue morcellation.
The Pneumoliner consists of a containment bag and tube-line plunger to deliver the abdominal cavity. The tissue to be removed is then placed in the bag and the bag is sealed and inflated. Inflation creates a working space around the tissue and visualization during morcellation to help prevent breakage of the containment bag by the morcellator tip or other surgical instruments.
The device was tested in “worst-case” scenarios and found to be impermeable to substances similar in molecular size to tissues, cells and body fluids. Other testing showed that inflation of the bag provided adequate space for surgeons performing morcellation with good visualization, and under stress testing, it was found to withstand forces in excess of those expected to occur in actual clinical use.
The labeling for Pneumoliner underscores that the device is not to be used on tissue to be morcellated that is known or suspected to contain malignancy. It is also not intended for use on uterine tissue that contains suspected fibroids in women who are perimenopausal or postmenopausal or those who are candidates for en bloc tissue removal. It was approved through FDA’s de novo classification process, a regulatory pathway for some novel, low- to moderate-risk medical devices that are first-of-a-kind.
Commenting on the approval, William Maisel, MD, MPH, deputy director for science and chief scientist at FDA’s Center for Devices and Radiological Health said, “This new device does not change our position on the risks associated with power morcellation. We are continuing to warn against the use of power morcellators for the vast majority of women undergoing removal of the uterus or uterine fibroids.”
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FDA Approves Morcellator Bag to Prevent Cancerous Tissue Spread
Apr 12, 2016 | Drug Watch
By Michelle Llamas
The U.S. Food and Drug Administration allowed an Irish company to market its new power morcellator tissue collection system. The bag is one-of-a-kind and promises to trap potentially cancerous tissue and prevent it from spreading in the body during laparoscopic hysterectomies and fibroid removals.
Advanced Surgical Concepts Ltd developed the tissue containment system for use called the PneumoLiner last year. Before performing minimally invasive surgery witha power morcellator, surgeons insert the tissue bag into the abdomen with a tube-like plunger. Surgeons place the tissue they intend to morcellate in the bag. The bag is then inflated and sealed, trapping all bits of tissue and fluids for removal.
While the FDA approved the bag for sale, it stands by its 2014 warning that power morcellators used to cut up tissue into small chunks during minimally invasive surgery are still risky for the majority of women. As many as 1 in 350 women may have undiagnosed uterine cancer that can be cut up and spread in the body by morcellators.
Johnson & Johnson pulled their three morcellators off the market after the warning, but about 30 women filed lawsuits against the company’s Ethicon unit claiming their cancer was worsened by the devices.
“The PneumoLiner is intended to contain morcellated tissue in the very limited patient population for whom power morcellation may be an appropriate therapeutic option – and only if patients have been appropriately informed of the risks,” William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, said in a statement. “This new device does not change our position on the risks associated with power morcellation. We are continuing to warn against the use of power morcellators for the vast majority ofwomen undergoing removal of the uterus or uterine fibroids.”
The new bag is not guaranteed to stop the spread of cancer. In fact, the packaging of the product must also list several warnings, including one that reads, “The use of this containment system has not been clinically demonstrated to reduce this risk.”
FDA also requires physicians to complete a company training program before using the containment system.
Bag Leakage Still Possible
There is no proof the PneumoLiner is effective, and one new study shows tissue and fluid could still leak from the bag.
The February 2016 study published in the American Journal of Obstetrics and Gynecology by Cohen et al. revealed nearly 1 in 10 containment bags could leak fluids and tissue. In the study, seven out of 76 patients had fluid spread, but the study did not name the containment system used.
“These instances do represent potential opportunities for tissue dissemination,” the authors wrote. However, they add that in traditional surgical techniques there is also a chance for fluid spread and recommended further refinement of the containment technique.
Frank Bonadio, Advanced Surgical’s CEO, said the PneumoLiner is safe and provides complete containment.
Morcellator Controversy Continues
Controversy surrounding power morcellators began after the FDA issued its 2014 warning, and a number of doctors are still divided.
Some argue the devices cut down on complications and recovery time from traditional surgeries. Others like Dr. Hooman Noorchashm — whose wife, Dr. Amy Reed was diagnosed with leiomyosarcoma after a morcellator hysterectomy — want morcellators removed from the market.
“FDA ought to have classified this as a [high-risk] Class III device and taken it through the Premarket Approval process,” said Noorchashm in an email to Peter Lurie, the FDA associate commissioner for public health strategy and analysis.
Shortly after the FDA warning, Johnson & Johnson’s Ethicon unit withdrew its devices from the market. Several insurance companies stopped paying for the procedure and a number of hospitals stopped using the devices.
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FDA Inspects Hospitals for Morcellation Harm; Congressman Draws VP Biden's Attention to Issue
Apr 15, 2016 | The Cancer Letter
By Matthew Bin Han Ong
FDA has conducted inspections of several hospitals—including Brigham & Women’s Hospital—based on allegations that physicians and administrators did not report patient harm and deaths resulting from power morcellators.
In a March 29 letter to Rep. Mike Fitzpatrick (R-Pa.), the agency said it “takes these issues very seriously.”
“In recent months, we have conducted inspections of hospitals highlighted in your letter, including Brigham & Women’s Hospital, Rochester General Hospital, and the University of Rochester Medical Center,” FDA officials wrote, responding to a Dec. 18, 2015, letter from Fitzpatrick to the agency’s Office of Criminal Investigations.
Under Section 803 of Title 21 of the Code of Federal Regulations, manufacturers and hospitals are required to report adverse outcomes—deaths and serious injuries that a device may have caused or contributed to—to FDA within 10 to 30 days.
In November 2014, The Cancer Letter first reported on Brigham’s role in upstaging a patient’s leiomyosarcoma via power morcellation performed in 2012. Erica Kaitz, the patient, died on Dec. 7, 2013. In October 2013, another patient, Amy Reed received her cancer diagnosis at Brigham. Reed subsequently led a campaign against widespread use of the procedure (The Cancer Letter, Nov. 21, 2014).
In a study by Brigham physicians Michael Muto and Michael Seidman published November 2012 in PLOS ONE, the authors identify four patients—out of 1,091 patients—who showed evidence of peritoneal dissemination of leiomyosarcoma after undergoing power morcellation. Three of the four patients died, with an average post-diagnosis survival of 24.3 months.
It is not publicly known where the four patients were treated.
Johnson & Johnson subsidiary Ethicon—the largest manufacturer of the devices—said it didn’t know of the dangers of power morcellators prior to December 2013, when Reed and her husband Noorchashm filed a Medical Device Report to FDA. Whistleblower Robert Lamparter, a retired pathologist from central Pennsylvania, disagreed, and produced documents from 2006 proving that he had reported to J&J a near-miss case as well as risk estimates similar to FDA’s numbers (The Cancer Letter, Nov. 20, 2015).
FDA said it did not receive any reports of adverse outcomes from manufacturers and hospitals prior to December 2013 (The Cancer Letter, Dec. 18, 2015).
FDA joins three other federal agencies in looking into potential violations of statutory requirements for hospitals and manufacturers to report adverse outcomes: the Federal Bureau of Investigation, the Government Accountability Office and the Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce.
“In order to protect the integrity of the investigative process, it is FDA’s policy not to confirm or deny the existence of a criminal investigation,” FDA acting associate commissioner Dayle Cristinzio wrote to Fitzpatrick. “FDA appreciates your interest in this issue and we will continue to keep you and your staff apprised of any updates.”publication date: Apr 15, 2016FDA Inspects Hospitals for Morcellation Harm; Congressman Draws VP Biden's Attention to Issue
By Matthew Bin Han Ong
FDA has conducted inspections of several hospitals—including Brigham & Women’s Hospital—based on allegations that physicians and administrators did not report patient harm and deaths resulting from power morcellators.
In a March 29 letter to Rep. Mike Fitzpatrick (R-Pa.), the agency said it “takes these issues very seriously.”
“In recent months, we have conducted inspections of hospitals highlighted in your letter, including Brigham & Women’s Hospital, Rochester General Hospital, and the University of Rochester Medical Center,” FDA officials wrote, responding to a Dec. 18, 2015, letter from Fitzpatrick to the agency’s Office of Criminal Investigations.
Under Section 803 of Title 21 of the Code of Federal Regulations, manufacturers and hospitals are required to report adverse outcomes—deaths and serious injuries that a device may have caused or contributed to—to FDA within 10 to 30 days.
In November 2014, The Cancer Letter first reported on Brigham’s role in upstaging a patient’s leiomyosarcoma via power morcellation performed in 2012. Erica Kaitz, the patient, died on Dec. 7, 2013. In October 2013, another patient, Amy Reed received her cancer diagnosis at Brigham. Reed subsequently led a campaign against widespread use of the procedure (The Cancer Letter, Nov. 21, 2014).
In a study by Brigham physicians Michael Muto and Michael Seidman published November 2012 in PLOS ONE, the authors identify four patients—out of 1,091 patients—who showed evidence of peritoneal dissemination of leiomyosarcoma after undergoing power morcellation. Three of the four patients died, with an average post-diagnosis survival of 24.3 months.
It is not publicly known where the four patients were treated.
Johnson & Johnson subsidiary Ethicon—the largest manufacturer of the devices—said it didn’t know of the dangers of power morcellators prior to December 2013, when Reed and her husband Noorchashm filed a Medical Device Report to FDA. Whistleblower Robert Lamparter, a retired pathologist from central Pennsylvania, disagreed, and produced documents from 2006 proving that he had reported to J&J a near-miss case as well as risk estimates similar to FDA’s numbers (The Cancer Letter, Nov. 20, 2015).
FDA said it did not receive any reports of adverse outcomes from manufacturers and hospitals prior to December 2013 (The Cancer Letter, Dec. 18, 2015).
FDA joins three other federal agencies in looking into potential violations of statutory requirements for hospitals and manufacturers to report adverse outcomes: the Federal Bureau of Investigation, the Government Accountability Office and the Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce.
“In order to protect the integrity of the investigative process, it is FDA’s policy not to confirm or deny the existence of a criminal investigation,” FDA acting associate commissioner Dayle Cristinzio wrote to Fitzpatrick. “FDA appreciates your interest in this issue and we will continue to keep you and your staff apprised of any updates.”
Fitzpatrick: An Example for Moonshot FDA Reform
In a letter to Vice President Joe Biden, Fitzpatrick urged the White House to implement “meaningful” reforms as part of the cancer moonshot initiative, which aims to consolidate FDA’s oncology portfolio (The Cancer Letter, Feb. 12).
Medical device reporting regulations need to be strengthened, Fitzpatrick said, and the controversy over reporting of adverse outcomes resulting from power morcellators is one situation where consolidation of cancer expertise at the agency could have life-saving impact.
“As part of the Cancer Moonshot, we have the chance to protect others from the harm caused by dangerous medical devices,” Fitzpatrick wrote in the April 14 letter. “President Obama called for the development of a virtual Oncology Center of Excellence within the Food and Drug Administration.
“The purpose of the center is to ‘support the continued development of companion diagnostic tests, and the use of combinations of drugs, biologics and devices to treat cancer.’ While it is critically important we support the development of innovative new devices and drugs to treat cancer, it is just as important to take this opportunity to implement meaningful reforms to make medical devices safe.
“Unfortunately, for decades, a medical device known as a laparoscopic power morcellator proved tragically unsafe, spread cancer throughout the body of those it was designed to help, and led to the death of hundreds, if not thousands, of women.”
The correspondence between Fitzpatrick, FDA and Biden can be downloaded here.
The moonshot program aims to provide $75 million in proposed fiscal 2017 mandatory funds would be used to “leverage the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics, and devices.” (The Cancer Letter, Feb. 12.)
An effort is underway to restructure FDA based primarily on therapeutic areas, de-emphasizing the silos of drugs, biologics and devices. This would be done through the creation of FDA Centers of Excellence, which advocates say would improve coordination between FDA medical product centers.
At a recent Capitol Hill briefing, panel members—representing industry, FDA, academic oncology and patient advocacy—agreed that the time has come to reassess the way medical products are regulated at FDA (The Cancer Letter, Feb. 26).
“First of all, there’s nothing wrong, and FDA is doing a great job with what they have,” said Ellen Sigal, chair and founder of Friends of Cancer Research, the advocacy group that convened a panel discussion to explore a way forward for the regulatory agency.
“People at Center for Devices and Radiological Health, Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research are all doing a great job. But, the question is, can it be better?” said Sigal at the Feb. 24 event. “Patients get diseases, they don’t get a biologic; they don’t get a device. It all works together. Is there a more efficient way that is better? Because the goal is to get patients better treatments. This is what it’s about.
“It isn’t about institutional structures; it’s not about anyone doing a bad job. Is there an efficient, better way to serve the patient towards the goal of really integrating these centers of people in their particular fields working together?”
The text of Fitzpatrick’s April 14 letter to the vice president follows:publication date: Apr 15, 2016FDA Inspects Hospitals for Morcellation Harm; Congressman Draws VP Biden's Attention to Issue
By Matthew Bin Han Ong
FDA has conducted inspections of several hospitals—including Brigham & Women’s Hospital—based on allegations that physicians and administrators did not report patient harm and deaths resulting from power morcellators.
In a March 29 letter to Rep. Mike Fitzpatrick (R-Pa.), the agency said it “takes these issues very seriously.”
“In recent months, we have conducted inspections of hospitals highlighted in your letter, including Brigham & Women’s Hospital, Rochester General Hospital, and the University of Rochester Medical Center,” FDA officials wrote, responding to a Dec. 18, 2015, letter from Fitzpatrick to the agency’s Office of Criminal Investigations.
Under Section 803 of Title 21 of the Code of Federal Regulations, manufacturers and hospitals are required to report adverse outcomes—deaths and serious injuries that a device may have caused or contributed to—to FDA within 10 to 30 days.
In November 2014, The Cancer Letter first reported on Brigham’s role in upstaging a patient’s leiomyosarcoma via power morcellation performed in 2012. Erica Kaitz, the patient, died on Dec. 7, 2013. In October 2013, another patient, Amy Reed received her cancer diagnosis at Brigham. Reed subsequently led a campaign against widespread use of the procedure (The Cancer Letter, Nov. 21, 2014).
In a study by Brigham physicians Michael Muto and Michael Seidman published November 2012 in PLOS ONE, the authors identify four patients—out of 1,091 patients—who showed evidence of peritoneal dissemination of leiomyosarcoma after undergoing power morcellation. Three of the four patients died, with an average post-diagnosis survival of 24.3 months.
It is not publicly known where the four patients were treated.
Johnson & Johnson subsidiary Ethicon—the largest manufacturer of the devices—said it didn’t know of the dangers of power morcellators prior to December 2013, when Reed and her husband Noorchashm filed a Medical Device Report to FDA. Whistleblower Robert Lamparter, a retired pathologist from central Pennsylvania, disagreed, and produced documents from 2006 proving that he had reported to J&J a near-miss case as well as risk estimates similar to FDA’s numbers (The Cancer Letter, Nov. 20, 2015).
FDA said it did not receive any reports of adverse outcomes from manufacturers and hospitals prior to December 2013 (The Cancer Letter, Dec. 18, 2015).
FDA joins three other federal agencies in looking into potential violations of statutory requirements for hospitals and manufacturers to report adverse outcomes: the Federal Bureau of Investigation, the Government Accountability Office and the Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce.
“In order to protect the integrity of the investigative process, it is FDA’s policy not to confirm or deny the existence of a criminal investigation,” FDA acting associate commissioner Dayle Cristinzio wrote to Fitzpatrick. “FDA appreciates your interest in this issue and we will continue to keep you and your staff apprised of any updates.”
Fitzpatrick: An Example for Moonshot FDA Reform
In a letter to Vice President Joe Biden, Fitzpatrick urged the White House to implement “meaningful” reforms as part of the cancer moonshot initiative, which aims to consolidate FDA’s oncology portfolio (The Cancer Letter, Feb. 12).
Medical device reporting regulations need to be strengthened, Fitzpatrick said, and the controversy over reporting of adverse outcomes resulting from power morcellators is one situation where consolidation of cancer expertise at the agency could have life-saving impact.
“As part of the Cancer Moonshot, we have the chance to protect others from the harm caused by dangerous medical devices,” Fitzpatrick wrote in the April 14 letter. “President Obama called for the development of a virtual Oncology Center of Excellence within the Food and Drug Administration.
“The purpose of the center is to ‘support the continued development of companion diagnostic tests, and the use of combinations of drugs, biologics and devices to treat cancer.’ While it is critically important we support the development of innovative new devices and drugs to treat cancer, it is just as important to take this opportunity to implement meaningful reforms to make medical devices safe.
“Unfortunately, for decades, a medical device known as a laparoscopic power morcellator proved tragically unsafe, spread cancer throughout the body of those it was designed to help, and led to the death of hundreds, if not thousands, of women.”
The correspondence between Fitzpatrick, FDA and Biden can be downloaded here.
The moonshot program aims to provide $75 million in proposed fiscal 2017 mandatory funds would be used to “leverage the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics, and devices.” (The Cancer Letter, Feb. 12.)
An effort is underway to restructure FDA based primarily on therapeutic areas, de-emphasizing the silos of drugs, biologics and devices. This would be done through the creation of FDA Centers of Excellence, which advocates say would improve coordination between FDA medical product centers.
At a recent Capitol Hill briefing, panel members—representing industry, FDA, academic oncology and patient advocacy—agreed that the time has come to reassess the way medical products are regulated at FDA (The Cancer Letter, Feb. 26).
“First of all, there’s nothing wrong, and FDA is doing a great job with what they have,” said Ellen Sigal, chair and founder of Friends of Cancer Research, the advocacy group that convened a panel discussion to explore a way forward for the regulatory agency.
“People at Center for Devices and Radiological Health, Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research are all doing a great job. But, the question is, can it be better?” said Sigal at the Feb. 24 event. “Patients get diseases, they don’t get a biologic; they don’t get a device. It all works together. Is there a more efficient way that is better? Because the goal is to get patients better treatments. This is what it’s about.
“It isn’t about institutional structures; it’s not about anyone doing a bad job. Is there an efficient, better way to serve the patient towards the goal of really integrating these centers of people in their particular fields working together?”
The text of Fitzpatrick’s April 14 letter to the vice president follows:
Dear Vice President Biden,
I applaud your efforts as part of the cancer Moonshot program to make cancer a thing of the past. This program will have life-changing effects on the more than 14 million people living with cancer in the United States.
As part of the Cancer Moonshot, President Obama called for the development of a virtual Oncology Center of Excellence within the Food and Drug Administration (FDA). The purpose of the center is to “support the continued development of companion diagnostic tests, and the use of combinations of drugs, biologics and devices to treat cancer.”
While it is critically important we support the development of innovative new devices and drugs to treat cancer, it is just as important to take this opportunity to implement meaningful reforms to make medical devices safe.
Unfortunately, for decades, a medical device known as a laparoscopic power morcellator proved tragically unsafe, spread cancer throughout the body of those it was designed to help, and led to the death of hundreds, if not thousands, of women.
Power morcellators are FDA-cleared medical devices that are used to remove uterine fibroids. The blades of this device shred the uterine fibroids, which are then removed through a laparoscopic incision. For over two decades, morcellation was marketed as a safe, routine procedure. However, if a uterine fibroid is harboring an undetectable cancer, the morcellation of that cancerous tissue and its removal through the abdominal cavity can spread that cancer throughout a woman’s body. This device can take a Stage 1 treatable cancer immediately to a Stage 4 terminal cancer. And tragically for too many women, this routine procedure ended with a death sentence.
Although the risk of spreading unsuspected cancers in women is as high as 1 in 352 cases, for decades the device stayed on the market, and it was only in November 2014 that the FDA put a black box warning on the device. It took a victim of morcellation and mother of 6, Dr. Amy Reed, to get the FDA take notice. It took the families of those who lost mothers, sisters, and wives, and those who continue to battle the cancer spread by morcellation, to get the FDA to take action.
As part of the Cancer Moonshot, we have the chance to protect others from the harm caused by dangerous medical devices. In 2016 there will be an estimated 595,690 cancer deaths in the United States. We must guard against unsafe medical devices from contributing to those staggering statistics. While supporting the development of new devices to target cancer, we must ensure that the FDA is able to review, monitor, and quickly take action should those devices do harm.
Unfortunately, we are too late for many women who, because of morcellation, were not given a fair chance to fight and beat their cancer. But we have a chance to protect others. We must take action.
There are simple steps we can take today to improve patient safety for tomorrow’s beneficiaries of innovative new devices. One simple way we can do this is to ensure that serious injuries and deaths caused by medical devices are promptly reported to the FDA. For years there was evidence that morcellation was spreading cancer in women. But those reports never made it to the FDA. For years women were dying from the cancer spread by this device. But their deaths were never reported to the FDA by the hospitals, the device manufacturers, or the doctors who were charged with their care.
This was despite federal requirements that FDA be informed about unsafe devices. We must do more to strengthen medical device reporting regulations to ensure that dangerous devices, like the morcellator that spread cancer in women for decades, are quickly identified and removed from the market before they can do more harm.
I applaud your leadership on this important mission that will undoubtedly save lives, and look forward to continuing to work with you to help eliminate cancer as we know it.
Please do not hesitate to contact me if I may be of assistance.
Sincerely,
Mike Fitzpatrick
Member of Congress
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Morcellation
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