Preview Newsletter
Morcellation Media Monitoring 05/05/2016
-
Does Power Morcellation Cause Uterine Cancer?
May 3, 2016 | Top Class Actions
By Joanna Szabo
Power morcellation is sometimes used during minimally invasive hysterectomies or myomectomies, but the device has raised concerns in recent years with its link to uterine cancer. -
FDA Probes Cancer Deaths Following Power Morcellator Use
May 5, 2016 | Top Class Actions
By Tamara Burns
The U.S. Food and Drug Administration has investigated cancer deaths associated with power morcellator devices.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Morcellation
Full Text of Stories Below
-
Does Power Morcellation Cause Uterine Cancer?
May 3, 2016 | Top Class Actions
By Joanna Szabo
Power morcellation is sometimes used during minimally invasive hysterectomies or myomectomies, but the device has raised concerns in recent years with its link to uterine cancer.
Power morcellation has been in use across the United States since it was initially approved by the U.S. Food and Drug Administration in 1991.
Power morcellation is used druing a laparosccopic surgical procedure forhysterectomy or fibroid removal that cuts unwanted uterine tissue or fibroids into smaller, easier pieces to remove through a small surgical incision.
However, this process may cause women to develop serious or even life-threatening morcellator side effects. Reports suggest that power morcellator devices, in cutting up uterine fibroids, may put patients at a risk for more rapid growth of uterine cancer.
This can happen if a patient undergoing hysterectomy or myomectomy surgery already has hidden uterine cancer that they do not know about. Power morcellation, while cutting up uterine fibroids, may spread those fibroid tissues into tiny, cancerous pieces that can spread throughout the body spread uterine cancer.
There is no evidence that power morcellation actually causes uterine cancer. Instead, patients who already have uterine cancer that undergo the power morcellation process may develop uterine cancer much more rapidly than they otherwise would have when their latent cancer is spread. This can increase a patient’s risk, because the cancer may become more serious very quickly.
In April 2014, the FDA released a safety alert about the use of power morcellation. The statement acknowledged that power morcellation to remove fibroids in the uterus could potentially spread cancer cells previously undetected by the doctor, placing patients at a more serious risk.
The FDA reports that about 1 in 350 women who go through power morcellation surgery have this dangerous, undetected uterine cancer.
Surgical procedures that often use a laparoscopic power morcellator include the following:
-Robotic hysterectomy
Morcellation hysterectomy
Laparoscopic hysterectomy
Fibroid removal surgery
-Myomectomy
Other power morcellation side effects include noncancerous fibroids causing prolonged menstrual bleeding or pelvic pain.
Power Morcellation Lawsuits
Some of the women who have been diagnosed with uterine cancer after undergoing power morcellation during a surgery such as a hysterectomy or myomectomy claim that their cancer would not have been so serious had a power morcellator not been used.
Though the lawsuits do not suggest that power morcellation actually caused the cancer, they do claim that the plaintiffs would have not have agreed to the procedure. Instead, the plaintiffs claim that they would have chosen an alternative surgical method and thus avoided the extent of the cancer had they been adequately warned of these risks.
Essentially, these lawsuits allege that the malignant uterine cancer tissue was spread and worsened because of power morcellation, ultimately worsening a patient’s chance of treatment survival.
Power morcellator lawsuits claim that morcellator manufacturers, including Ethicon, either knew or should have known about this serious and even life-threatening risk associated with their device.
If you or someone you know has been diagnosed with cancer after a hysterectomy or myomectomy fibroid surgery using a power morcellator, you may be able to file a morcellation lawsuit.
-
FDA Probes Cancer Deaths Following Power Morcellator Use
May 5, 2016 | Top Class Actions
By Tamara Burns
The U.S. Food and Drug Administration has investigated cancer deaths associated with power morcellator devices.
The investigations focused on power morcellator devices used during minimally invasive surgeries performed at various hospitals throughout the U.S.
Brigham & Women’s Hospital, Rochester General Hospital and University of Rochester Medical Center were some of the hospital locations included in the FDA power morcellator investigation.
The inquiries into the power morcellator deaths came as a response to a letter written by Congressman Mike Fitzpatrick to FDA Director George Karavestos in December of last year.
The letter alleged that several hospitals did not report patient complications and deaths that resulted from the use of power morcellator devices.
The FDA responded to Congressman Fitzpatrick on March 29 by letter, stating “In recent months, we have conducted inspections of hospitals highlighted in your latter, including Brigham & Women’s Hospital, Rochester General Hospital, and the University of Rochester Medical Center,” the FDA stated.
Section 803 of Title 21 of the Code of Federal Regulations mandates that manufacturers and hospitals are required to report adverse events such as serious injuries or deaths that occur following the use of a medical device. The reports are to be made directly to the FDA within 10 to 30 days of the event.
The FDA’s response did not outline the details of any criminal investigations being conducted at any of the hospital but only confirmed the hospitals were being investigated.
“In order to protect the integrity of the investigative process, it is FDA’s policy not to confirm or deny the existence of a criminal investigation, Dayle Cristinzio, Acting Associate Commissioner at U.S. Food and Drug Administration, Office of Legislation told Congressman Fitzpatrick in the letter. “FDA appreciates your interest in this issue and we will continue to keep you and your staff apprised of any updates.”
Power Morcellator Controversy
A power morcellator is a medical device used in minimally invasive surgeries in gynecology, specifically for hysterectomy and uterine fibroid removal.
A small incision is made into the patient, and the morcellator is inserted into the surgical opening. The rotating blades on the device cut the tissue into small pieces which can then be removed through the tiny incision.
The controversy over the devices centers on women that may have undiagnosed cancer cells that can potentially be disturbed by the power morcellator.
Once the morcellator disturbs the cancerous cells, they can be quickly disseminated throughout the abdominal cavity, leading to advanced stage uterine cancer. What started as easily treatable fibroids can quickly become a death sentence for women with this condition.
The FDA estimates that about 1 in 350 women have undiagnosed cancer that can potentially be spread by the power morcellator that can cause upstaged uterine cancer. In 2014, the FDA issued a warning about the increased risk of uterine cancer relating to power morcellator use.
Johnson & Johnson, the largest manufacturer of the power morcellator, removed its devices from the market shortly after the FDA warning.
Currently, many hospitals have abandoned the use of power morcellator devices altogether and many insurances no longer cover surgeries that use a power morcellator.
Following the FDA’s warning, updated warnings were called to be included on power morcellator labels, but currently the devices are still available on the market.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Morcellation
Full Text of Stories Below
Add recipients
Suggested