Morcellator Device Violates Standard of Care

A California surgeon Hysterectomy Sarcoma Attorneyhas said the morcellation device violates the standard of care.  V.G. Hufnagel, MD, said that she warned Johnson & Johnson back in 1993 that the morcellator would spread disease. The doctor said she told J&J and German morcellator maker Karl Stortz that morcellation would trigger infection, endometriosis, adonomyosis, and fibroids.  The doctor also says she told J&J and Karl Stortz that their morcellation devices would kill women with sarcoma.

Morcellator Design Flawed
Dr. Hufnagel, who said she was the first California surgeon to remove a fibroid with a laparascope, has also reported that she told J&J the morcellator was not properly designed.  She says she told J&J that tissue cannot be chopped up and then spread all throughout the pelvic cavity.

The “Unexpected Cancer” Lie: How Morcellator violates Standard of Care
Dr. Hufnagel, a self-described whistleblower, said that the morcellator device violates the standard of care.  She said the standard of care is simple:  “All tissues need to be evaluated for cancer and other conditions before operating on any woman.”

The problem is that no reliable test can now evaluate whether or not a woman’s uterine fibroids are cancerous.  Consequently, any surgeon morcellating a woman’s fibroids is taking a chance that they are not cancerous.   One wrong guess can kill the patient.

Surgical Oncology – Unambiguous Rules
Dr. Hufnagel says that surgeons and morcellator makers try to explain the unfortunate results as “unexpected cancer.”  Dr. H. Cries foul on that explanation.  She says that surgeons and device makers have “fabricated the concept of ‘unexpected tumor’ and ‘unexpected cancer’.  She says they use those marketing and false medical finding/diagnostic terms to “take away [or cover up] the full knowledge that all have had.”

The surgeon says that during any operation, “all tissues must be treated as if they are cancer.”  The doctor wrote:  “In the morcellaton process all of the science used to develop oncological protocol to give the best outcome for the patient was and is totally ignored.  It is truly madness.  A chopper is racing about chopping up tissue emulsifying it into small particles and with it speeds spreading tissue about the body.”

Morcellator Device Violates Standard of Care
Dr. Hufnagel also explains that without full knowledge of the dangers of morcellation, women cannot give their informed consent to a procedure that involves the use of a morcellator.

Surgeon Files Formal Legal Complaint
Dr. Hufnagel filed a formal legal complaint against morcellator makers on Dec. 31, 2015.  Her petition includes the claim that she redesigned the device in 1995, which she says she showed and explained to the medical device committee of the FDA.

Dr. Hufnagel’s petition also includes the claims that she wears several hats. She is:

•  a gynecological surgical ethics specialist

•  creator of a new surgical branch of gynecology called Female Reconstructive Surgery before 1985

•  a student of Kurt Semm ( Germany) and Viktor Bonney (UK)

•  the first physician to write law to protect patients in the USA, Calif., Texas, New York with informed consent for hysterectomy

•  an internationally known women’s health care expert and whistle-blower on abuses.

Dr. Hufnagel, however, is not the first physician to announce that morcellation violates the standard of care.  Dr. Amy Reid and her husband, Dr. Hoonan Noorchashm, have also spoken out about the problems of morcellating cancer tissue.  Dr. Reid, a mother of five, died of cancer this past Spring after a morcellator was used on her.

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Doctor Who Denounced Morcellator Dies

A medical doctor who denounced morcellators has died, likely because of a morcellator that was used on her.  Dr. Amy Reed, a mother of six children, died from cancer May 23, 2017, after fibroid removal surgery spread cancer cells throughout her body. Surgeons had used a morcellator on her to remove precancerous uterine fibroids. Dr. Reed died at her Yardley, Pa., home. She was 44.  Dr. Reed is survived by her husband and six children.

Morcellator Lawsuit
The doctor and her physician husband filed a morcellator lawsuit against Johnson & Johnson, makers of the morcellator that was used on her. Dr. Reed and her husband denounced the morcellator device which hastened the spread of her cancer. She and her husband, Dr. Hooman Noorchashm, a cardiothoracic surgeon, had held teaching posts at Brigham and Women’s Hospital in Boston, which is affiliated with Harvard Medical School. There, both Dr. Reed and Dr. Noorchashm had teaching positions. A post operation biopsy found Dr. Reed had a hidden leiomyosarcoma. Dr. Noorchashm later called the morcellator a threat to national security. As a surgeon himself, Dr. Noorchashm was incensed at the notion of shredding potentially cancerous tissue inside a body cavity. He had been trained to cut around tumors, not through them, precisely because slicing into them could spread cancer cells.

Leiomyosarcoma Death
Dr. Reed’s cause of death was listed as a type of cancer called leiomyosarcoma. This uterine cancer was greatly accelerated by a botched operation in 2013, when the doctor first went under the knife for the removal of precancerous fibroids. Dr. Reed was told that it was safe to surgically remove the fibroids with the high-powered tool called a morcellator.

Morcellator Device
The morcellator device works by slicing up tissue and vacuuming up cancerous cells piece by piece. The morcellator was approved by the U.S. FDA in 1995. The device has a spinning blade that slices up tissue so that it can be extracted through small incisions. Many surgeons regard it as a great boon to minimally invasive surgery, but if a patient has cancer, as Dr. Reed did, morcellation can worsen and spread the disease. The problem is that fibroids can’t be reliably distinguished from leiomyosarcoma.

The morcellator operation exacerbated Dr. Reed’s condition. The tool had spread harmful cancer cells inside her body. In just minutes, the slicing and dicing elevated her disease status from stage I to stage IV cancer. Days after her initial operation, biopsy reports revealed Dr. Reed had hidden leiomyosarcoma, a rare and aggressive cancerous soft tissue tumor.

Doctor Who Denounced Morcellator Dies
Dr. Reed then embarked on an extensive treatment plan that included chemotherapy radiation, immunotherapy, and experimental treatments. She also underwent several major operations. Meanwhile, the cancer kept spreading, to her lungs, spine, abdomen. Following the first surgery, both Dr. Reed and Dr. Noorchashm pushed for FDA to ban power morcellators. They sent thousands of emails to the FDA and several sectors across the country. They also emailed device makers, hospitals, legislators, professional societies, individual doctors, and news outlets.

One in 350 Women Affected
The devastated pair attained a major victory in 2014, a year after Dr. Reed’s surgery. They got the FDA to examine published and unpublished data on morcellation. Earlier estimates showed that between one in 10,000 to in one in 500 women with fibroids could have undiagnosed leiomyosarcomas or other uterine sarcomas. In April 2014, the FDA reevaluated. The agency concluded that hidden sarcomas were more common, affecting one in 350 fibroid cases. Soon afterwards, Johnson & Johnson pulled its morcellators from the market.

In November of 2014, the doctor pair gained another victory, as FDA released recommendations against using morcellators in a majority of women with uterine fibroids. The agency said that using the power morcellator on fibroid patients with hidden sarcoma could spread the cancer and reduce the patients’ mortality. The FDA also stressed that the statement should be treated as a “safety communication.” It did not issue any new regulation for morcellators.

Sadly, any victories the couple gained for morcellator safety came too late to help Dr. Reed.  But heroically, she successfully turned a personal tragedy into a crusade to save other women from the procedure that had so harmed her.

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Morcellator Options for Fibroids

Power Morcellator Surgery Riskmorcellators are not the only option for hysterectomy, myomectomy, or the removal of uterine fibroids, which some 80% of women can develop in their lifetimes.

In April 2014, the FDA announced in a safety alert that it wants to discourage the use of power morcellators. the problem is that some women may have undiagnosed uterine cancer which a morcellator can upstage, magnify, and make more dangerous, even deadly.

FDA Warning

FDA warned on April 17, 2014:

“Based on an analysis of currently available data, the FDA has determined that approximately 1 in 350 women who are undergoing hysterectomy or myomectomy for fibroids have an unsuspected type of uterine cancer called uterine sarcoma. If laparoscopic power morcellation is performed in 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.”

Risk of Power Morcellaton

Power morcellation is less invasive than traditional forms of surgery; but it also carries the risk of spreading benign or malignant tissue when used during myomectomies or hysterectomies for fibroid treatment or uterus removal.

Alternatives to Power Morcellation
The FDA acknowledged that power morcellators are less invasive (as advertised) than traditional approaches. They require fewer sutures; but nonetheless the FDA’s Obstetrics and Gynecology Devices Advisory Panel recommends that women seek, and that surgeons use, alternative methods. Several non-surgical treatments exist for fibroids, including expectant management, pharmaceutical therapy, uterine artery embolization, endometrial ablation.

Surgical Options for Fibroid Treatment
If a woman does require surgery, she and her doctor can decide between a hysterectomy, complete removal of the uterus; or a myomectomy, which targets only the fibroids. Many factors enter into this decision, including age, a (possible) desire for pregnancy, history of atypical cervical or endometrial cells, family history of cancer, risk of fibroids’ return.

Traditional Options: Hysterectomy & Myomectomy

The traditional option for removing the uterus is total abdominal hysterectomy, which the FDA says is the most common surgical choice. This involves a surgical incision in the wall of the lower abdomen, compared with laparoscopic hysterectomy, which takes less time and usually produces fewer urinary tract injuries.

Supracervical, or subtotal, hysterectomy and total vaginal hysterectomy are other options. According to the American College of Obstetricians and Gynecologists, vaginal hysterectomy is the most preferred option due to benefits it provides compared with alternatives. FDA says vaginal hysterectomy allows faster recovery and less of a chance of inducing infections than abdominal hysterectomy.

When fibroids are removed instead of the entire uterus, an open abdominal myomectomy is a traditional option. This involves an abdominal wall incision similar to an abdominal hysterectomy, and it precludes the need for morcellation.

Risks of Laparoscopic Treatment

According to FDA, compared with vaginal hysterectomy, the laparoscopic alternative may cause more complications during surgery, more transfusions, and a longer time spent in the operating room. Laparoscopic hysterectomy uses multiple small incisions in the abdomen wall along with gas and visualization instruments. It is during these types of procedures that surgeons often use power morcellators to allow large tissue to be extracted.

The types of laparoscopic hysterectomy include laparoscopic-assisted vaginal hysterectomy, total laparoscopic hysterectomy, and laparoscopic supracervical hysterectomy. Each of these types may, at some point during the procedure, require some form of morcellation to allow for complete uterine removal.

In minimally invasive laparoscopic myomectomy, power morcellation or the extending of incisions are ways of removing the cut fibroids. Morcellation may also be used during hysteroscopic myomectomy, a transvaginal procedure that does not require an abdominal incision, for fibroids found within the endometrial cavity and inner myometrium.

Alternative Surgical Techniques

To promote surgical techniques that mitigate the risks of power morcellation, various options have been suggested as possible ways to prevent spreading of tissue while maintaining the claimed benefits of minimally invasive procedures.

En-bloc resection techniques remove tissue completely intact, hoping to avoid power morcellation and the risk of spreading tissue pieces. To that end, methods could be used such as minilaparotomy, a surgically enlarged ancillary port; or transvaginal extraction. Each of those procedures comes with its own set of potential complications, however, and it is unclear whether any alleviate the risk of tissue dissemination.

Containment Bags and Other Strategies

Some industry representatives argue that leaving power morcellators on the market will drive companies to find new solutions to mitigate their risks. Proposed methods include vaginal morcellation and transvaginal extraction. Most common are techniques that involve containment bags.

Morcellator Options for Fibroids

Techniques in “bag morcellation” have been floated as a means of reducing the risk of spreading (potentially) cancerous tissue. But after the FDA examined the limited data for the permeability, integrity, and ability to execute various morcellation techniques within various surgical bags and other “containment strategies,” the agency could not verify the efficacy of any of those methods for reducing the morbid and cancer-spreading risks of power morcellators.

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Power Morcellator Investigation by Government

The U.S. Government morcellator uterine cancerAccountability Office (GAO) has still not issued any statement regarding its investigation into power morcellators used for hysterectomy or uterine fibroids. The GAO announced in Sept. 2015 that it would investigate controversy which had stemmed from wide use of power morcellators, and subsequent morcellator lawsuits. These gynecological devices are known to spread undetected cancers during hysterectomies and myomectomies.

Congressional Letter to GAO
The GAO’s action came after a dozen members of Congress wrote a letter requesting that the agency investigate. The legislators wrote the GAO a letter dated August 2, 2015:

“Hundreds, if not thousands, of women in America are dead because of a medical device known as a laparoscopic power morcellator. (This) device can take a Stage 1 treatable cancer immediately to a Stage 4 terminal cancer. For too many women, this routine procedure ended with a death sentence.”

The representatives’ letter was signed by Reps. Mike Fitzpatrick (R-Pa.), Louise Slaughter (D-N.Y.), Ralph Abraham (R-La.), Rosa DeLauro (D-Conn.), Bill Pascrell, Jr. (D-N.J.), Lou Barletta (R-Pa.), Doug LaMalfa (R-Calif.), Anna G. Eshoo (D-Calif.), Jan Schakowsky (D-Ill.), Chris Smith (R-N.J.), Stephen Lynch (D-Mass.), and Rick Larsen (D-Wash.).

FDA Limits Morcellator Use
FDA severely limited power morcellator use in November 2014, a year after doctors and patient advocates Amy Reed and Hooman Noorchashm launched a vigorous campaign against the device.

Morcellator National Security Threat
Dr. Amy Reed became a power morcellator victim after one was used on her for a hysterectomy. Her husband, Dr. Hooman Noorchashm then became something of a whistleblower. He announced that morcellators were a national security threat, given that 1 in 350 women have undetected uterine cancer prior to hysterectomy or fibroid removal. When that woman with undetected cancer undergoes surgery with a morcellator, her cancer can be morcellated – sliced and diced – into millions of pieces which are then spread everywhere throughout the uterus. The result can be aggressive uterine cancer or other type of cancer that can be fatal.

Doctors push Back
Some doctors, meanwhile, have pushed back against the proposed morcellator ban. The morcellator offers the convenience of a less invasive procedure. Fewer sutures are needed in using the morcellator, compared with the old methods used for hysterectomy and myomectomy or fibroid removal. The problem remains, however, that the ovarian cancer testing which doctors have used prior to surgery in order to diagnose possible cancer has not proven reliable.

Morcellator Lawuits
Against this backdrop, morcellator lawsuits have been filed across the country for women with undetected cancer who then underwent surgery with a power morcellator, only to find that the machine spread and worsened their undetected cancer.

Power Morcellator Investigation by Government

Meanwhile, the power morcellator investigation by the U.S. government continues. Stay tuned for further developments. . .

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Morcellator Cancer Complaint Filed

A medical Morcellator-btndoctor has filed a formal legal complaint demanding full investigation and prosecution of corporations that have made and promoted morcellation devices. The doctor also calls for prosecution of doctors who have used morcellators on women with (undetected) cancer, as well as organizations that have promoted their use, such as ACOG – the American Congress of Obstetricians and Gynecologists.

Dr. Vikki G. Hufnagel, MD, is Director of the Institute for Ethics Law, Science and Medicine. She addresses her complaint to the FTC, SEC, FINRA, BBB, FBI, OIG, Calif. Attorney General, California Senators Boxer and Feinstein, the Calif. Dept. of Insurance, Calif. Dept. of Affairs, members of the US Congress, and The Hague.

Crime of Morcellation Worldwide

Dr. Hufnagel writes: “To The Hague: This crime of morcellation with a device that spreads disease and death is taking place around the globe. Poor women have been used as experimental animals without being educated or given informed consent. The WHO does many fine things. However WHO also promotes testing on women in underdeveloped nations who are taken advantage of. Money is given to WHO for the promotion of studies on these women for corporations’ research and development.”

The doctor says The Hague must lead the action to educate and protect women around the world from medical abuse, harm and battery, and to insure their health and welfare.

The Mayhem of Morcellation

The doctor also said she is available to debate any agent for the ACOG, AMA etc. She says she will not stop her “attack” until the truth is known worldwide.

The Politics of Medicine
Physicians in other parts of the world do not get all the information they need to learn about the politics of medicine in America, according to Dr. Hufnagel. She writes that organizations such as the WHO and others take on research projects using poor, uneducated women to benefit corporations. The doctor demands to know who has been harmed in the development of morcellation.

Dr. Hufnagel asks that all agencies of the government stop these abuses by physicians and corporations which have killed or injured women worldwide. The doctor says she redesigned the device herself in 1995, then demonstrated her redesign to the medical device committee of the FDA.

She said she is filing the complaint “as a gynecological surgical ethics specialist, a creator of a new surgical branch of gynecology called Female Reconstructive Surgery prior to 1985, a student of Kurt Semm (Germany) and Viktor Bonney (UK), as the first physician to write law to protect patients in the U.S., Calif., Texas, New York with informed consent for hysterectomy, as an internationally known women’s health care expert and whistle-blower.

The doctor also advertises her services to assist law firms in morcellator lawsuits against morcellation device makers, doctors, medical organizations that have injured women. She said she wants to work towards “actual jail time for these crimes,” not just a slap on the wrist and monetary damages.

“Our society must change and be leaders of ethics protecting the people,” she wrote.

Morcellator Cancer Complaint Filed

Dr. Hufnagel lists her contact information on her complaint.

Dr. V.G. Hufnagel MD
Director of the Institute for Ethics Law, Science and Medicine.
vikkihufnagel@gmail.com
PST 323–210–3371 vm,
4244 Canoga Ave
Woodland Hills Ca 91364

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Ovarian Cancer Screening not reliable – FDA

FDA recommends Pelvic Mesh not approved by FDA – The 510(k) Bluesagainst using screening tests for ovarian cancer

While power morcellators can spread undetected uterine cancer when used for fibroid removal or hysterectomies, word comes from the FDA that current ovarian cancer screening is not reliable. Morcellators can spread undetected cancer during hysterectomy or fibroid removal and lead to more serious forms of uterine and ovarian cancer.

FDA issued a safety communication September 7, 2016 to women and physicians, including those working in Primary Care, Obstetrics and Gynecology, Oncology, Gynecologic Oncology, and Genetic Counseling.

Morcellator Safety Questions Abound
The FDA said it was especially concerned about delaying preventive treatments for symptomless women at increased risk of ovarian cancer. But at the same time, the FDA recommends against using currently offered ovarian cancer screening tests.

That announcement begs the question of whether it is safe or reasonable to use a morcellator for any woman’s hysterectomy or fibroid removal procedure. Though morcellators appear to be a safe option for women who do not have cancerous fibroids or ovarian cancer, if ovarian cancer screening is not reliable, how can it be considered safe to use a morcellator on any woman?

Ovarian Cancer Genesis
The National Cancer Institute estimates that more than 22,000 women will be diagnosed with ovarian cancer in 2016. Ovarian cancer is the fifth leading cause of cancer-related deaths among American women.

Abnormal cells in or near the ovaries can grow into a malignant tumor that can turn cancerous. Women who have reached menopause or who have a family history of ovarian cancer, and women with the BRCA1 or BRCA2 genetic mutations are most at risk for developing ovarian cancer.

Summary of Problem and Scope

Despite research and published studies, no current ovarian cancer screening tests are sensitive enough to “reliably screen for ovarian cancer without a high number of inaccurate results,” wrote the FDA. That dearth of results comes despite several companies marketing tests which claim to screen for ovarian cancer and detect it.

Abcodia Incorporated
The FDA referenced Abcodia Incorporated in its safety alert. That company began marketing its Risk of Ovarian Cancer Algorithm (ROCA) test in the United States. It claimed ROCA could screen for and detect ovarian cancer before symptoms appeared. The company claimed its test could increase the chance for survival. But the data failed to support the company’s claims.

Women and Doctors misled by False Claims

FDA voiced its concern that women and their physicians could be misled by claims of ovarian cancer screeners that can’t reliably screen. The agency said it doesn’t want women to “rely on inaccurate results to make treatment decisions.”

FDA wrote:
“Based on the FDA’s review of available clinical data from ovarian cancer screening trials and recommendations from healthcare professional societies and the U.S. Preventive Services Task Force, available data do not demonstrate that currently available ovarian cancer screening tests are accurate and reliable in screening asymptomatic women for early ovarian cancer.”

False Positive, False Negative

FDA also said some ovarian screening tests could present a false positive reading. Such women might undergo more medical tests and even unnecessary surgery. They might then experience complications related to both. In addition, test results might not show ovarian cancer even though cancer is present (a false-negative). That could lead women to delay or not seek surgery or other treatments for ovarian cancer.

“At this time (Sept. 7, 2016), the FDA is not aware of any valid scientific data to support the use of any test, including using a test cleared or approved by FDA for other uses, as a screening tool for ovarian cancer.”

Morcellator Use Questionable at Best

With such a powerful statement from the FDA, it is fair to ask whether power morcellators for hysterectomy should be used on any woman at this time.  When power morcellators are used on undetected cancer tissue, they can spread the disease and even make it much more lethal.

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Myomectomy Fibroids can trigger Morcellator Lawsuit

Myomectomy is the Morcellator Surgery Risksurgical removal of fibroids from the uterus. Myomectomy saves the uterus, and it can save a woman from undergoing a complete hysterectomy. Myomectomy is the preferred fibroid treatment for women who wish for pregnancy, because it can improve the chances of it.

Fibroids – according to womenshealth.gov – are muscular tumors that grow in the wall of the uterus (womb). Another term for fibroids is “leiomyoma”, or simply “myoma.” Fibroids may grow as a single tumor in the uterus, or they can grow in bunches, individually as small as a seed, or as big as a grapefruit. In rare cases they can grow even larger.

Cancerous Uterine Fibroids

Fibroids are usually benign, non cancerous. But when they are cancerous and that cancer is not detected, problems can result. When a power morcellator slices and dices cancerous fibroids and simultaneously vacuums them out of the uterus, the morcellator can spread the cancer with tragic results, leading to uterine cancer and perhaps other types of soft tissue cancer. When that happens, Morcellator Lawsuits are being filed across the country.

Surgical methods for Myomectomy (Web MD):

  • Hysteroscopy – a lighted viewing instrument inserted through the vagina and into the uterus.
  • Laparoscopy – a lighted viewing instrument used for one or more small abdomen incisions.
  • Laparotomy – a larger incision in the abdomen.

Myomectomy Method of choice depends on several factors:

• Fibroid size, location, numbers.
• Hysteroscopy to remove inner wall fibroids that haven’t grown deep into the uterine wall.
• Laparoscopy to remove fibroids, up to 2 in. (5.1 cm) across, growing on the outside of the uterus.
• Laparotomy to remove large or many fibroids, or fibroids grown deep into the uterine wall.
• To correct urinary or bowel problems without causing organ damage, laparotomy usually best.

Myomectomy Overview

Hysteroscopy is an outpatient procedure, while Laparoscopy may be an outpatient procedure or may require a one-day stay. Laparotomy requires an average stay of 1-4 days.

Recovery time depends on the myomectomy method. It can take from a few days to six weeks or more. :

Fibroid Recurrence

Fibroids return after surgery in 10 to 50 out of 100 women (according to Web MD), depending on the original fibroid problem. Larger and more numerous fibroids are most likely to recur.

Hysterectomy for Fibroids

In rare cases, a hysterectomy is needed when the surgery reveals that the uterus is too overgrown with fibroids for a safe myomectomy.

Related

•  WomensHealth.Gov: Uterine Fibroids Fact Sheet

•  Uterine Fibroids Health Center (Web MD)

•  Morcellator Lawsuit

•  Uterine Cancer Lawsuit

•  Morcellator Lawsuit Update

•  Morcellator a National Security Threat from FDA

•  American College of Obstetricians and Gynecologists (2008, reaffirmed 2012). Alternatives to hysterectomy in the management of leiomyomas. ACOG Practice Bulletin No. 96. Obstetrics and Gynecology, 112(2, Part 1): 387-399.

•  Parker WH (2012). Uterine fibroids. In JS Berek, ed., Berek and Novak’s Gynecology, 15th ed., pp. 438-469. Philadelphia: Lippincott Williams and Wilkins.

•  Practice Committee of the American Society for Reproductive Medicine, Society of Reproductive Surgeons (2008). Myomas and reproductive function. Fertility and Sterility, 90(3): S125

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Morcellator Hazards must be reported if Bill passes

Morcellator hazards morcellator uterine cancermust be reported if a new bill passes. Today, morcellator problems for women with undetected uterine cancer are rarely reported by doctors. Likewise for other dangerous medical devices such as transvaginal mesh or metal-on-metal hip or knee replacements. Sadly, medical professionals just don’t take the time, or don’t have the time, to report adverse medical device events as they occur. A new bill proposed last month may, however, change the whole game.

If the new bill becomes law, doctors would be required to report to the FDA potentially serious problems with medical devices they use.

The “Medical Device Guardian’s Act,” is being pushed by some members of Congress to help raise awareness of the risks of power morcellators and other hazardous medical devices.  Morcellator uterine cancer problems inspired the bill’s sponsors to change the law. A long warnings delay kept thousands of women from making informed decisions about whether or not to allow power morcellators to be used on them. Laparoscopic power morcellator alre often used for cyst removal or hysterectomy.

In 2014, the FDA belatedly called for a “black box warning” for power morcellators. The agency then announced that morcellators can spread a hard-to-detect uterine cancer during surgery.

 

FDA receives Delayed Reports

Though medical studies and literature had highlighted the risk of power morcellators since they were first used in the 1990s, the FDA didn’t receive any report of an adverse event until late 2013.  It took a medical professional, Dr. Amy Reed, to bring dangers of the morcellator to the agency, after a morcellator was used on her personally during a hysterectomy at a Boston hospital.

Dr. Amy Reed, Morcellator Cancer Victim

The Wall Street Journal reported that U.S. Reps. Mike Fitzpatrick (R., Pa.) and Louise Slaughter (D.,N.Y.) wrote in a letter to colleagues introducing the bill: “After that initial report from Amy, hundreds of other safety reports began to flow into the FDA.”

“In retrospect, it should not have fallen on patients to get the FDA’s attention,” the representatives said.  “[E]veryone in the chain of care” should be responsible for informing the FDA of medical device hazards.

The FDA now requires hospitals and device manufacturers to report deaths and serious injuries linked to medical devices to the agency’s database of adverse events. However, doctors are not legally mandated to inform the FDA of adverse events, though the agency encourages them to report and even accepts doctors’ reports by smartphone.

The medical device legislation proposed would add doctors and doctors’ offices to the list of mandated reporters. Bill sponsors also said the bill would protect doctors from having reports they file to the FDA used against them in civil cases. Doctors’ understandable aversion to litigation, has, of course, left some or most of them reluctant to file such reports; but it seems this caveat of the bill could open the door for a potentially troubling conundrum. Would any doctor who reports his or her involvement in an adverse medical device event then be categorically immune from any responsibility related to using the device?

Power Morcellator Problems

Doctors use power morcellators in tens of thousands of minimally invasive procedures yearly to remove benign growths known as fibroids; however, uterine cancers called sarcomas can also appear as benign fibroids that can’t be detected before surgery.  A morcellator used in such cases can spread malignancies – and other diseased tissues – inside the body, spread cancer and lead to worse outcomes.

In most cases, doctors and patients have learned only after the morcellator was used that a benign “fibroid” was in reality cancerous, after pathologists then tested the tissue.

The Government Accountability Office has since launched an investigation, and dozens of morcellator lawsuits have been filed.

J&J Morcellator Lawsuits Settled

Johnson & Johnson and Ethicon suspended sales of their power morcellators in April 2014, then withdrew them from the market in July 2014. The company has settled more than 100 legal claims and lawsuits tied to the morcellator’s cancer-spreading risk, according to attorney David Matthews, a plaintiff’s lawyer who handles medical device and pharmaceutical drug lawsuits.

A spokeswoman for J&J’s Ethicon division was quick to point out: “The resolution of these cases is not an admission of liability. (We) believe that Ethicon acted appropriately and responsibly at all times in relation to its morcellation devices. We will defend ourselves in remaining lawsuits.” The woman refused to give amounts on settled claims or to discuss their terms.

Morcellator Litigation Nationwide

Separate morcellation cases are pending against other morcellator makers nationwide, including more than 40 filed in a Los Angeles court against Karl Storz GmbH. That company has denied wrongdoing in court filings and did not respond to a request for a comment from the Wall Street Journal in June 2016.

Morcellator Hazards must be reported if Bill passes

Power morcellator problems have additionally revealed gaps in the U.S. system for tracking serious device risks.  In the congressional representatives’ letter that introduced the legislation, they noted the hospital that treated Dr. Reed also saw a patient “harmed by a morcellator one year earlier”, yet failed to inform the FDA.

The Wall Street Journal reported that Brigham and Women’s Hospital in Boston had confirmed two cases – Dr. Reed’s in 2013 and another woman’s in 2012 – in which a power morcellator spread cancer. Hospital officials, however, according to a Brigham spokeswoman, had determined these two cases weren’t reportable because the “device functioned as expected and was used in the way it was intended, although with unintended and tragic consequence.” The woman added that Brigham has since fully reported both cases.

FDA admits Limitations

Still, the bill wouldn’t be a cure-all, the FDA intimated in a statement in June 2016 that the bill would not solve device reporting problems. The agency would not comment on pending legislation, but did say the medical device reporting system has “important limitations.”

The agency is now planning a national evaluation system that would use data generated during patient care to identify safety issues more quickly. The FDA said it needs congressional and industry support to “build this system.”

 

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Morcellator Lawsuit Settlements

Johnson & Johnson Hysterectomy Sarcoma Attorneyis moving to settle lawsuits filed by women who say J&J’s power morcellators spread undetected uterine cancer, according to The Wall Street Journal. J&J and its Ethicon division pulled the devices in 2014 following reports which said power morcellators spread uterine cancer when used for hysterectomy or fibroid removal.

100 Morcellator Cases

An estimated 100 cases have either been filed or prepared for lawsuits against J&J and Ethicon, which enjoyed the lion’s share of laparoscopic power morcellator sales. Power morcellator cases have been consolidated in Kansas City, Kan., federal court, before Judge Kathryn H. Vratil. Of the roughly 100 claims, J&J has settled nearly 70 over the past few months, according to the Wall Street Journal.

WSJ estimated that settlements so far have ranged from $100,000 to roughly $1 million, according to a WSJ source who claimed knowledge of resolved cases.

Morcellator Lawyer

David Matthews, a plaintiff’s lawyer handling power morcellator cases, said the range of settlement amounts reported by WSJ seems low considering the seriousness of the injuries.

“If the amounts reported are right, many of the cases that have settled must have had significant issues. You would tend to think that women who have died or are dying from morcellator injuries would not settle for the small amounts we have seen reported. But it’s always awfully hard to make any generalizations regarding settlement amounts. We don’t know what problems or issues such and such a case may have had to settle for whatever amount is reported. They call these mass torts, but there is never anything ‘en mass’ about them. Every case is always unique.”

Failure to Warn

Women suing J&J underwent hysterectomies or uterine fibroid removal in which surgeons used power morcellators. The women say J&J and Ethicon failed to warn them about the risk that the devices could antagonize and spread undiagnosed uterine cancer, making it more difficult to treat. Several plaintiffs have died before or after the lawsuits were filed; hence, morcellator attorneys are trying to accelerate the litigation to allow clients their chance to air their case in court.

Power Morcellators

Power morcellators are electric-powered devices with blades that allow surgeons to slice up large pieces of tissue like the uterus or fibroids in order to remove them through small incisions in the abdomen. This “minimally invasive” surgery is supposed to allow for quicker healing time, less blood loss, fewer complications.

Morcellators pulled by J&J

Laparoscopic power morcellators made by Ethicon and several other companies became controversial in 2014 after the FDA released a warning which said 1/350 women had undiagnosed uterine cancer that could be spread by morcellation. One type of cancer, leiomyosarcoma, is especially deadly when morcellated.

After the 2014 FDA warning, J&J, which had the largest percentage of the market, pulled its morcellator devices.

Morcellator Lawsuits

Morcellator lawsuits against J&J and Ethicon claim the devices are defective and that the company knew about the chance of spreading cancer yet failed to warn the public. J&J previously told the Wall Street Journal that its morcellators “have always included cautions in their instructions for use about the potential spread of malignant (or suspected malignant) tissue.”

Morcellator Lawsuit Settlements

Regardless of J&J’s pronouncement that it has always warned of morcellators’ spreading potentially malignant cancer, according to Mr. Matthews, J&J is already in talks to settle more of its morcellator lawsuits, including those it faces in state courts throughout the country.

Free Legal Consultation

If you or a loved one has been diagnosed with uterine cancer or  leiomyosarcoma after undergoing hysterectomy or fibroid removal with a laparoscopic power morcellator, contact  an experienced Morcellator Lawyer for a free legal consultation regarding a potential Morcellator Lawsuit.

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Morcellator National Security Threat

A surgeon whosenoorchashm and reed wife’s cancer was morcellated and hence spread and made more aggressive, has said the morcellator represents a national security threat from the FDA.  The surgeon said this threat is greater than the one from [so-called] ISIS.  He also said that gynecologists are corrupting basic surgical principles  by using  morcellators on fibroids without first screening them for cancer.

Update:  Doctor who denounced Morcellator dies. More

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