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Morcellation Media Monitoring 08/20/2015
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Cautious politicking or equivocal lawmaking: Senator Robert Casey Jr. on medical device safety
Aug 18, 2015 | The Philadelphia Inquirer
By Hooman Noorchashm, M.D., Ph.D. and Amy J. Reed, M.D., Ph.D.
On November 15, 2011 the United States Senate’s committee on Health, education, Labor and Pensions (HELP), heard a testimony from a special committee of the Institute of Medicine (IOM). The committee had been formed to review the primary legal mechanism used by the Food and Drug Administration (FDA) to clear medical devices for marketing – this process is known as 510(k). -
Morcellators Risk of Spreading Cancer Under Continued Investigation by FBI
Aug 19, 2015 | Kuam News
By Press Advantage
Tracey & Fox first reported on May 28th, 2015 that the Federal Bureau of Investigation was looking into allegations against Johnson & Johnson regarding one of the surgical tools it manufactured, the power morcellator. The FBI is concerned that Johnson & Johnson were aware of the heightened risks of spreading uterine cancer when the tool was used in laparoscopic surgeries, prior to 2014. That investigation continues today. -
Congress Members Call for Power Morcellators Investigation
Aug 19, 2015 | Top Class Actions
By Paul Tassin
A dozen members of congress are calling for an investigation into why the FDA took so long to warn about the risk of cancer associated with the use of power morcellators. The request comes from a bipartisan group of 12 representatives led by Rep. Mike Fitzpatrick of Pennsylvania. They are asking the Government Accountability Office to investigate why the FDA allowed marketing of power morcellators without a warning for over 20 years. They note that hundreds and possibly thousands of women have died from morcellator cancer.
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Cautious politicking or equivocal lawmaking: Senator Robert Casey Jr. on medical device safety
Aug 18, 2015 | The Philadelphia Inquirer
By Hooman Noorchashm, M.D., Ph.D. and Amy J. Reed, M.D., Ph.D.
On November 15, 2011 the United States Senate’s committee on Health, education, Labor and Pensions (HELP), heard a testimony from a special committee of the Institute of Medicine (IOM). The committee had been formed to review the primary legal mechanism used by the Food and Drug Administration (FDA) to clear medical devices for marketing – this process is known as 510(k).
In this testimony the IOM committee chairman clearly stated that the: “510(k) process is not intended to evaluate the safety and effectiveness of medical devices with some exceptions. Furthermore, the 510(k) process cannot be transformed into a premarket evaluation of safety and effectiveness”.
In other words, the federal legislation governing medical devices in the United States is not designed to ensure patient safety and public health. The implication of this conclusion is that 510(k) poses a serious threat to people’s safety.
Who in congress heard about this and why has nothing been done?
Pennsylvania’s senator, Robert Casey Jr., is a senior member of the senate HELP committee, responsible for FDA oversight. He was present for, at least, a portion of the 2011 hearing. But according to the video record, he seems to have missed the IOM chairman’s presentation that day.
However, even if absent, senator Casey must have been briefed by his legislative assistants about this important IOM study and its public health implications – all senators are briefed on such key hearings.
That day, the senator politely asked a few questions unrelated to patient safety. You may view Casey’s comments in this video from 50:20 to 56:58.
Despite specific examples of safety failures provided and the IOM’s expert analysis, the United States senate HELP committee did nothing concrete to revise or replace this legislation – certainly senator Casey, remained silent on this very clear safety warning.
But in December of 2013, another severe example of a devastating medical device failure emerged into the public eye as a result of our family’s tragedy.
We strongly believe that this tragedy was in great part the result of the 2011 senate HELP committee being more concerned about FDA streamlining and “speed of clearance” than to patient safety and public health.
Nonetheless, we also felt that given his intimate knowledge of the 2011 IOM report on medical device safety, senator Casey would understand the urgent need for correcting the medical device safety failure – especially, given the scale of the women’s health disaster we had brought to him.
So in January 2015, we met with the senator’s legislative staff – he, himself, was unavailable for this meeting.
After our meeting, Senator Casey and his staff wrote a letter with a series of questions about the power morcellator to then FDA commissioner, Margaret Hamburg.
He also wrote a letter to the president of the health insurance advocacy group, AHIP posing a few other questions.
We do not know if, to date, the FDA commissioner responded to the senator’s letter. But in April 2015, the AHIP president responded to the Casey letter.
The AHIP letter to Casey states: “the experience with power morcellators also shines a spotlight on gaps in the device safety infrastructure and the critical need to strengthen the pre- and post-market review and approval process.”
In other words, for a second time in the span of five years, senator Casey has heard about and pondered the severe hazard to patient safety and public health posed by inadequate federal regulation of medical devices by FDA.
But despite our vocal requests, as the senator’s constituents, to directly call for a serious and immediate congressional hearing to reform the medical device safety legislation – we heard nothing more.
When asked by a reporter about the safety failure in 510(k), senator Casey stated that there were no plans to bring the legislation up again anytime soon. Worse yet, in this interview, he seemed more concerned about the efficiency of getting medical devices to market – he said nothing about patient safety or women’s health.
Whether Casey’s orientation on medical device regulation is cautious politicking or equivocal lawmaking, remains unclear to us. But what we know with certainty is that senator Casey is fully aware of a serious and deadly safety deficit in the medical device regulatory space.
Letter writing and formal queries by a lawmaker are fine expressions of concern and may even serve to catalyze some action. But, for the most part such letters appear to be gestures used to placate concerned constituents, while providing good defense against future political criticism.
But when deadly threats to the health of American families become evident, neither cautious politicking nor equivocal lawmaking can be accepted from our elected representatives in federal office.
When lives are being put in harm’s way EVERY DAY because of a deficiency in federal legislation, letters sent and queries filed are not sufficient. As an elected federal official, you can not stop at “I am not certain when this will be addressed”. -
Morcellators Risk of Spreading Cancer Under Continued Investigation by FBI
Aug 19, 2015 | Kuam News
By Press Advantage
August 19, 2015 – /PressAdvantage/ – Tracey & Fox first reported on May 28th, 2015 that the Federal Bureau of Investigation was looking into allegations against Johnson & Johnson regarding one of the surgical tools it manufactured, the power morcellator. The FBI is concerned that Johnson & Johnson were aware of the heightened risks of spreading uterine cancer when the tool was used in laparoscopic surgeries, prior to 2014. That investigation continues today.
The power morcellator is a tool often used by doctors in hysterectomies or myomectomies. A hysterectomy is performed to remove the uterus, and a myomectomy is performed to remove fibroids from the uterus. The morcellator became popular very quickly after its initial release, due to its ability to provide doctors with a minimally invasive way to remove unwanted tissue from the uterus. During laparoscopic procedures the morcellator is inserted in the abdominal cavity where it cuts the unwanted tissue into smaller pieces that then can be removed. However, the public was unaware that there were risk factors associated with the use of the morcellator.
The FDA initially released a Safety Communication regarding the use of morcellators in April 2014, which it later updated on November 24th, 2014. That communication states that “Based on an FDA analysis of currently available data, we estimate that approximately 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma.” This is dangerous to women in whom the cancer remains undetected, because as the morcellator cuts the unwanted tissue in the uterus, it also can move cells to previously untouched areas of the abdomen – a similar effect to sawdust coating the area around where wood is sawed. If a women has undiagnosed sarcoma, it is possible that the use of a morcellator can spread that cancer to other areas of the body.
Johnson & Johnson withdrew all sales of the morcellator and began to advise doctors against the use of the tool in April 2014. However the FBI is investigating disturbing allegations that Johnson & Johnson had been aware of the increased risks as early as 2006, prior to the FDA report.
Despite the FDA placing a “black box warning” on the power morcellator, manufacturers other than Johnson & Johnson continue to sell their products in the United States. There have been an increasing number oflawsuits against the manufacturers of morcellators by women who are alleging the tool caused their undiagnosed uterine cancer to be spread to other parts of the body. Women who are scheduled to undergo either a hysterectomy or myomectomy should consult with their doctor regarding how the procedure will be performed.
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Congress Members Call for Power Morcellators Investigation
Aug 19, 2015 | Top Class Actions
By Paul Tassin
A dozen members of congress are calling for an investigation into why the FDA took so long to warn about the risk of cancer associated with the use of power morcellators.
The request comes from a bipartisan group of 12 representatives led by Rep. Mike Fitzpatrick of Pennsylvania. They are asking the Government Accountability Office to investigate why the FDA allowed marketing of power morcellators without a warning for over 20 years. They note that hundreds and possibly thousands of women have died from morcellator cancer.
A power morcellator is a device used in laparoscopic surgery to shred and remove tissue. It can be used in hysterectomy or uterine fibroid surgery to remove tissue through the smaller incisions used in laparoscopic surgery. These devices have been on the market since they were first approved by the FDA in 1991.
By shredding tissue inside the abdomen, a power morcellator can cut up previously undetected, or “occult,” cancerous tissue and distribute it elsewhere in the body, potentially causing the cancer to spread and advance rapidly.
The FDA issued a warning in April 2014 recommending that surgeons stop using power morcellators in certain patients. The FDA has since added a warning to the products’ labeling. The agency cited studies estimating that as many as one in 350 of women undergoing these procedures has an undetected cancer putting them at risk for morcellator cancer.
The congressional request asks the GAO to determine whether manufacturers followed the FDA’s adverse event reporting requirements, what training manufacturers provided to physicians, and what action the FDA is taking to determine whether to take power morcellators off the market.
A spokesperson from the GAO said the agency will evaluate the request and determine whether to conduct an investigation.
The effort to get congressional action on morcellator cancer has been driven in large part by Dr. Amy Reed, an anesthesiologist who suffered an upstaging of an occult cancer after a 2013 laparoscopic uterine fibroid surgery, and her husband Dr. Hoorman Noorchashm, a surgeon.
Dr. Reed underwent six courses of chemotherapy and other treatment. Her cancer has recurred twice, in February and June of this year. The couple and their family have recently moved to Philadelphia so that Dr. Reed can continue treatment.
Drs. Reed and Noorchashm have since been lobbying Congress for a ban on power morcellators. They are also campaigning to reform the FDA’s expedited process for device approval known as the 510(k) process. Under 510(k), manufacturers can get quick approval for a new device if that device is substantially similar to another device already on the market. The process allows the manufacturer to skip premarket safety testing and to avoid postmarket monitoring.
The growing body of information about morcellator cancer has led to a significant reduction in the use of those devices. Hospitals, insurance companies, and individual physicians have voluntarily restricted their use of power morcellators. Johnson & Johnson has stopped marketing its own power morcellators.
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