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Morcellation Media Monitoring 04/11/2016
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FDA approves tissue container for laparoscopic device
Apr 7, 2016 | Reuters
By Rosmi Shaji
The U.S. Food and Drug Administration approved a tissue container bag for use in certain laparoscopic procedures along with power morcellators, that have been linked to the spread of cancer in women. -
FDA approves add-on to controversial surgical device
Apr 7, 2016 | The Philadelphia Inquirer
By Marie McCullough
The U.S. Food and Drug Administration on Thursday announced the approval of the first tissue-containment bag for use with a gynecological surgical device that can spread undetected cancer. -
FDA allows marketing of first-of-kind tissue containment system for use with certain laparoscopic power morcellators in select patients
Apr 7, 2016 | Press Release
By FDA
The U.S. Food and Drug Administration today permitted the marketing of PneumoLiner, the first tissue containment system for use with certain laparoscopic power morcellators to isolate uterine tissue that is not suspected to contain cancer. Although the device is an effective tissue containment system, the FDA is requiring the manufacturer to warn patients and health care providers that PneumoLiner has not been proven to reduce the risk of spreading cancer during these procedures. -
FDA nod for tissue containment in power morcellation comes amid ongoing review of cancer concerns
Apr 8, 2016 | Fierce Medical Devies
By Stacy Lawrence
Irish startup Advanced Surgical Concepts has nabbed an FDA nod for its tissue containment system for use with certain laparoscopic power morcellators. The regulatory go-ahead falls under the agency's de novo process that's reserved for low- to moderate-risk devices that are novel. -
FDA OKs Marketing of Morcellation Tissue Containment System
Apr 7, 2016 | Medscape
By Marcia Frellick
The US Food and Drug Administration (FDA) today permitted the marketing of the first tissue containment system for use with certain laparoscopic power morcellators to isolate uterine tissue that is not suspected to contain cancer. -
FDA Approves First-Of-Its-Kind Container Bag For Certain Power Morcellator Procedures
Apr 11, 2016 | Med Device
By Jof Enriquez
The U.S. Food and Drug Administration (FDA) has approved through the de novo classification process PneumoLiner, a first-of-its-kind tissue container bag for use in certain laparoscopic power morcellator procedures to isolate uterine tissue that is not suspected to be cancerous. -
FDA Says No Guarantees New Tissue Containment System Will Lessen Cancer Risks from Power Morcellation
Apr 7, 2016 | Mesh News Desk
Even amid an intense debate about the validity of using a power morcellator and its potential to spread previously undiagnosed cancers, the U.S. Food and Drug Administration today okayed the marketing of the first tissue containment system to use be used with the device. -
TAG Obstetrics and Gynecology, FDA, Uterus, Uterine Fibroid, Laparoscopic Power Morcellation Tissue Container Bag For Uterine Surgeries Gets FDA Approval
Apr 9, 2016 | Tech Times
By Angela Laguipo
The Food and Drug Administration has approved the marketing of the first ever tissue container bag for uterine surgeries involving laparoscopic procedures with power morcellators.
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Full Text of Stories Below
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FDA approves tissue container for laparoscopic device
Apr 7, 2016 | Reuters
By Rosmi Shaji
The U.S. Food and Drug Administration approved a tissue container bag for use in certain laparoscopic procedures along with power morcellators, that have been linked to the spread of cancer in women.
Power morcellators are devices used in gynecological procedures like hysterectomy where the uterus or the uterine fibroids are cut into smaller pieces and extracted through small incisions.
The tissue container bag, PneumoLiner, developed by privately held Advanced Surgical Concepts Ltd, is then inserted into the abdomen and the tissues removed during the procedure are placed into it.
The FDA estimates that about 1 in 350 women who undergo surgical procedures for fibroids is found to have an unsuspected uterine cancer.
If morcellation is performed on these women, there is a risk that it will spread the cancerous tissue within the abdomen and worsen the patient's likelihood of long-term survival, the FDA said in a statement. (1.usa.gov/1qa18Ci)
The health regulator, in 2014, had warned against using these morcellators for surgical purposes as they flagged serious risks such as the spread of cancer.
Johnson & Johnson immediately suspended the worldwide sales of its morcellator after the FDA imposed the warning. (reut.rs/1SDgiXP)
The FDA said on Thursday that the PneumoLiner's label should contain a boxed warning stating that the use of these container bags does not reduce the risk of cancer that might spread through using the power morcellators.
Boxed warning is issued by the FDA to flag serious risks associated with using a drug or a device.
Uterine fibroids are non-cancerous growths that originate from the smooth muscle tissue in the wall of the uterus. Laparoscopic power morcellation is one of several available treatments for fibroids.
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FDA approves add-on to controversial surgical device
Apr 7, 2016 | The Philadelphia Inquirer
By Marie McCullough
The U.S. Food and Drug Administration on Thursday announced the approval of the first tissue-containment bag for use with a gynecological surgical device that can spread undetected cancer.
At the same time, the agency continued to warn that the tissue-slicing surgical device, called a power morcellator, should not be used in most cases. And the FDA further warned that the new bag "has not been proved to reduce the risk of spreading cancer."
The FDA estimates that about 1 in 350 women who undergo hysterectomy or uterine fibroid removal will have an unsuspected sarcoma, an aggressive uterine cancer. If the surgery is done with a power morcellator, the procedure can spread the cancer and worsen the patient's prognosis.
The FDA was unaware of that danger until late 2013, when anesthesiologist Amy Reed and her husband, cardiac surgeon Hooman Noorchashm, began campaigning to ban electric morcellators. Reed's undetected sarcoma was spread by the device during a hysterectomy at Brigham & Women's Hospital in Boston.
The couple and their six children now live in the Philadelphia area, where she is battling the metastatic cancer.
The newly approved containment bag, called PneumoLiner, is intended to provide an enclosed working space for the morcellator inside the woman's abdominal cavity, enabling capture and removal of all morcellated tissue. In laboratory tests, the bag did not leak cells or body fluids, and it withstood the pulling and other forces expected to occur during actual use.
Noorchashm denounced the approval of the bag as "astonishing" and irresponsible, given that the FDA has not changed its position that power morcellation poses serious risks.
Introduced in 1993, electric morcellators have motorized blades that dissect tissue so it can be removed through tiny abdominal incisions. Patients recover faster than with the traditional cut-open-the-abdomen hysterectomy. About 50,000 hysterectomies a year involved the device before the controversy erupted a couple of years ago, sharply lessening its use.
The FDA now says it should be used only in relatively rare cases, such as some pre-menopausal women who want to get rid of fibroids but preserve their fertility by leaving the uterus intact.
"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," FDA deputy director William Maisel said in a news release.
PneumoLiner is made by Advanced Surgical Concepts Ltd. of Bray, Ireland. The FDA said the product was reviewed under regulations for "low- to moderate-risk devices that are first-of-a-kind."
The labeling for PneumoLiner will include a prominent warning that "the use of this containment system has not been clinically demonstrated to reduce the risk" of spreading an unsuspected uterine cancer.
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Apr 7, 2016 | Press Release
By FDA
The U.S. Food and Drug Administration today permitted the marketing of PneumoLiner, the first tissue containment system for use with certain laparoscopic power morcellators to isolate uterine tissue that is not suspected to contain cancer. Although the device is an effective tissue containment system, the FDA is requiring the manufacturer to warn patients and health care providers that PneumoLiner has not been proven to reduce the risk of spreading cancer during these procedures.
Based on an analysis of currently available data, the FDA has estimated that approximately 1 in 350 women who undergo hysterectomy or myomectomy for fibroids is found to have an unsuspected uterine sarcoma. If morcellation is performed on these women, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival. At this time, the PneumoLiner device has not been proven to reduce the spread of potentially cancerous tissue during power morcellation.
“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,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health. “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.”
The PneumoLiner is intended to be used only in a limited patient population, including women without uterine fibroids undergoing hysterectomy and some pre-menopausal women with fibroids who want to maintain their fertility; a small number of women may find, after consultation with their doctor, that laparoscopic power morcellation is an appropriate therapeutic option compared to more invasive surgery. For these women, the device is intended to isolate and contain tissue that is considered to be non-cancerous before surgery even if that tissue is subsequently determined to be cancerous. However, Maisel warned, “We want to be clear that, although the device has been shown to successfully contain morcellated tissue, it has not been proven to reduce the risk of cancer spread during surgery.”
The device consists of a containment bag and a tube-like plunger to deliver the device into the abdominal cavity where the tissue to be removed is placed in the bag and the bag is sealed and inflated. Inflation allows for the creation of 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. It was tested in laboratory settings to simulate actual use and worst-case scenario conditions. The containment bag was found to be impermeable to substances that were similar in molecular size to tissues, cells and body fluids, and other testing determined that the inflated bag provided adequate space for surgeons to perform morcellation with good visualization. Stress testing to evaluate the bag’s mechanical strength demonstrated that the device could withstand forces in excess of those expected to occur in actual clinical use.
Risks associated with the PneumoLiner device include dissemination of morcellated tissue, injury to surrounding tissues or organs, infections and a prolongation of the surgical procedure. The required labeling for the device must state that use of the device is limited to physicians who have successfully completed the company’s validated training program.
To alert women and health care providers to the risks associated with power morcellation of uterine tissue, the labeling for PneumoLiner must include the following boxed warning, which is similar to the recommended warning for laparoscopic power morcellators:
-“Warning: Information regarding the potential risks of a procedure with this device should be shared with patients. Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer. The use of this containment system has not been clinically demonstrated to reduce this risk.”
The labeling must also contain the following important contraindications regarding the limited patient population in which the device is to be used:
-Do not use in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy.
-Do not use for removal of uterine tissue containing suspected fibroids in patients who are: peri- or post-menopausal; or candidates for en bloc tissue removal, for example, through the vagina or via a mini-laparotomy incision.
The FDA continues to review information on laparoscopic power morcellation, including the latest data and evolving scientific literature, and will communicate publically on any developments that are pertinent to the agency’s thinking on this issue.
The FDA reviewed PneumoLiner through its de novo classification process, a regulatory pathway for some novel, low- to moderate-risk medical devices that are first-of-a-kind. The device is manufactured by Advanced Surgical Concepts Ltd. located in Bray, Ireland.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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FDA nod for tissue containment in power morcellation comes amid ongoing review of cancer concerns
Apr 8, 2016 | Fierce Medical Devies
By Stacy Lawrence
Irish startup Advanced Surgical Concepts has nabbed an FDA nod for its tissue containment system for use with certain laparoscopic power morcellators. The regulatory go-ahead falls under the agency's de novo process that's reserved for low- to moderate-risk devices that are novel.
Power morcellation is at the center of a years-long controversy surrounding its role in potentially spreading previously undetected cancer throughout a patient's body when the minimally invasive procedure is used for hysterectomy or uterine fibroid removal. The procedure works by shredding the tissue targeted for extraction, eliminating the need for invasive surgery.
The tissue containment system, PneumoLiner, is specifically cleared by FDA for uterine tissue that is not suspected to contain cancer. The idea is to contain what is thought to be noncancerous tissue, thereby reducing the likelihood that any tissue is distributed further into the body during power morcellation. But these are precisely the types of cases, where no cancer was previously suspected, that have been seen as problematic for use of the procedure. The agency estimates that about 1 in 350 women who undergo hysterectomy or fibroid removal have unsuspected uterine cancer.
"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," said Dr. William Maisel, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health, in a statement.
He continued, "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."
Most recently, one major power morcellator maker, Johnson & Johnson ($JNJ) has moved to settle about 70 out of the 100 cases against it on this front. The settlements reportedly range in the $100,000 to $1 million range per woman. Although several prominent doctors recently came out in defense of the procedure, it already carries a 'black box' warning from the FDA that dates back to 2014. And some insurers have backed away from reimbursing for it in light of the controversy.
The FDA said it "continues to review information on laparoscopic power morcellation, including the latest data and evolving scientific literature, and will communicate publically on any developments that are pertinent to the agency's thinking on this issue."
An approach like the PneumoLiner from the Bray, Ireland-based endoscopic surgical device startup may be a first step in moving ahead in the power morcellation quagmire. The device includes a containment bag and a tube-like plunger to deliver it into the abdominal cavity. The tissue to be removed is placed in the bag, which is then sealed and inflated. Then morcellation occurs inside the sealed bag.
Visualization during morcellation is used to prevent any breakage of the containment bag, which was found in testing to be impermeable to substances similar in molecular size to tissues, cells and body fluids. The bag has already been stress tested to demonstrate that it can withstand forces in excess of what's expected in actual use.
The PneumoLiner is cleared by the FDA specifically for women without uterine fibroids who are undergoing a hysterectomy and some premenopausal women with fibroids who want to keep their uterus, thereby maintaining their fertility.
Cautioned FDA's Maisel, "We want to be clear that, although the device has been shown to successfully contain morcellated tissue, it has not been proven to reduce the risk of cancer spread during surgery."
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FDA OKs Marketing of Morcellation Tissue Containment System
Apr 7, 2016 | Medscape
By Marcia Frellick
The US Food and Drug Administration (FDA) today permitted the marketing of the first tissue containment system for use with certain laparoscopic power morcellators to isolate uterine tissue that is not suspected to contain cancer.
However, the FDA is requiring the manufacturer of the device, called PneumoLiner, to warn patients and their healthcare providers that it has not been proven to reduce the risk of spreading cancer during these procedures.
The FDA estimates that about 1 in 350 women who have hysterectomy or myomectomy for fibroids will have an unsuspected uterine sarcoma.
If morcellation, or the shredding and removal of tissue, is performed on them, there is a risk that the cancerous tissue could spread to the abdomen and pelvis and significantly threaten long-term survival.
"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, MD, MPH, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health, said in a news release.
"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," Dr Maisel added.
The FDA says the PneumoLiner is intended as an alternative to more invasive surgery only in very limited cases, including women without uterine fibroids undergoing hysterectomy and some premenopausal women with fibroids who want to preserve fertility.
Risks of the device include dissemination of shredded tissue, injury to surrounding tissues or organs, and infections.
"The required labeling for the device must state that use of the device is limited to physicians who have successfully completed the company's validated training program," the FDA said.
According to the FDA statement, the device, which consists of a containment bag and tubelike plunger, was tested in laboratories to simulate worst-case scenarios.
"The containment bag was found to be impermeable to substances that were similar in molecular size to tissues, cells and body fluids, and other testing determined that the inflated bag provided adequate space for surgeons to perform morcellation with good visualization. Stress testing to evaluate the bag's mechanical strength demonstrated that the device could withstand forces in excess of those expected to occur in actual clinical use," the FDA statement said.
Morcellation Opponent Furious With Approval
Hooman Noorchashm, MD, a cardiothoracic surgeon, toldMedscape Medical News, "I find this a completely astonishing statement. Despite all the demonstrated catastrophe this device has caused, they've gone ahead and approved a device — this federal agency is admitting now that the cancer risk of this device is unknown — and yet they're OK with unleashing it into the marketplace. What do they expect? That gynecologists will use their patients as guinea pigs? It's completely atrocious.... How could they let this device into the marketplace without demanding some sort of clinical study to demonstrate safety?"
Dr Noorchashm has waged a high-profile campaign against gynecological morcellation since his wife, anesthesiologist Amy Reed, MD, PhD, underwent a hysterectomy in 2013 for uterine fibroids at Brigham and Women's Hospital in Boston, Massachusetts. According to the previous Medscape Medical News story, her surgeon used a morcellator to shred the fibroids, believed to be benign, into pieces that were extracted through tiny laparoscopic incisions. A week later, Dr Reed's physicians told her she had an aggressive uterine leiomyosarcoma, and that morcellation may have spread the previously unknown cancer throughout her abdomen, according to her husband.
A subsequent operation confirmed that morcellation and its tissue-scattering action had advanced the cancer to stage IV, Dr Noorchashm said.
Dr Noorchashm said he will continue to advocate recalling all laparoscopic power morcellators.
The PneumoLiner, manufactured by Advanced Surgical Concepts Ltd in Bray, Ireland, was reviewed through the FDA's de novo classification process, used for some first-of-a-kind, novel, low- to moderate-risk medical devices.
The FDA further states that labeling must include these warnings: "Do not use in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy; and do not use for removal of uterine tissue containing suspected fibroids in patients who are: peri- or post-menopausal; or candidates for en bloc tissue removal, for example, through the vagina or via a mini-laparotomy incision."
Important Contraindications
Daniel L. Clarke-Pearson, MD, professor and chair of the Department of Obstetrics and Gynecology at University of North Carolina in Chapel Hill, said those contraindications are important, as is informed consent.
He told Medscape Medical News: "While uterine cancers (especially leiomyosarcoma) are extremely rare (and most feel much less common than the 1/350 estimated by the FDA), the patient should be properly informed of her choices and risks before undertaking morcellation within or out of a containment bag."
He said systems similar to this device that have not been approved by the FDA have been used with increasing frequency by providers performing minimally invasive gynecologic surgery to prevent tissue dissemination.
"There is no evidence available to support a decrease in the spread of a uterine leiomyosarcoma between hand morcellation, vaginal morcellation, or power morcellation in contained environments. The benefit of laparoscopic power morcellation is providing appropriate candidates an option of completing a minimally invasive procedure laparoscopically," he said.
Dr Clarke-Pearson added that other specialties, such as urology, have used contained morcellation for known cancer extraction in the setting of minimally invasive kidney removal.
"This device would be most useful in removing a uterus," he said. "However, in performing a myomectomy, the uterus is cut into and manipulated before the myoma (fibroid) would be placed into the containment bag. Thus, if the myoma were cancerous, there would have been spread before placing the myoma in the containment bag."
He said it was disconcerting that the FDA said more than once in its announcement that "it has not been proven to reduce the risk of cancer spread during surgery."
But he agrees with the FDA that proper training of the surgeon is critical.
"There have been vascular and bowel injuries by power morcellators when using a containment bag because the bag itself can obstruct the surgeon's view of adjacent anatomy and thus, the morcellator has penetrated out the opposite side of the bag and injured organs that were not visualized," he said. "I presume this bag is not so strong as to withstand the blades of the power morcellator."
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FDA Approves First-Of-Its-Kind Container Bag For Certain Power Morcellator Procedures
Apr 11, 2016 | Med Device
By Jof Enriquez
The U.S. Food and Drug Administration (FDA) has approved through the de novo classification process PneumoLiner, a first-of-its-kind tissue container bag for use in certain laparoscopic power morcellator procedures to isolate uterine tissue that is not suspected to be cancerous.
According to the FDA announcement, the PneumoLiner device consists of a containment bag and a tube-like plunger to deliver the device into the abdominal cavity, where the tissue to be removed is placed in the bag and the bag is sealed and inflated. The bag is impermeable to tissues, cells, and body fluids, and has enough space for the surgeon to perform morcellation.
Power morcellators are devices used in laparoscopic surgeries to remove the uterus (hysterectomy) or to remove uterine fibroids (myomectomy) to divide or mince tissues into small fragments or pieces. FDA previously warned that the use of said devices could inadvertently spread uterine cancer cells through adjacent body areas, such as the abdomen and pelvis, and the Administration discourages their use in the majority of cases. The FDA estimates that about 1 in 350 women who undergo a hysterectomy or myomectomy for fibroids could have an unsuspected uterine sarcoma.
FDA is allowing the use of PneumoLiner, but the device is only permitted when the uterine tissue to be morcellated is not suspected to be cancerous before surgery, and only for women without uterine fibroids undergoing hysterectomy, and some pre-menopausal women with fibroids who want to maintain their fertility. It should not be used to remove uterine tissue containing suspected fibroids in patients who are: peri- or post-menopausal; or candidates for en bloc tissue removal, for example, through the vagina or via a mini-laparotomy incision.
In addition to the narrow indication, FDA requires the labeling for PneumoLiner to carry the following boxed warning, which is similar to the recommended warning for laparoscopic power morcellators: “Information regarding the potential risks of a procedure with this device should be shared with patients. Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer. The use of this containment system has not been clinically demonstrated to reduce this risk.”
William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health (CDRH), said in a statement, “We want to be clear that, although the device has been shown to successfully contain morcellated tissue, it has not been proven to reduce the risk of cancer spread during surgery.”
According to FDA, known risks of the PneumoLiner device include dissemination of shredded tissue, injury to surrounding tissues or organs, and infections.
“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,” said Maisel. “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.”
FDA in 2014 warned against using power morcellators for surgical purposes because of serious risks, such as the spread of cancer, according to Reuters. As a result, Johnson & Johnson immediately suspended the worldwide sales of its morcellators. J&J and other manufacturers have faced multiple lawsuits linking the devices to cases of metastatic cancer.
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Apr 7, 2016 | Mesh News Desk
Even amid an intense debate about the validity of using a power morcellator and its potential to spread previously undiagnosed cancers, the U.S. Food and Drug Administration today okayed the marketing of the first tissue containment system to use be used with the device.
The PneumoLiner has not been proven to reduce the risk of spreading uterine sarcoma and the FDA will require the manufacturer to state just that.
It’s estimated about one in 350 women have an unidentified uterine sarcoma, sometimes being hidden in a fibroid. A morcellator shreds and removes tissues during a hysterectomy or fibroid removal, but an undiagnosed uterine sarcoma will be spread within the abdomen and pelvis worsening the patient’s chance of a long-term survival.
The PneumoLiner will contain that morcellated tissue. “But only if patients have been appropriately informed of the risks,” says William Maisel, MD with the Center for Devices and Radiological Health, the medical device division of the FDA.
The FDA continues to warn against the use of the power morcellator but has not issued a recall. Doctors and hospitals can use their own discretion on whether or not to continue using it.
Dr. Hooman Noorchashm, a cardiothoracic surgeon, whose wife, Dr. Amy Reed, is fighting cancer following a morcellation procedure, calls the approval “atrocious.” Speaking to Medscape Medical News here, he says:
"I find this a completely astonishing statement. Despite all the demonstrated catastrophe this device has caused, they’ve gone ahead and approved a device — this federal agency is admitting now that the cancer risk of this device is unknown — and yet they’re OK with unleashing it into the marketplace. What do they expect? That gynecologists will use their patients as guinea pigs? It’s completely atrocious…. How could they let this device into the marketplace without demanding some sort of clinical study to demonstrate safety?”
Undergoing a morcellation procedure for a hysterectomy in 2013, Dr. Reed’s surgeon shredded fibroids with the morcellator. The small pieces, believed to be benign, were extracted through a tiny laproscopic incision.
One week after the morecellation, she was diagnosed with an aggressive uterine leiomyosarcoma which had now advanced to stage IV.
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Apr 9, 2016 | Tech Times
By Angela Laguipo
The Food and Drug Administration has approved the marketing of the first ever tissue container bag for uterine surgeries involving laparoscopic procedures with power morcellators.
The new device, called PneumoLiner, is a tissue containment system that works by isolating uterine tissue not assumed to contain cancerous cells.
Power morcellators are used in certain procedures where the uterus or uterine fibroids are cut into smaller pieces and extracted through incisions. However, it has been linked to cancer spread among women.
It Has Not Been Proven Effective In Cutting Cancer Risk
Though PneumoLiner shows promise in tissue containment, the federal regulators require the manufacturer to warn patients, doctors and health practitioners that the device has not been proven effective in reducing the risk of cancer spread during procedures.
The FDA has estimated that about one in 350 women who were subjected to hysterectomy (removal of the uterus) and myomectomy (removal of fibroids), is found to have unknown uterine sarcoma, a form of cancer.
When women undergo morcellation, there is an increased risk that the procedure will cause the spread of cancerous cells and tissues within the pelvis and abdomen, which will worsen the condition of the patient.
How Does It Work?
A plunger is used to deliver the PneumoLiner into the abdominal cavity. The tissue will be removed and placed inside the bag. After which, it will be sealed and inflated, allowing better visualization.
Inflation is needed to have a clearer view of the site by having ample working space around the tissue. This will prevent the breakage of the containment bag since the morcellator could puncture it.
Reviewing Information
In 2014, the use power morcellators has been banned by the federal regulatory agency. Uterine fibroids may have potentially fatal hidden cancer called leiomyosarcoma, and morcellators may cause spread of these cancerous cells.
The FDA is still reviewing information on laparoscopic power morcellation and it will relay information to the public on any developments on the issue.
It also alerts women and their doctors of the risks linked to power morcellation of uterine tissue. A warning label should be included in the device's packaging.
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