Monsanto toxic chemicals, FDA corruption, 1994 and 2017

1994:   Senator Bernie Sanders

F.B.I. Investigates: Are Medical Device Adverse Events Reported?

F.B.I. Investigates Whether Harm From Surgical Power Tool Was Ignored

By DENISE GRADY and KATIE THOMAS MAY 27, 2015

The Federal Bureau of Investigation has begun looking into whether medical device makers, doctors and hospitals broke the law by failing to report problems linked to a power tool used during gynecologic surgery, according to two people who said they were interviewed by investigators.

The tool, called a morcellator, has rapidly spinning blades that cut tissue into pieces that can be removed from the body through the tiny slits made during minimally invasive surgery. Morcellators have often been used in surgery to remove the uterus, but in some women with undetected cancers they have sprayed malignant cells around inside the abdomen like seeds, speeding the progression of the disease.

The inquiries were first reported on Wednesday by The Wall Street Journal, which said the agents worked out of the F.B.I. office in Newark, N.J.

Celeste Danzi, a spokeswoman for the F.B.I.’s Newark office, declined to confirm the inquiry. “We just don’t comment on the existence or nonexistence of any investigation,” she said.

In an interview with The New York Times, Dr. Hooman Noorchashm, whose wife, Dr. Amy Reed, was harmed by the device, confirmed that they had spoken a number of times to an F.B.I. agent from Newark. A retired pathologist from Pennsylvania, Dr. Robert W. Lamparter, also said he had spoken to investigators. Both men declined to name the agent, saying they had been warned that disclosing too much information could interfere with the investigation.

Dr. Reed, 42, an anesthesiologist, had a hysterectomy because of fibroid tumors in her uterus in October 2013 at Brigham and Women’s Hospital in Boston. Fibroids are benign, but they sometimes hide cancer. A biopsy after Dr. Reed’s surgery found a hidden sarcoma, an aggressive type of cancer. The tumor spread, resulting in advanced Stage 4 cancer. Dr. Reed underwent numerous rounds of chemotherapy and radical surgery, but the cancer recurred in March of this year, near her spine, requiring still more surgery.

The couple, who have six children, have conducted a ceaseless nationwide campaign to ban morcellation. Gynecology groups have resisted, saying that sarcomas are uncommon and that morcellation makes surgery less invasive and safer for the majority of women.

In November, the Food and Drug Administration said that morcellators should no longer be used in “the vast majority” of women. But the agency did not take the devices off the market or ban their use.

Dr. Noorchashm said he contacted an agent from the Newark F.B.I. office last fall, because he suspected that morcellator manufacturers and some doctors and hospitals using the devices had violated a federal law requiring that adverse events be reported to the F.D.A. He said that he and his wife spoke with the agent a number of times over a few months, and that the F.B.I. seemed increasingly interested.

Dr. Lamparter said that he had also recently spoken to the F.B.I., and that the conversation had focused on his 2006 correspondence with Ethicon, the unit of Johnson & Johnson that sold power morcellators. At that time, he warned Ethicon of the potential for the morcellators to spread undetected cancer, according to email correspondence he provided to The Times and other news outlets. Johnson & Johnson withdrew its morcellators from the market last July.

Johnson & Johnson has said that after Dr. Lamparter raised his concerns, it added new language to the instructions for use of the device, and that the company had already recommended that, in patients where a cancer was suspected, doctors should use a special bag to remove the tissue.

In a telephone interview Wednesday, Dr. Lamparter said that he considered the change a “legal fig leaf” and that the gynecologists at his hospital, Evangelical Community Hospital in Lewisburg, Penn., reported that the training they received from the company in using the device did not substantially change after he raised his alarm.

Dr. Lamparter said he initially believed that the morcellator could still be used, but not on women at high risk for cancer. However, he added, “I’ve come to believe that the morcellator, as it is used now, is just a bad idea.”

Ernie Knewitz, a Johnson & Johnson spokesman, said it was unaware of any investigation.

Kate Zernike contributed reporting.

http://www.nytimes.com/2015/05/28/business/fbi-investigates-whether-harm-from-surgical-power-tool-was-ignored.html?emc=edit_tnt_20150527&nlid=50639700&tntemail0=y&_r=0

Update: Sign this petition to ban uterine morcellation device.

FiDA UPDATE:
http://www.cancerletter.com/articles/20141126_1?utm_content=buffera6f9c&utm_medium=social&utm_source=twitter.com&utm_campaign=buffer

Urgent FDA Action Turns Power Morcellation Into Rarely Used Gynecological Procedure

A Karl Storz power morcellator, one of the devices that will be affected by FDA's latest guidance. This model was used in a Brigham & Women's Hospital study testing the ability of containment bags to reduce the risk of cancer dissemination. That study has been halted.

By Matthew Bin Han Ong  

The power morcellator should no longer be used for hysterectomies or fibroid removal in the vast majority of women getting these procedures, FDA declared in a highly anticipated guidance document Nov. 24.

Using a new authority that bypasses public comment, the agency stopped short of imposing an outright ban on the device, but severely restricted its use in the following manner:

• The agency placed a “black box” label on the device, warning that the use of power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients. The boxed warning is FDA’s sternest warning for significant risk of serious or life-threatening adverse effects.

• The agency’s guidance decreed that power morcellators are contraindicated for removal of uterine tissue in menopausal and post-menopausal women, and in women who are eligible for surgeries that remove uterine tissue intact i.e. through the vagina or mini-laparotor.

• Similarly, power morcellators are now contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected to be cancerous.

Categorized as a Class II moderate-risk surgical device by FDA, the power morcellator is used to cut tissue into small fragments for removal through small incisions. When used in patients with undetected or missed uterine cancers, the device spreads malignant tissue in the patient’s abdominal cavity, rapidly upstaging the disease (The Cancer Letter, July 4).

FDA’s move is expected to adversely impact minimally invasive surgical gynecologists, who made power morcellation a routine procedure, which is performed in a subset of an estimated 50,000 to 100,000 women who undergo laparoscopic procedures for hysterectomy each year in the United States.

Class II devices are cleared through the 510(k) process, which applies to new devices that are based on comparability to predicate devices already in use. Only Class III high-risk devices require an FDA premarket approval application.

Here, semantics mean a lot: the standards for Class II clearance aren’t as rigorous as for Class III approval.

This week’s FDA guidance does not reclassify the power morcellators. It is unclear whether FDA intends to re-categorize power morcellators or require manufacturers to resubmit the devices for approval as Class III devices.

In its decision, the agency cited its earlier estimate that one in 350 women who are undergoing hysterectomy or myomectomy for fibroids is found to have an unsuspected uterine sarcoma. The American Association of Gynecologic Laparoscopists disagrees with the estimate, citing international data reporting lower prevalence rates.

“The FDA decision today is based on what we believe is best for patients,” William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, said at a press call Nov. 24. “The contraindications cover the vast majority of women who would undergo morcellation during myomectomy or hysterectomy, which should reduce the use of the device in patients at greatest risk.”

The contraindications are so broad that they make morcellation appropriate only for young women who may choose, after a consent process, to undergo the minimally invasive procedure to preserve their ability to bear children.

The agency’s decision comes nearly a year after former Harvard physicians Amy Reed and Hooman Noorchashm launched a vigorous campaign that drew FDA’s attention to the issue (The Cancer Letter, July 4).

“I think it’s a good first step, or second step after the April advisory,” said Rick Kaitz, a Boston attorney whose wife, Erica, died after her leiomyosarcoma was upstaged by power morcellation performed at Brigham & Women’s Hospital, a Harvard-affiliated institution (The Cancer Letter, Nov. 21).

“In most circumstances, I can’t imagine that this industry is going to continue to survive at the moment. I think FDA’s decision is strong enough to significantly impact the nature of the practice,” Kaitz said.

“Drs. Reed and Noorchashm should be really saluted for the amount of progress they’ve made within a relatively short period of time. I know for all of us it seems like forever, but I’m very encouraged.”

Immediately in Effect

This is the first time FDA has used an authority, called the “Immediately In Effect” guidance.

According to Maisel, the IIE was created by CDRH to act swiftly on issues that the agency would normally respond to with a routine guidance.

“We didn’t feel that issuing this guidance in draft form, and waiting for a comment period, and then finalizing it, is in the best interests of the public health,” Maisel said at the press call.

Bill Vodra, a former FDA associate chief counsel for drugs, said the agency’s rapid response is extraordinary.

“The timeframe of this is pretty astoundingly fast, for me at least,” Vodra said to The Cancer Letter. “If you get people who understand the system i.e. doctors who become patients, they can push much more aggressively than the ordinary consumer can. What I’m most impressed by here is how quickly they’ve done this.”

Vodra helped draft many agency regulations still in use, including those implementing the Controlled Substances Act and FDA’s rules for Good Manufacturing Practices, Good Laboratory Practices, Good Clinical Practices, bioequivalency and the Orange Book.

“Compare how long it took FDA to address this issue, with, let’s say, the surgical mesh that was being used a couple of years ago—that took years for FDA to finally get around to do something about it,” Vodra said.

The American College of Obstetricians and Gynecologists, a 58,000-member professional society, said it would seek additional clarification of the agency’s guidance.

“We are pleased that the FDA’s action takes steps to enhance patient safety while allowing the appropriate use of power morcellation in gynecologic surgery for select women,” Hal Lawrence, executive vice president and CEO of ACOG, said in a statement. “The FDA’s clarification of contraindications for morcellation will help to ensure that only women at low risk for an occult malignancy will undergo laparoscopic hysterectomy or myomectomy with morcellation.

“However, we look forward to working with the FDA to provide additional clarification regarding certain language within the contraindications that could be confusing to patients and physicians.”

AAGL, another professional society, characterized FDA’s action as a setback.

“Abandoning power morcellation technology for many patients undergoing minimally invasive myomectomy, supracervical hysterectomy, or hysterectomy for a large uterus will be a setback in the care of patients with gynecologic conditions,” Franklin Loffer, AAGL medical director, said in a statement.

Observers: FDA “Severely Restricts” Device Use

FDA-watchers said the agency’s decision would likely eliminate power morcellation as a routine surgical procedure in gynecology.

“FDA’s statement is going to discourage a significant amount of use, assuming that most of these procedures are being done in post-menopausal and menopausal women. That’s a pretty clear statement. They want this to drop substantially,” said Vodra, a retired partner of Washington, D.C., law firm Arnold and Porter. “If 80 percent of the women who undergo power morcellation are peri- or post-menopausal, then 80 percent of these procedures shouldn’t be done anymore.”

“The contraindication means no rational person would use the product this way. So that’s really saying, ‘No doctor out there should use this. If a doctor goes ahead and uses it, it’s not malpractice per se, but, in many or some jurisdictions, it shifts the burden of proof from the patient to the doctor.’”

Normally, in a medical malpractice case, the patient has to show that the doctor did not follow the standards prevailing in his or her community at the time that a procedure was done or a drug was used.

“Now, any physician that continues using power morcellators, and any device company which still wishes to sell and promote these devices will be taking a huge risk in the liability arena, both medical and otherwise,” said David Challoner, emeritus vice president for health affairs at the University of Florida. “It’s de facto, not de jure.”

Challoner chaired the Institute of Medicine committee tasked by FDA and Congress in 2009 to review the 510(k) process that clears Class II devices such as the power morcellator based on predicate devices.

“I see FDA’s action as severely restricting the use of morcellation in the treatment of uterine fibroids,” Challoner said. “That’s a very desirable outcome, and it’s only slightly second-best to just banning the instruments from the market completely.”

More insurance companies may refuse to pay for power morcellation as a result of FDA’s guidance. Several companies have ended payments for the procedure prior to the guidance (The Cancer Letter, Nov. 21).

“It would be up to the insurance company and the laws governing insurance,” Vodra said. “Clearly, they could refuse to pay for any procedure that is contraindicated. But normally, a boxed warning would not be disqualifying from reimbursement.”

FDA said it would continue to consider other steps that may further reduce the risk of spreading unsuspected cancer, including preoperative cancer detection methods, or containment devices, such as bags, that can prevent dissemination of malignant tissue.

The Brigham & Women’s Hospital has halted a controversial study that combined power morcellators with “containment bags” intended to capture tissue during gynecological surgery.

Key Advocates Call for Ban

Reed and Noorchashm, the couple who led the campaign against morcellation, called FDA’s decision a “failure.”

“This is a massive and monumental failure in federal regulation,” Noorchashm said to The Cancer Letter. “From a scientific, clinical, surgical and common sense perspective, it’s very clear that you don’t mince up tissues that have any degree of malignant potential inside a patient’s body.

“The FDA was confronted with this problem. They chose to not definitively regulate this problem, and that is clear demonstration of regulatory incapacity. They were given a binary decision to make and they failed. This should tell anyone with a remote understanding of the issue that the FDA is a captured agency—beholden to industry interests over patient safety.”

Reed said banning the device is the only appropriate action.

“People say we should be thankful that we’ve gotten as far as we have, that it moved as it did and we raised the level of awareness,” Reed said. “But I have to say, overall, I’m overwhelmingly disappointed with the whole decision. There is no question in my mind that they should have outright banned it, and I’m not sure what they thought they were overreaching if they did.”

FDA’s Maisel said that banning power morcellators would require doctors and patients to choose other options—typically more invasive surgery.

“Banning laparoscopic power morcellators would completely remove them from the market for all patients in all indications,” Maisel said. “We recognize that there are risks associated with all fibroid treatment options, and we believe there is a very small population in whom the benefits for this procedure.

“When the patients are appropriately informed of the potential risks, and that the potential benefits may outweigh the risks, the individual women may choose to have their procedure done, knowing the potential benefits and risks.”

Maisel said the key to preserving fertility in some women is to minimize the damage to the uterus.

“We recognize that some younger women who are interested in maintaining their ability to have children or wish to keep their uterus intact after being informed of the risk, may be candidates for this procedure,” Maisel said at the press call. “Younger women present a lower risk of having underlying cancer than older women.

“Doctors and patients should determine if the patient is in an appropriate patient, together, and the agency believes that women should have this option available to them should they wish to preserve their fertility and they are informed of the risk.

“Being able to remove the fibroid and reduce the risk of adhesions that might be associated with a traumatic surgery can help preserve fertility,” Maisel said. “Some clinicians specialize in this area, and believe that it is an important tool that needs to remain available.”

Reed and Noorchashm disagree.

Reed said no data exist to show that fertility is adversely affected in laparotomies vs. laparoscopic removal of fibroids with power morcellation.

“Firstly, I would like to see the data that mini-laparotomy versus full laparoscopy for fibroids has a detrimental impact on fertility,” said Reed, formerly an anesthesiologist at Beth Israel Deaconess Medical Center. “That’s what they are saying, that adhesions by mini-laparotomy would negatively impact the fertility of women, so they should be allowed to opt for it. I know of no data that supports that claim.”

“For such a data heavy driven argument I want to know who said that this was a problem and based on what? Because the adhesions caused by spraying a huge fibroid around likely are as significant as a laparoscopic dissection and mini-laparotomy.”

“And I think that is the important point: it’s power morcellation vs. laparoscopic dissection and mini-laparotomy, not full laparotomy.”

Reed underwent power morcellation at Brigham & Women’s Hospital in October 2013. The procedure upstaged her previously undiagnosed leiomyosarcoma, which was then aggressively treated. The disease is now in remission.

“Because of the wording of the FDA, women will still be on that table having power morcellators used at the discretion of the physician,” Reed said to The Cancer Letter. “Secondly, I would like the FDA to clarify what its intentions are in regards to studying containment devices. Knowing the potential for harm is great, is this something they intend to support human experimentation on? They clearly state that this is an area that they will watch closely. Will this be done in animals, or will they permit this to be done in humans? Surely one would think not.

“I think the FDA has some serious explaining to do.”

Noorchashm said that alternative uterus-sparing surgeries are available.

“You don’t need to use a morcellator to do a myomectomy, which is what is meant by a ‘uterine sparing’ operation. Morcellators are only used to extract the tissue from small incisions,” said Noorchashm, a cardiothoracic surgeon who formerly practiced at Brigham and who is now at Thomas Jefferson University. “To perform a uterine sparing operation, these surgeons can dissect out the problematic myomas they’ve ascertained are not malignant using intra-op or pre-op biopsies. Then, they take out the bagged myomas through a small incision. It’s really that simple. There is absolutely no need to use a morcellator.”

“You can, perfectly well, either by using laparoscopic or robotic devices, do a myomectomy and remove the myoma from the body without power morcellation through a small incision at the end of the operation. I think the concept that a uterine sparing myomectomy requires a morcellator is a smokescreen created by device advocates and gynecologists—it’s hogwash.”

Several members at an FDA advisory committee hearing in July expressed a desire to avoid any kind of morcellation of tissues (The Cancer Letter, July 25).

“Myomectomy, in and of itself, isn’t an oncologically safe procedure. There is a conundrum there,” Reed said. “But you don’t have to make it worse by spreading everything all over the abdominal cavity with power morcellation.”

Vodra: 510(k) Does Not Necessarily Protect Consumers

Pre-menopausal young women who elect to undergo power morcellation could be waiving the ability to claim medical malpractice against their physicians, if they are harmed by the surgery.

“If a woman is pre-menopausal and elects to undergo power morcellation, then if she has been warned by the doctor that these are the risks and benefits, and she then chooses the procedure, she probably has no claim whatsoever against the doctor,” Vodra said. “When a doctor uses the normal standard of care, in which you’d advise a patient before a surgery on what the risks are, the patient can opt to have it or not have it.”

However, doctors can be vulnerable in these situations if they fail to exercise due diligence.

“I could see situations in which, for example, the doctor did not do any medical history to determine whether the patient was at risk of uterine cancer, and did nothing to check or test whether this patient could have a cancer,” Vodra said.

“If there is a blood test available at some point and he didn’t run the blood test before he did the procedure, that could lead to malpractice.

“The doctor cannot say, ‘What do you want me to do?’ The patient’s not an expert, the doc is, and has an obligation to exercise due diligence according tothe standard of care in the community before surgery is done.”

Young women should not be subject to the risks of power morcellation when there are alternatives, Reed said.

“I had some degree of health literacy, but what do you do with somebody with a third grade education? What do you with somebody with prejudices against the medical establishment, and there are issues with fertility and management?” Reed said. “There are entire subsets of population who look at all this very differently than Hooman and I do.

“There are a lot of women who’d say, ‘I don’t want you to be taking my fertility away,’ even if they have no intention of having children. That’s a touchy subject, but again, you can do without morcellation.

“FDA is very quick to trash drugs that do not meet safety and efficacy criteria, but on the other hand, here’s a dangerous device, and it’s not banned. What’s the hold up?”

Vodra said the premarket requirements for drugs, and for Class II devices such as the power morcellator are very different.

“In the drug arena, drugs have to be shown to be safe and effective for a specific use in order to get them into the marketplace,” Vodra said. “In the device arena, you don’t have to.

“The 510(k) process means you simply have to show that you’re substantially equivalent to another device that’s in the marketplace. You don’t have to show that you’re effective at doing anything, and in a lot of products—like the scalpel—you don’t need to.

“If I read the history of the power morcellator right, it was cleared for one purpose, and doctors started using it for a different purpose, so that’s where the problem arose.

“That’s where drugs and devices differ. Almost all drugs have to be shown to be effective for a specific use before they can get to the market for any use, whereas devices don’t have to do that.

“That’s what the 2011 IOM report on the 510(k) is about. The 510(k) is not protecting the consumer in the way people think it is.

“People thought that the devices that were cleared are safe, but they are not approved. FDA approves products that are safe and effective, but it clears devices that can prove to be equivalent to something else.”

Copyright (c) 2014 The Cancer Letter Inc.

 http://petitions.moveon.org/sign/campaign-against-morcellatio.fb49?source=s.fb&r_by=10266987

PLEASE SIGN THIS PETITION AND SHARE !!

courtesy of American Recall Center

Dr. Hooman Noorchashm has spearheaded this effort because his wife, Dr. Amy Reed is one of the victims of this FAILED and essentially unregulated device that spreads and upgrades undetectable cancerous tissue in the uterus.  There are other alternatives for hysterectomy that do not expose women to this PREVENTABLE catastrophic and irreversible danger.  

Other references:

http://www.democratandchronicle.com/story/all-about-health/2014/07/11/couple-put-real-people-into-fda-hearing/12517557/

http://www.fda.gov/advisorycommittees/calendar/ucm400221.htm

http://www.recallcenter.com/power-morcellator/lawsuit/

https://www.facebook.com/pages/American-Recall-Center/576580039088552

http://online.wsj.com/articles/doctor-quits-uterine-device-safety-panel-over-conflict-1405013226

http://newbrunswicktoday.com/article/jj-paid-over-150k-doctor-who-sat-fda-safety-panels#.U_vVyL4bhzw.facebook

http://www.prevention.com/health/health-concerns/morcellation-surgery-when-cutting-edge-kills?cid=social_20140603_25180366&cm_mmc=Twitter-_-Prevention-_-health-healthconcerns-_-morcellationsurgery

http://boston.cbslocal.com/2014/04/25/local-couple-makes-push-to-ban-morcellation/

http://www.usatoday.com/story/news/nation/2014/02/18/hysterectomy-laparoscopic-morcellation-amy-reed/5347093/

http://www.medscape.com/viewarticle/829476

http://blogs.wsj.com/corporate-intelligence/2014/09/23/jjs-exit-from-morcellator-sales-leaves-opportunities-for-others/

J&J $100,000 conflicted FDA panel member on morcellator device?

	JjrkCh #morcellator First speaker at #fda Advisory today defended #surgical mesh at Batiste trial in Dallas: http://t.co/L3HoWtjxeO 7/10/14, 8:06 AM
	JjrkCh #morcellator #fda More on Piet Hinoul at Batiste surgical mesh trial. http://t.co/AklVXmrvfx 7/10/14, 8:09 AM

http://online.wsj.com/articles/doctor-quits-uterine-device-safety-panel-over-conflict-1405013226

U.S. NEWS

Doctor Quits Uterine-Device Safety Panel Over Conflict

Move Comes Before Hearing on Cancer Risk From Morcellation Procedure

By JENNIFER LEVITZ And JON KAMP CONNECT

Updated July 10, 2014 3:25 p.m. ET

SILVER SPRING, Md.—A member of an independent panel weighing the safety of a medical device that can spread cancer in women stepped down after the U.S. Food and Drug Administration reviewed consulting fees he had accepted from a device manufacturer, the agency said Thursday.

San Francisco gynecologist Andrew Brill removed himself from the 16-member panel before two days of hearings on the device were set to begin Thursday, an FDA spokesman said. Dr. Brill didn't respond to requests for comment.

In 2013, he received nearly $100,000 in consulting fees from Ethicon, a Johnson & Johnson JNJ -0.08% subsidiary that is by far the largest manufacturer of a tool known as a laparoscopic power morcellator. The advisory panel is expected to make a recommendation to the FDA about whether morcellators, used in an estimated 50,000 hysterectomies a year, should be more tightly regulated or even used at all.

"The FDA has a rigorous conflict of interest process in place designed to ensure the integrity of our meetings. During the course of the agency's review and in consultation with Dr. Andrew Brill, it was determined that the financial information he disclosed was just above the threshold established for panel members to participate in one of our meetings," an FDA spokesman said.

The Wall Street Journal first asked the FDA and Dr. Brill about the consulting fees on Tuesday after comparing publicly released names of the members of the panel with a list of paid consultants on J&J's website and other public documents. The agency declined to speak until Thursday morning.

J&J, the only manufacturer that releases names of its paid consultants, said Dr. Brill has done professional education consulting for them in their women's health and energy businesses and that he is a recognized leader in the field.

At least two other gynecologists on the panel have had financial ties to manufacturers, according to J&J's website and other public documents. The FDA declined to release its own disclosure statements submitted by panel members, citing privacy laws for advisory-committee members.

Michael P. Diamond, a Georgia gynecologist and acting chairman of the FDA panel meeting on morcellators, was previously a consultant for Ethicon and received a grant from the company, he said Thursday in response to a question from the Journal. He declined to say the amount he received.

Keith Isaacson, a Boston gynecologist, received nearly $12,000 in consulting fees from Ethicon in 2013. His work for the company has been as a "professional-education consultant," a J&J spokesman said. A spokesman for Dr. Isaacson wasn't available for immediate comment.

Both doctors remain on the panel.

Laparoscopic power morcellators are used to cut up common uterine growths called fibroids, often in a hysterectomy, so they can be removed from the body through small incisions. But in some instances, the devices can spread a rare but dangerous cancer that masquerades as benign fibroids.

The risk had been known for years but was believed to be extremely small. In April, the FDA said the risk was higher than previously thought and discouraged doctors from using morcellators while it considered a more permanent position on the tools.

The hearing drew a crowd of patients, relatives, doctors and industry representatives.

"Because morcellation upstaged her cancer, Elizabeth never had a chance," Joanne Jacobson told the panel about her sister, who died from cancer in January 2013 following a morcellation procedure, according to her medical records.

JoAnn Trainer urged a ban on cutting tissue inside the body while speaking on behalf of her daughter Amy Reed, a Boston physician whose post-morcellation cancer case triggered alarm that led to this week's meeting. Dr. Reed, sitting in the audience with her family, plans to speak Friday.

The head of the influential American College of Obstetricians and Gynecologists argued that taking away morcellators will drive more women to elect open abdominal surgery, which carries its own risks, such as bleeding and infection. "It is unacceptable that in an effort to avoid one risk, we subject women to another," ACOG Chief Executive Hal C. Lawrence III told the panel.

J&J halted all sales shortly after the FDA advisory in April. Piet Hinoul, vice president of medical affairs at J&J subsidiary Ethicon and a gynecologist, told the panel the company stands by this decision until there is consensus in the medical community about how to mitigate the risk.

He also argued against tougher regulation, which the panel is expected to discuss Friday. Dr. Hinoul urged instead efforts to better identify women who could be more at risk of harboring cancer. The cancer can't be reliably detected before surgery.

Write to Jennifer Levitz at jennifer.levitz@wsj.com and Jon Kamp at jon.kamp@wsj.com

Submit your public comments about Morcellation Devices NOW! Here's how:

http://www.fda.gov/advisorycommittees/calendar/ucm400221.htm

July 10-11, 2014: Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement

Center	Date	Time	Location
CDRH	July 10-11, 2014	8:00 a.m. - 6:00 p.m.	FDA White Oak Campus 10903 New Hampshire Ave. Building 31 Conference Center, the Great Room (rm. 1503) Silver Spring, MD 20993-0002

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0736]

Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting


AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA).  The meeting will be open to the public.

Name of Committee:  Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee.

General Function of the Committee:  To provide advice and recommendations to the Agency on FDA's regulatory issues.

Date and Time:  The meeting will be held on July 10 and 11, 2014, from 8 a.m. to 6 p.m.

Location:  FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993-0002. Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at:  http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading "Resources for You," click on "Public Meetings at the FDA White Oak Campus."  Please note that visitors to the White Oak Campus must enter through Building 1.

Contact Person: Shanika Craig, Shanika.Craig@fda.hhs.gov, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD  20993, 301-796-6639, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area).  A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice.  Therefore, you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.

Agenda:  On July 10 and 11, 2014, the committee will discuss the safety of laparoscopic power morcellator devices as it pertains to their potential to disseminate and upstage a confined, but undetected (occult) uterine malignancy during laparoscopic hysterectomy or myomectomy. FDA is convening this committee to seek expert scientific and clinical opinion on the risks and benefits of these types of devices when used for these procedures, based on available scientific data. The committee will make recommendations regarding the appropriate use, premarket testing, labeling, and other risk mitigations (including the use of containment bags) for these devices. 

On July 11, 2014, during the afternoon session, the committee will also be asked to discuss the regulatory classification of laparoscopic power morcellator devices when used to cut and extract tissue during gynecologic laparoscopic procedures and to assist FDA in determining the appropriate level of regulatory control necessary for this device type, including discussion of class II (special controls) or reclassification to class III (subject to premarket approval application (PMA)).

FDA intends to make background material available to the public no later than 2 business days before the meeting.  If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting.  Background material is available at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/default.htm. Scroll down to the appropriate advisory committee meeting link.

The Center for Devices and Radiological Health (CDRH) plans to provide a live webcast of the July 10 and 11, 2014, meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee.  While CDRH is working to make webcasts available to the public for all advisory committee meetings held at the White Oak campus, there are instances where the webcast transmission is not successful; staff will work to reestablish the transmission as soon as possible.  The link for the webcast is available at: https://colaboration.fda.gov/obgyd/, or further information regarding the webcast, including the Web address for the webcast, will be made available at least 2 days in advance of the meeting at the following Web site: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ObstetricsandGynecologyDevices/default.htm.  Select the link for 2014 Meeting Materials.

Procedure:  Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.  Written submissions may be made to the contact person on or before June 24, 2014. Oral presentations from the public will be scheduled between approximately 9 a.m. and 10 a.m. for both days of this meeting.  Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before June 16, 2014.  Time allotted for each presentation may be limited.  If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session.  The contact person will notify interested persons regarding their request to speak by June 19, 2014.

FDA will work with the manufacturers of laparoscopic morcellators and containment bags who wish to make presentations to ensure that adequate time, separate from the approximate time slots for the general open public hearing session, is provided.  Manufacturers interested in making formal presentations to the committee should notify the contact person on or before June 18, 2014.  Manufacturers with common interests are urged to coordinate their oral presentations.

FDA is opening a docket for public comment on this document.  The docket number is FDA-2014-N-0736.  The docket will close on August 11, 2014.  Interested persons are encouraged to use the docket to submit electronic or written comments regarding this meeting.  Submit electronic comments to http://www.regulations.gov.  Comments received on or before July 1, 2014, will be provided to the committee for their consideration. Comments received after July 1, 2014, will be taken into consideration by the Agency.

Submit written comments to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD  20852.  It is only necessary to send one set of comments.  Comments are to be identified with the docket number found in brackets in the heading of this document.  Received comments may be seen in the Divisions of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday and will be posted to the docket at http://www.regulations.gov. 

Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact AnnMarie Williams, at Annmarie.Williams@fda.hhs.gov, or 301-796-5966, at least 7 days in advance of the meeting.

FDA is committed to the orderly conduct of its advisory committee meetings.  Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

Dated: June 3, 2014.

Leslie Kux,

Assistant Commissioner for Policy.
 

Please Sign this Change.org Petition to Restrict Uterine Power Morcellation

PLEASE SIGN THIS PETITION TO BAN UTERINE POWER MORCELLATION

FDA hearing July 10 & 11 (deadline)

A Surgical Procedure’s Risks,Unmentioned

By JANE E. BRODY MARCH 17, 2014 12:01 AM

PERSONAL HEALTH

Jane Brody on health and aging.

Many patients assume that, like prescription drugs, surgical procedures and instruments undergo extensive testing and must be government-approved. It’s not necessarily so.

Developers, of course, do test new instruments, and practitioners often train with an expert before using them unsupervised to treat patients. And the Food and Drug Administration must confirm an instrument’s safety and effectiveness before it can be marketed — but only if the device is deemed significantly different from others already approved.

Surgical techniques, however, are not subject to the stringent approval process that drugs go through. And as with drugs, problems with new procedures may not become apparent until after they have been used many hundreds or thousands of times.

Such is the case with a popular treatment for a very common medical problem: uterine fibroids. The technique, called electric or power morcellation, has widespread appeal for both surgeons and patients. It is used during laparoscopic or robotic-assisted operations that are fast and effective, require only a tiny incision or none at all, and involve less pain, a shorter hospital stay and a quicker recovery. In most cases, these operations are safer than traditional surgery.

As recent reports have shown, however, power morcellation can also cause serious and sometimes life-threatening complications. Experts say that prospective patients are often not told about these risks before consenting to the operation.

The technique involves insertion of a tiny instrument with a rapidly rotating blade, the morcellator, that breaks up the fibroid so that it can be sucked out through the small opening of a laparoscope. But problems can arise months or years later if pieces of tissue escape into the pelvic cavity and seed themselves on other organs.

This problem is all the more serious if the fibroid that was morcellated happens to have contained a hidden cancer. Although the overwhelming majority of fibroids are benign, there is no certain way to tell before their removal if they harbor a cancer, which happens in 1 in 400 to 1 in 1,000 cases.

One such case involves a 41-year-old Bostonian, Dr. Amy J. Reed, an anesthesiologist and a mother of six, who now has a Stage 4 leiomyosarcoma after undergoing uterine morcellation. It is a rare but particularly aggressive uterine cancer. Dr. Reed and her husband, Dr. Hooman Noorchashm, a cardiothoracic surgeon, are waging a campaign through Change.org to halt use of the technique.

Despite several preoperative tests, neither Dr. Reed nor her surgeon suspected that cancer lurked within the fibroids that were removed. If she had had a traditional operation in which the fibroids were cut out or the entire uterus removed intact, it is highly unlikely that the cancer would have spread.

From 1983 through 2010, 13 unexpected uterine sarcomas were reported after uterine surgery on 5,666 patients. Among 1,192 women who underwent morcellation, two developed sarcoma that spread within the abdomen.

After reviewing the medical records of more than 1,000 women who received morcellation for fibroids, specialists at Brigham & Women’s Hospital in Boston found a ninefold higher rate of unexpected sarcoma than is now quoted to patients considering the procedure.

“These data suggest uterine morcellation carries a risk of disseminating unexpected malignancy with apparent associated risk of mortality much higher than appreciated currently,” the researchers wrote in the journal PLOS One in 2012.

Even benign uterine tissue, when it is spread to other parts of the abdomen during morcellation, can grow in places it doesn’t belong and cause pain, infection or bowel obstruction.

There is a technique that could make morcellation safer: encasing the tissue to be removed in a bag before it is broken up. But thus far, the procedure is infrequently used, and few surgeons are skilled in the technique.

Other established ways to treat bothersome fibroids are free of this potential risk, though complications like wound infection are possible.

Fibroids are extremely common, affecting half or more women during their reproductive years, when hormones foster their growth. They develop from the smooth muscle tissue of the uterus, ranging in size from tiny to huge, and often shrink after pregnancy and menopause.

Most women with fibroids are unaware they have them, but others can experience symptoms like prolonged heavy periods, bleeding between periods, pelvic pressure, constipation, frequent urination, backaches and anemia. They can sometimes cause infertility or miscarriage.

Fibroids are typically detected through a pelvic exam, sonogram or M.R.I., sometimes with saline solution or a dye used to better define their size and location.

Nothing needs to be done about a fibroid that causes no distress. Large, bothersome fibroids can often be shrunk by several months of treatment with medications that block estrogen and progesterone, causing temporary menopause and its attendant symptoms.

The drug mifepristone (RU-486) also can shrink fibroids, and Evista may do likewise, but only in postmenopausal women. Sometimes a low-dose oral contraceptive is used to reduce bleeding caused by fibroids without shrinking their size.

Noninvasive ultrasound surgery under M.R.I. guidance can be used to heat and destroy a fibroid without damaging the uterus. A fibroid also can be destroyed by injecting small particles into uterine arteries to cut off its blood supply.

Fibroids can be removed laparoscopically or robotically without damaging the uterus. If the fibroid is contained within the uterus, it can often be removed with surgical instruments inserted through the vagina and cervix. Some fibroids may be destroyed by applying heat or electric current to the uterine lining.

Very large, multiple or deep fibroids may require more traditional surgery, called an abdominal myomectomy, that spares the uterus, or with a hysterectomy, a more serious operation involving removal of the entire uterus, ending a woman’s menstrual periods and ability to bear children.

If you are contemplating treatment for symptomatic fibroids, your doctor should answer several important questions before you choose a method:

What is the nature of the problem, and how necessary is it to treat it?

What procedures are known to be effective, and what are the risks and benefits of each?

What is the approach you recommend, and how much experience do you have with it?

What are its possible complications, and how often do they occur?

Without a clear understanding of treatment options, their potential hazards as well as their effectiveness, it is not possible to for you to give informed consent.

http://en.wikipedia.org/wiki/Morcellator

Morcellator

From Wikipedia, the free encyclopedia

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A morcellator is a surgical instrument used for division ("morcellation") and removal of large masses of tissues during laparoscopic surgery.[1] It can consist of a hollow cylinder that penetrates the abdominal wall, ending with sharp edges[1] or cutting jaws,[2] through which a grasper can be inserted to pull the mass into the cylinder to cut out an extractable piece.[1][2]

Morcellation devices in surgery[edit]

Laparoscopic morcellation is commonly used at surgery to remove bulky specimens from the abdomen using minimally invasive techniques. Historically, morcellation was performed using a device that required the surgeon or assistant to manually 'squeeze' the handle. Other reports describe using a scalpel directly through the abdomen to create small specimens that can be drawn out of the abdominal cavity. In 1993, the first electric morcellator was introduced in the US market. It was initially used for uterine extraction, but later applied to other organs. The use of morcellators at surgery has now become commonplace, with at least 5 devices currently on the US market. Despite decades of experience, there remains limited understanding of the short-term and long-term sequelae of morcellation. Concerns have been raised about injury to surrounding organs including bowel, bladder, ureters, pancreas, spleen and major vascular structures. Long-term issues may include parasitic growth of retained tissue with the potential to cause adhesions, cause bowel dysfunction and potentially disseminate unrecognized cancer.

Safety concerns of morcellation devices in gynecologic surgery[edit]

Morcellation is associated with spreading of cellular material of the morcellated tissue. In gynecologic surgery for benign pathologies there is approximately a 0.09% risk of an unexpected leiomyosarcoma. After morcellation 64% of such cases may develop disseminated disease which is of particular concern because of the considerable mortality of leiomyosarcoma. Morcellation of the more frequent benign leiomyoma variants may also cause disseminated disease, which while not associated with increased mortality is frequently inoperable and therefore more difficult to manage than the original disease.[3][4]

On April 17, 2014 the Food and Drug Administration issued a warning that morcellators may spread occult cancer in the course of fibroid removal.[5] Johnson & Johnson subsequently suspended sale of its morcellators until the role of morcellation "is redefined by the FDA and the medical community."[5]

See also[edit]

•                Instruments used in general surgery

References[edit]

1.             ^ Jump up to: 
a b c Disposable laparoscopic morcellator, GM Savage, JJ Christian, DC Dillow - US Patent 6,039,748, 2000

2.             ^ Jump up to: 
a b Morcellator, Jude S. Sauer, Roger J. Greenwald, Mark A. Bovard, John F. Hammond - US Patent 5562694. Issue date: Oct 8, 1996.

3.             Jump up 
^ Seidman, M. A.; Oduyebo, T.; Muto, M. G.; Crum, C. P.; Nucci, M. R.; Quade, B. J. (2012). "Peritoneal Dissemination Complicating Morcellation of Uterine Mesenchymal Neoplasms". In Sullivan, David J. PLoS ONE 7 (11): e50058. doi:10.1371/journal.pone.0050058. PMC 3506532. PMID 23189178. edit

4.             Jump up 
^ Cucinella, G.; Granese, R.; Calagna, G.; Somigliana, E.; Perino, A. (2011). "Parasitic myomas after laparoscopic surgery: An emerging complication in the use of morcellator? Description of four cases". Fertility and Sterility 96 (2): e90–e96. doi:10.1016/j.fertnstert.2011.05.095. PMID 21719004. edit

^ Jump up to: 
a b Robert Lowes (April 30, 2014). "J&J Suspends Power Morcellator Sales Over Cancer Risk". Medscape. Retrieved April 30, 2014.