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Morcellation Media Monitoring 08/31/2015
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New Morcellator Lawsuit Filed by South Carolina Widower
Aug 27, 2015 | The Legal Herald
By Laurence P. Banville
Ethicon, a subdivision of Johnson & Johnson, is the manufacturer of the Gynecare Morcellex, a power morcellator. Power morcellators are surgical instruments that are used in gynecological laparoscopic surgeries such as hysterectomies and myomectomies. The U.S. Food and Drug Administration first approved the power morcellator in 1991. This approval came through the Center for Devices and Radiological Health under an act called a 501(k). Under the 501(k) a device does not have to go through rigorous safety testing but can be approved by showing that it is “substantially equivalent” to a previously approved device. -
Can Hysterectomy Cause Uterine Cancer Spread?
Aug 27, 2015 | Top Class Actions
By Shezad Malik MD JD
Short answer, YES. Minimally invasive or laparoscopic removal of the uterus, know as hysterectomy is one of the most common medical procedures performed in the United States. And according to some experts, the procedure may be over-utilized for treatment of fibroids or benign tumors of the uterus. During the surgery, many doctors remove the uterus in pieces using a mechanical grinding or chopping device known as a power morcellator. -
Morcellator Cancer Lawsuit Filed From Death Bed
Aug 27, 2015 | Top Class Actions
By Joanna Szabo
From her death bed, a 43-year-old New York woman is suing her oncologist for malpractice, alleging he used a controversial medical device that caused cancer cells to spread throughout her internal organs. Plaintiff Viviana R., a Stage 4 cancer patient, underwent a minimally invasive hysterectomy last year at a hospital in New Jersey. Hysterectomy is the surgical removal of the uterus and/or other surrounding structures, and Viviana’s oncologist, Dr. Howard Jones, used a controversial power morcellator to complete the surgery. -
Georgia Morcellator Lawsuit Alleges Morcellator Spread Malignent Cancer to Abdominal Wall
Aug 28, 2015 | KSWO-TV 7
By Sean Tracey
Tracey & Fox recently reported that Johnson & Johnson has had another lawsuit filed against it’s subdivision, Ethicon. Ethicon Endosurgery, Inc is the company that is responsible for designing, researching, manufacturing, testing, promoting, and selling several power morcellators, including the Gynecare Morcellex Tissue Morcellator, Morcellex Sigma Tissue Morcellator System, and the Gynecare X-tract Tissue Morcellator. These morcellators are surgical tools which are used in laparoscopic surgeries. During the laparoscopic procedures, the morcellator is inserted into the abdominal cavity via small incisions. Once it has been inserted, the morcellator is used to slice up tissue that is intended for removal so that small pieces can be taken out through the incision.
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New Morcellator Lawsuit Filed by South Carolina Widower
Aug 27, 2015 | The Legal Herald
By Laurence P. Banville
Ethicon, a subdivision of Johnson & Johnson, is the manufacturer of the Gynecare Morcellex, a power morcellator. Power morcellators are surgical instruments that are used in gynecological laparoscopic surgeries such as hysterectomies and myomectomies.
The U.S. Food and Drug Administration first approved the power morcellator in 1991. This approval came through the Center for Devices and Radiological Health under an act called a 501(k). Under the 501(k) a device does not have to go through rigorous safety testing but can be approved by showing that it is “substantially equivalent” to a previously approved device.
In order for a device to be considered substantially equivalent it has to have the same intended use as the original and have the same technological characteristics. The Gynecare Morcellex was approved for sale and use under the 501(k) in 2006 and 2010.
In 2014, the FDA issued a warning to the medical community regarding the use of the power morcellator during gynecological surgeries, indicating that the morcellator could spread undetected malignant cancer cells to other areas of the body. It also gave the morcellator a “black box warning” which reads, “The FDA warns that uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer, and decrease long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.”
South Carolina Lawsuit
The lawsuit, filed on February 3rd, 2015 in the United States District Court for the District of South Carolina Greenville Division under case number 6:15-cv-00516-MGL, alleges that the use of the Gynecare Morcellex caused dissemination of undiagnosed leiomyosarcoma which resulted in the death of a South Carolina woman. Her widower has pursued a lawsuit on her behalf.
On October 2nd, 2012, the deceased plaintiff had a total laparoscopic robotic hysterectomy and cystoscopy performed to remove uterine fibroids. The surgeon used a morcellator to remove three uterine fibroids which were then sent to a pathologist. Despite having had pre-surgical screenings for cancer which returned with no significant findings, the pathologist determined that one of the fibroids contained a form of malignant cancer, leiomyosarcoma.
The lawsuit alleges that the “leiomyosarcoma cancer tissue would have remained encapsulated but for the tissue shredding and dissemination of the Gynecare Morecellex. The device, in cutting and shredding the uterine fibroid, ruptured the capsule containing the cancerous tissue and spread the shredded tissue in the abdominal cavity.” In 2013, the plaintiff was found to have cancer cells consistent with leiomyosarcoma in areas around her vaginal cuff, her ureters, and throughout the omentum. After her diagnosis, she pursued aggressive treatment for her leiomyosarcoma but, unfortunately, passed away on September 25th, 2014, after cancer spread to her hepatic lobe.
This lawsuit is one of many filed since the FDA released their warning. For questions regarding this press release or questions regarding the pending litigation, contact Laurence Banville Esq. at 917-633-4808.
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Can Hysterectomy Cause Uterine Cancer Spread?
Aug 27, 2015 | Top Class Actions
By Shezad Malik MD JD
Short answer, YES. Minimally invasive or laparoscopic removal of the uterus, know as hysterectomy is one of the most common medical procedures performed in the United States. And according to some experts, the procedure may be over-utilized for treatment of fibroids or benign tumors of the uterus.
During the surgery, many doctors remove the uterus in pieces using a mechanical grinding or chopping device known as a power morcellator.
Recently, many product liability and personal injury lawsuits being filed against the manufacturers of power morcellators. The injured women claim that patients and doctors should have been warned about the risks associated with use of the medical devices during minimally invasive, laparoscopic hysterectomies.
What Are Power Morcellators?
Power morcellators are medical devices that are used during laparoscopic hysterectomy and myomectomy (fibroid removal) procedures. The device allows the surgeon to grind up the uterus or uterine fibroids and remove the tissue through a small incision in the abdomen. The medical device is used during minimally invasive surgery, and reduces recovery time, scarring and speeds up recovery time.Morcellator can cause Uterine Cancer spreadAccording to medical experts and the FDA, about one out of every 350 women undergoing a laparoscopic hysterectomy with morcellation may have undiagnosed sarcoma, which doctors are unable to detect before the surgery. Undiagnosed uterine can be a lethal form of cancer, with poor life expectancy and treatment options.There is no bullet proof way for doctors to diagnose the uterine cancer before using the morcellator devices to grind up the uterus. Because of this, the FDA strongly urged doctors to avoid using the devices for laparoscopic hysterectomy or myomectomy procedures in April 2014. The FDA issued a BLACK BOX WARNING against the use of these devices in November 2014.Power morcellators spread this undiagnosed leiomyosarcoma, endometrial stromal sarcoma or other cancer throughout the pelvis and abdomen during the grinding process, leading to rapid upstaging of the cancer and reducing the risk of long-term survival. As this risk becomes known, many doctors have stopped the use of power morcellators over the past year.Morcellators Approved Under the 510(k) Program
The controversial 510(k) program allows medical devices to be approved without pre-market testing requirements. Under the program, the manufacturer just needs to show that the devices are “substantially equivalent” to devices already on the market. Power morcellators were approved under the 510(k) process without any safety testing.
J&J Ethicon Morcellator Recall
All Ethicon power morcellators were recalled by the manufacturer, earlier last year. J&J, acknowledged that the devices pose an unreasonable risk of disseminating uterine cancer. Ethicon, a J&J subsidiary requested that hospitals voluntarily return all laparoscopic surgery morcellators. The company, noted that it will no longer sell the devices since there is no way to make them safe.
FDA Morcellator Black Box Warning
The FDA announced November 24, 2014 that it is adding a black box warning to uterine morcellator devices that remain on the market. A BLACK BOX WARNING, is the strongest warning that can be placed on any medical device. Patients, doctors and hospitals are now on notice of the potential danger of increased uterine cancer spread risk associated with the use of these devices.
Furthermore, the FDA announced that power morcellators should not be used with women near menopause or post-menopausal, or in women who could have tissue removed through the vagina or via a small incision.
This contraindication prohibits the use of the devices in the vast majority of women who undergo laparoscopic or vaginal uterine morcellation procedures.
Power Morcellators Under the Gun
Power morcellators have been under under fire since the well-publicized case of anesthesiologist Amy Reed, who underwent a hysterectomy, for fibroid removal in October 2013. Dr Reed, then discovered that power morcellation had spread an undiagnosed uterine leiomyosarcoma.
The FDA’s warnings last year triggered a widescale retreat from tissue morcellation. Johnson & Johnson voluntarily withdrew its morcellators from the market because of cancer “uncertainty.”
Power Morcellator Cancer Litigation
Many complaints have been filed in the federal court system nationwide. These women were diagnosed with the spread of leiomyosarcoma, endometrial stromal sarcoma or other cancers following uterine fibroid surgery.
All of the lawsuits filed against manufacturers of these devices claim that hysterectomy morcellators are unreasonably dangerous and that information about the risk of uterine cancer being spread was withheld from the patients and doctors.
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Morcellator Cancer Lawsuit Filed From Death Bed
Aug 27, 2015 | Top Class Actions
By Joanna Szabo
From her death bed, a 43-year-old New York woman is suing her oncologist for malpractice, alleging he used a controversial medical device that caused cancer cells to spread throughout her internal organs.
Plaintiff Viviana R., a Stage 4 cancer patient, underwent a minimally invasive hysterectomy last year at a hospital in New Jersey. Hysterectomy is the surgical removal of the uterus and/or other surrounding structures, and Viviana’s oncologist, Dr. Howard Jones, used a controversial power morcellator to complete the surgery.
Viviana alleges that this device directly caused her to develop Stage 4 cancer, and she is filing a morcellator lawsuit from her death bed in response.
According the power morcellator lawsuit, Jones used the medical device to cut and tear tissue in Viviana’s uterus so a large uterine fibroid could be removed. Mere weeks after the procedure in October 2014, Viviana was diagnosed with incurable Stage 4 leiomyosarcoma cancer.
Viviana’s morcellator cancer lawsuit has been filed against her doctors, the hospital, and the device maker Karl Storz Endoscopy.
Viviana may run into some issues with her morcellator lawsuit, in that it is apparently very difficult to detect sarcoma cells in a biopsy, meaning that had her doctor performed a pre-operative biopsy, he still may not have detected the cancer. This information may make it difficult to declare that her doctor’s use of a power morcellator directly caused morcellator cancer.
Controversy Over Use of Power Morcellators
The power morcellator that was used in Viviana’s surgery is not new to the medical community, and was approved in 1991 to remove uterine fibroids. The device makes extremely small incisions, which in turn help patients recover quicker and easier.
In recent years, however, the power morcellator has come under some heavy scrutiny. In April 2014, the FDA released a safety alert against morcellators. In the statement, the agency acknowledged that the power morcellator can potentially spread undetected cancer cells.
In the process of removing a structure such as uterine fibroids, a power morcellator can cut up tissue fragments that, unknown to the doctor, are cancerous. These tissue fragments, once cut, are left behind as the fibroid or other structure is removed, and can spread from there to other parts of the body.
Once this information came to light, the government began discouraging doctors from the use of morcellators. They also encouraged medical professionals to discuss the risks and benefits of such devices with their patients before operating.
In response to the FDA’s warnings, Ethicon pulled the morcellator device off the market. Ethicon is a division of the giant Johnson & Johnson company, and is the largest manufacturer of power morcellators.
Despite these warnings and the morcellator manufacturer’s response, the power morcellator lawsuit alleges that Viviana’s doctor continued using the tool. Viviana claims that her doctor did not perform a pre-operative biopsy, nor did he discuss the risks of using a power morcellator, as the FDA advised..
Since Viviana’s terminal leiomyosarcoma diagnosis, the FDA has reassessed the risk of cancer for women undergoing a fibroid removal surgery or hysterectomy. The agency recently increased the risk of undetected aggressive cancer cells after a hysterectomy for fibroids from one in 500 to one 352.
Experts say that, given the FDA warnings and various manufacturers’ retractions of morcellator devices, it is probably best to avoid using a power morcellation device in surgical procedures.
Two dozen morcellator lawsuits have already been filed in the country for morcellator cancer. If you or someone you know has undergone a surgery where a doctor has used a power morcellator and have since contracted cancer, you may be able to file a morcellator cancer lawsuit.
The Power Morcellator Cancer Lawsuit is Case No. 2:15-cv-05704-JLL-JAD, in the U.S. District Court for the District of New Jersey.
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Georgia Morcellator Lawsuit Alleges Morcellator Spread Malignent Cancer to Abdominal Wall
Aug 28, 2015 | KSWO-TV 7
By Sean Tracey
August 28, 2015 – /PressAdvantage/ – Tracey & Fox recently reported that Johnson & Johnson has had another lawsuit filed against it’s subdivision, Ethicon. Ethicon Endosurgery, Inc is the company that is responsible for designing, researching, manufacturing, testing, promoting, and selling several power morcellators, including the Gynecare Morcellex Tissue Morcellator, Morcellex Sigma Tissue Morcellator System, and the Gynecare X-tract Tissue Morcellator.
These morcellators are surgical tools which are used in laparoscopic surgeries. During the laparoscopic procedures, the morcellator is inserted into the abdominal cavity via small incisions. Once it has been inserted, the morcellator is used to slice up tissue that is intended for removal so that small pieces can be taken out through the incision.
Since the power morcellator was first approved for use by the U.S. Food and Drug Administration in 1991, it has been used in countless gynecological surgeries. Most often, the morcellator is used during hysterectomies and myomectomies where uterine fibroids are present.
In 2014, a study, the “Uterine Pathology in Women Undergoing Minimally Invasive Hysterectomy Using Morcellation” was released. In the study, it was noted that 1 out of 370 women has some form of uterine cancer. This is dangerous for women whose surgeons use a morcellator because as the morcellator shreds the tissue, it is suspected that it spreads cells throughout other areas of the abdominal cavity, including malignant cancer cells.
On April 7th, 2015, a new lawsuit was filed against Ethicon, in the United States District Court Northern District of Georgia Atlanta Division under case number 1:15-cv-01046-ODE. The plaintiff, a women residing in Sandy Springs, Georgia, underwent a total laparoscopic hysterectomy at Piedmont Hospital in Atlanta, Georgia, on January 20th, 2011. The plaintiff’s surgeon used a Gynecare Tissue Morcellator. Prior to her surgery, the plaintiff underwent testing which showed no evidence of metastatic cancer. Biopsies taken during the surgery revealed the presence of malignant uterine cancer – both endometrial stromal sarcoma and leiomyosarcoma. She was treated and believed herself to be cancer free.
On April 10th, 2013, the plaintiff presented to the hospital for evaluation of an abdominal wall mass. Biopsies of that mass, as well as a surgical debulking, were performed and it was determined that she had a recurrence of metastatic endometrial sarcoma.
The lawsuit alleges that because of the use of the power morcellator, the malignant cancer cells were spread throughout the abdominal cavity resulting in the abdominal wall mass which involves the pelvis and left anterior abdominal wall through the peritoneum.
In July 2015, one of the first morcellator lawsuits filed settled for an undisclosed amount.
For more information about this press release contact Tracey & Fox at (713) 322-5420.
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