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Morcellation Media Monitoring 12/24/2015
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Congressman: FDA should probe ROC morcellation deaths
Dec 23, 2015 | Rochester Democrat & Chronicle
By Patti Singer
A Pennsylvania congressman has called for the Food and Drug Administration to investigate what, if any, reporting Rochester General and Strong Memorial hospitals made about the deaths of three Rochester-area women after a power morcellator was used during their gynecologic surgery. -
Morcellation Lawsuit: Device Caused Pelvic Masses, Requiring Several Surgeries
Dec 22, 2015 | Top Class Actions
By Ashley Vanover
A growing number of product liability lawsuits are being filed over the use of power morcellators, medical devices used during hysterectomy and fibroid removal surgery, alleging that they cause the spread of cancer. -
Widower Sues J&J for Wife’s Power Morcellator Death
Dec 24, 2015 | Top Class Actions
By Amanda Antell
Johnson & Johnson is facing a new power morcellator lawsuit from a Florida man, who claims that his wife died as a direct result of their surgical device.
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Congressman: FDA should probe ROC morcellation deaths
Dec 23, 2015 | Rochester Democrat & Chronicle
By Patti Singer
A Pennsylvania congressman has called for the Food and Drug Administration to investigate what, if any, reporting Rochester General and Strong Memorial hospitals made about the deaths of three Rochester-area women after a power morcellator was used during their gynecologic surgery.
Rep. Mike Fitzpatrick sent a letter Dec. 18 to the FDA’s Office of Criminal Investigations,asking director George Karavetsos to find out what the hospitals said happened in the deaths of Barbara Leary, Linda Interlichia and Brenda Leuzzi.
Leary underwent power morcellation as part of minimally invasive surgery for presumed fibroids in March 2009 at Rochester General and died in September 2013. Interlichia underwent the procedure at Rochester General in October 2013 and died in October 2014. Leuzzi underwent the procedure at the University of Rochester Medical Center’s Strong Memorial Hospital in September 2012 and died in October 2014.
“For me personally, it’s bittersweet,” widower Jim Leary said of Fitzpatrick’s request. “I’m always thankful when anybody does anything to uncover more information or investigate. I’m happy Congressman Fitzpatrick is taking the lead in this. He seems to be very direct in asking, 'Were rules, regulations and policies in place and if not, why not?'
“The sad part of it is if these questions come to be true, I’m very disappointed that if Rochester General had a requirement to fulfill and if they didn’t, why didn’t they?” Leary said. “Same with Strong. They’re two upstanding hospitals known nationally for their health care. It would be very, very disappointing to me if they were required to do something federally and for whatever reason failed to do it.”
In separate statements, the hospitals claimed no violation of FDA regulations.
Fitzpatrick’s letter states that under mandatory Medical Device Reporting regulations,hospitals are required to report to the FDA within 10 days any information and “reasonably suggests that a device has or may have caused or contributed to the death of a patient of your facility.” The regulations include other reporting mandates by hospitals and by device manufacturers. The section cited, 21 Code of Federal Regulations 803, has undergone amendments. According to the website, an update was issued in 2013.
A power morcellator is a high-speed device that was used in minimally invasive gynecologic surgery, such as to remove suspected fibroids or for a hysterectomy. The only way to know for sure that a fibroid is benign is by a pathology report after surgery. Therefore, the blades used to shred the tissue and make it easier to remove through the small incisions used in minimally invasive surgery could be spreading potentially cancerous tissue.
Fitzpatrick basically asks Karavetsos to find out what the hospitals reported or why they didn't report. Fitzpatrick also includes the case of Erica Kaitz, who underwent power morcellation as part of gynecologic surgery in 2012 at Boston’s Brigham and Women’s Hospital.
In response to questions from the Democrat and Chronicle, Strong and Rochester General issued statements.
From URMC associate vice president for communications Christopher DiFrancesco:
“Like many hospitals across the country, Strong Memorial Hospital did not initially report its 2012 morcellation case to the FDA because it did not appear to meet the criteria for medical device reporting. Historically, FDA required device user facilities to report information when there is a patient death or serious illness or injury of a patient, caused or contributed to by instances of device failure, malfunction, improper or inadequate device design, manufacture, labeling or user error. (Emphasis by URMC.) Based on our interpretation of this language at the time, it did not fit the definition of a device 'failure.' The device functioned as expected and was used in the way it was intended, although with unintended and tragic consequences.
"In November 2014, FDA issued guidance clarifying that these cases were considered by the FDA to be a 'serious injury' that should be reported. We didn’t formally report our case at that time because the FDA was already aware of it from media reports. Earlier this month we provided the FDA with additional information about the case and a point of contact in case they need more details.
"In hindsight, while there wasn’t a regulatory obligation to report the case in 2012, we wish that we had. It might have helped the FDA understand the scope of the problem sooner so they could take steps to protect other patients. That’s the ultimate goal of the reporting system, and what all of us want as health care providers.
"This incident has prompted us to lower our threshold for reporting concerns to the FDA regarding medical devices.”
From Rochester Regional Health Chief Medical Officer Dr. Robert Mayo:
“Our privacy policy dictates that we cannot comment on specific patients.
"We were just recently made aware of the letter to the FDA, and are carefully investigating its content. That said, we follow the FDA’s policies and procedures for reporting medical device-related deaths and serious injuries and, as a result, we do report injuries that have been deemed device-related.
"We are not aware of any current or past enforcement actions related to reporting requirements under 21 CFR 803. We’ll continue to work with the FDA to ensure compliance and always welcome the administration’s feedback. Patient safety is our top priority, and our relationship with the FDA helps ensure the highest quality care.
"As you know, related to laparoscopic power morcellators specifically, our system discontinued use more than a year ago.”
Power morcellation was considered a common part of minimally invasive laparoscopic hysterectomy until about two years ago. In late 2013, Dr. Hooman Noorchashm, a cardiothoracic surgeon then in Boston, began a campaign to stop the use of power morcellators after his wife, Dr. Amy Reed, underwent minimally invasive surgery for a hysterectomy, and the morcellator spread a previously undetected cancer.
Over the next few months, the FDA issued a warning about the device but did not ban power morcellation but a major manufacturer, Johnson & Johnson, recalled its device. In the summer of 2014, the FDA held hearings about the device and the research known to date.
Noorchashm has said the gynecological surgeons are the only ones who perform morcellation. He said other surgeons who use minimally invasive techniques extend the incision to accommodate the size of tissue that needs to be extracted.
URMC allows tissue from minimally invasive gynecologic surgery to be placed in a containment bag and cut by a scalpel or scissors. When the tissue is small enough, the bag is removed.
Other members of Congress have asked the FDA to look into who knew what about morcellation and when they knew it. There have been reports that the medical community knew about adverse events for several years.
Sens. Charles Schumer and Kirsten Gillibrand had written to the FDA. Rep. Louise Slaughter, D-Fairport, commissioned a study from the Government Accountablity Office that a spokesman said should be completed in about a year.
Even though Fitzpatrick’s letter to the FDA uses the word “request,” it seems the strongest to date and takes the case up the ladder. Fitzpatrick became involved when Noorchashm and Reed moved to the Republican’s district.
“…The sad fact is this issue stretches across district lines and impacts hundreds of women and families,” Fitzpatrick wrote in an email. “I hope to hear back quickly that the FDA Office of Criminal Investigations will take up the request because it appears, based on in-depth reporting, that multiple institutions around the country failed to report serious injuries and deaths related to the power morcellator as required by federal law.”
Leary said Fitzpatrick’s letter should lead to more information.
“Tragic things happen but we don’t understand why. If there’s a problem and we need to correct the problem and save lives, then it’s all for the good.”
At the same time, it brings back a terribly painful part of his life.
“The end result is to help other people,” he said. “It’s like with organ donors. You lose a loved one but because they donate organs you save the life of several individuals. I look at it this way. I’ve lost Barb. If I can help save the lives of many other women across the United States, then to rehash this and to go through the heartbreak of the memories is worth it.”
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Morcellation Lawsuit: Device Caused Pelvic Masses, Requiring Several Surgeries
Dec 22, 2015 | Top Class Actions
By Ashley Vanover
A growing number of product liability lawsuits are being filed over the use of power morcellators, medical devices used during hysterectomy and fibroid removal surgery, alleging that they cause the spread of cancer.
One such power morcellator lawsuit, filed by a Southern California woman, claims that morcellator device manufacturer Ethicon (a subsidiary of Johnson & Johnson) was aware that morcellators could disseminate and upstage parasitic fibroid cells into other parts of women’s bodies.
Plaintiff Deborah E. underwent a laparoscopic hysterectomy in September 2013 for the treatment of uterine fibroids. During this procedure, an Ethicon Gynecare power morcellator was used to remove tissue.
In April 2015, Deborah reported to her doctor with abdominal pain and it was discovered through an ultrasound and biopsy that she had developed multiple abdominal pelvic masses and lesions in her liver. She was advised she would require long term hormonal therapy and possible surgery to take out the masses.
According to the morcellation lawsuit, Deborah was admitted to the hospital at a frail 89 pounds later that year and it was further determined that her masses had grown in size, additional fibroids were detected and her bowel had been displaced into her upper abdomen, causing severe distention and pain.
Due to the severity of Deborah’s masses she will be forced to undergo at least 5 more major surgeries in the coming weeks in order to combat the damage allegedly caused by the power morcellator device.
Deborah is seeking to add her power morcellator lawsuit to the multidistrict litigation against Ethicon.
What is Power Morcellation?
Gynecologists use power morcellators when they perform laparoscopic procedures, such as a hysterectomy or a myomectomy in which they remove uterine fibroids.
These instruments have rotating blades that break large tissue masses into small fragments. Broken down tissues are then vacuumed away and out of the body.
The inherent risk of laparoscopic power morcellation is the dissemination of the broken-up tissue. Benign tissue can become implanted on abdominal structures and organs, resulting in conditions such as fibroids, endometriosis, and adenomyosis, potentially requiring further surgery.
FDA Discourages Use of Laparoscopic Power Morcellator
The FDA issued a safety warning in April discouraging doctors from using laparoscopic power morcellators to remove uterine fibroids because of the risk of spreading undiagnosed cancer and other injuries throughout the abdominal cavity. Shortly after, Johnson & Johnson suspended sales of its laparoscopic power morcellators sold by its Ethicon division.
According to the FDA, doctors use power morcellators in thousands of hysterectomies a year and there is a significant risk for cancer development or other complications after morcellation surgery.
A number of additional treatment options are available for women with uterine fibroids, including traditional surgical hysterectomy (performed either vaginally or abdominally) and myomectomy, and laparoscopic hysterectomy and myomectomy without morcellation, as well as other non-surgical options.
Morcellation Lawsuits
A growing number of morcellation lawsuits stem from the use of laparoscopic power morcellators in hysterectomies and other gynecological surgeries. Some doctors are still performing hysterectomies and uterine fibroid removals via uterine morcellation, despite the FDA warning.
The Ethicon Power Morcellation Lawsuit is Case No.8:15-cv-01902-CJC-JCG, in the U.S. District Court for the Central District of California, Southern Division.
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Widower Sues J&J for Wife’s Power Morcellator Death
Dec 24, 2015 | Top Class Actions
By Amanda Antell
Johnson & Johnson is facing a new power morcellator lawsuit from a Florida man, who claims that his wife died as a direct result of their surgical device.
The grieving husband alleges his wife died due to an aggressive form of cancer known as leiomyosarcoma, which was released from a dormant uterine sarcoma due to the Gynecare LPM power morcellator.
The company’s subsidiary and Gynecare LPM manufacturer, Ethicon Inc., is facing the brunt of the product liability claims from plaintiff Gary H. The decedent, Sara R., had underwent a laparoscopic hysterectomy procedure on Jan. 16, 2001 to remove unwanted uterine fibroids.
Even though the procedure was successful, it was not long after that Sara was diagnosed with uterine cancer. She eventually succumbed to the disease on Jan. 14, 2014, leaving a permanent absence in her husband’s life.
Several months after her death, Gary had been notified of an important FDA announcement regarding the use of power morcellator devices during gynecological laparoscopic surgeries.
Ideally the Gynecare LPM power morcellator would have provided a safe and efficient method for uterine fibroid removal, but had caused fatal complications instead.
Gary insists that his wife never would have opted to have the Gynecare LPM device used during her surgery if she had known the risk of power morcellator cancer. Furthermore, Gary alleges that Johnson & Johnson and Ethicon failed to notify his wife or her surgeons of the potential dangers of power morcellators spreading undetected uterine sarcoma.
So for being allegedly responsible for manufacturing, selling, distributing, and marketing a dangerous medical device, Gary is suing Johnson & Johnson. The charges include: negligence, false advertising, concealing information, and misrepresenting a product.
Overview of Power Morcellator Complications
A power morcellator is a surgical tool composed of tiny rotating blades that cut through uterine fibroids for easy removal. These devices are used for these types of surgeries often because it is less invasive and requires less hospital recovery time.
In April 2014 the FDA announced that power morcellators could potentially release dormant cancer cells in women who have undiscovered uterine sarcoma, estimating that one in 350 women may have undiagnosed cancer cells.
The agency went on further to say that there is currently no diagnostic method available, to predetermine if the woman has uterine sarcoma prior to morcellation surgery.
When a power morcellator is used in hysterectomies or other laparoscopic surgeries, it could potentially rupture uterine sarcoma sacs. Once these areas are opened, the cancer cells can spread and quickly progress inside the patients, often leading to latent stage diagnoses.
The Power Morcellator Cancer Lawsuit is Case No. 6:15-cv-01924-GAP-TBS, in the U.S. District Court of Middle Florida, Orlando Division.
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