Preview Newsletter
Morcellation Media Monitoring 12/14/2015
-
Physicians find FDA ruling flawed, misleading on uterine surgery
Dec 10, 2015 | Healthcare Dive
By Nina Flanagan
A group of nearly 50 doctors signed an open letter to the FDA stating the agency's ruling last year relied on a flawed analysis in restricting removal of noncancerous uterine growths to open surgery. -
Doctors Petition FDA To Loosen Power Morcellator Restrictions
Dec 12, 2015 | Righting Injustice
By Jennifer-Walker Journey
Nearly four dozen physicians signed an open letter to the Food and Drug Administration (FDA) urging the agency to rethink its decision to place restrictions on power morcellator devices used to perform hysterectomies and myomectomies (uterine fibroid removals), and empower women with the freedom to make their own decisions with their surgeons as to which procedure is right for them. -
Study Analyzing Cost-Effectiveness Of Power Morcellation Raises Ire Among Cancer Victims
Dec 10, 2015 | Righting Injustice
By Jennifer Walker
Minimally invasive, laparoscopic power morcellation is a more cost-effective alternative to open surgery for hysterectomies and myomectomies (uterine fibroid removal), but the surgical tools can spread undiagnosed uterine cancer, worsening the odds of survival, according to a study published in a recent issue of The Journal of Minimally Invasive Gynecology. -
Lawsuit: Morcellator Caused Cancer to Spread in Woman
Dec 10, 2015 | Top Class Actions
By Joanna Szabo
A husband and wife from Florida recently filed a morcellator cancer lawsuit alleging that Ethicon’s Gynecare morcellator device caused devastating injuries, including the spread of undetected, malignant cancer cells.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Morcellation
Full Text of Stories Below
-
Physicians find FDA ruling flawed, misleading on uterine surgery
Dec 10, 2015 | Healthcare Dive
By Nina Flanagan
Dive Brief:
A group of nearly 50 doctors signed an open letter to the FDA stating the agency's ruling last year relied on a flawed analysis in restricting removal of noncancerous uterine growths to open surgery.
The agency ruled in November 2014 noncancerous uterine fibroids could no longer be removed by power morcellators that chop up the growths into small pieces for removal by minimally invasive surgery. It stated one in 485 women with fibroids could also have a potentially lethal hidden cancer (leiomyosarcoma) spread by the use of the morcellators.
However, Dr. William H. Parker from UCLA School of Medicine told Reuters the agency's assessment of the number of women with this cancer having fibroid surgery "was flawed, inadequate and misleading."
Dive Insight:
The physicians said studies the FDA used in their review lacked credibility. After reviewing the study data, the group said there were only eight cases of leiomyosarcoma in 12,402 fibroid surgeries, which is only 0.07%.
By eliminating minimally invasive surgery for uterine fibroids, the FDA's ruling forces women to have open surgery, which has more risks and complications.
The open letter to the FDA concludes, "Women have a right to self-determination. Modification of the FDA's current restrictive guidance regarding power-morcellation would empower each woman to consider the pertinent issues and have the freedom to undertake shared decision-making with her surgeon in order to select the procedure which is most appropriate for her."
Dr. Jason D. Wright from Columbia University College of Physicians and Surgeons told Reuters Health, "I think as more data becomes available, the FDA should ultimately readdress this topic." However, he said he doubts the FDA will change its policy in the near future.
-
Doctors Petition FDA To Loosen Power Morcellator Restrictions
Dec 12, 2015 | Righting Injustice
By Jennifer-Walker Journey
Nearly four dozen physicians signed an open letter to the Food and Drug Administration (FDA) urging the agency to rethink its decision to place restrictions on power morcellator devices used to performhysterectomies and myomectomies (uterine fibroid removals), and empower women with the freedom to make their own decisions with their surgeons as to which procedure is right for them.
“I think physicians should understand that there is certainly a safety concern with morcellation and they need to use caution to minimize the risk of inadvertently morcellating a precancerous or cancerous lesion,” said Dr. Jason Wright, with the Columbia University College of Physicians and Surgeons in New York City, to Reuters Health. “The corollary is that in some women the benefits of morcellation may outweigh the risks.
Power morcellation is a surgical tool fitted with a tube-like blade that shreds uterine fibroids or entire uteruses and removes the bits of tissue through a small incision in the abdomen. The devices have been favored for some hysterectomies and myomectomies over open surgery because morcellation offers shorter recovery and less risk of potentially life threatening complications.
But advocates, including women who have undergone power morcellation procedures, argued otherwise. If power morcellation is performed on a woman with undetected uterine cancer, the procedure can fling bits of cancerous tissue throughout the abdomen, seeding new cancer growth and worsening a woman’s odds of survival.
Because there is no reliable way of detecting some forms of uterine cancer, such as uterine sarcoma orleiomyosarcoma, without first removing uterine tissue, the FDA concluded following a safety review that the procedures should not be used on most women. An estimated 1 in 485 women with uterine fibroids also hasleiomyosarcoma, the agency said.
Many doctors who have used power morcellation frowned on the FDA’s decision and are calling for the agency to rethink its actions. “Their recommendations were not based on science, but rather on emotional and anecdotal information,” Dr. William Parker with the UCLA School of Medicine in Los Angeles, told Reuters Health.
Dr. Parker and a team of top gynecologists in the Leiomyoma Morcellation Review Group say the FDA based its decision on studies that lacked credibility and used data that was not accurate. They claim that the risk of a woman having leiomyosarcoma is 1 in 1,150.
The agency’s action to limit morcellation forces women to have open surgery through a larger incision, instead of laparoscopy as with power morcellation, and that can increase surgery-related deaths and complications.
However, for the women who have undergone power morcellation and were shortly afterwards diagnosed with advanced uterine sarcoma, the fight to ban power morcellation pales in comparison to the fight for their lives.
-
Study Analyzing Cost-Effectiveness Of Power Morcellation Raises Ire Among Cancer Victims
Dec 10, 2015 | Righting Injustice
By Jennifer Walker
Minimally invasive, laparoscopic power morcellation is a more cost-effective alternative to open surgery for hysterectomies and myomectomies (uterine fibroid removal), but the surgical tools can spread undiagnosed uterine cancer, worsening the odds of survival, according to a study published in a recent issue of The Journal of Minimally Invasive Gynecology.
The study adds more fuel to the raging firestorm surrounding power morcellation devices. The gynecological tools are fitted with a long blade that minces uterine growths or entire uteruses inside the body and removes the tissue through a small incision in the abdomen. The procedures have been favored over open surgeries because they are less invasive, leave less scar tissue, and offer shorter recovery.
Power morcellation is also about $10,000 less expensive than open surgeries. One major factor for the difference in cost between the two options is the cost of prolonged hospitalizations and the costs to patients for spending a longer time away from work for recovery. “Eliminating morcellation hysterectomy as a treatment for fibroids is not cost-effective under a wide variety of probability and cost assumptions. Performing laparotomy for all patients who might otherwise be candidates for morcellation hysterectomy is a costly policy from a societal perspective,” the authors concluded.
But many hospitals are discontinuing performing hysterectomies and myomectomies with power morcellators after the Food and Drug Administration (FDA) discouraged use of the tools for most women. The agency said that about one in 350 women have a type of uterine cancer, called uterine sarcoma, which is difficult to diagnose without first removing the tissue. If power morcellation is performed on a woman with undiagnosed uterine sarcoma, the device could fling bits of cancerous tissue throughout the abdomen, seeding new cancer growth and making the disease more difficult to treat.
It’s a painful price to pay for women who have the disease, including Dr. Amy Reed, who underwent power morcellation in 2013 and shortly thereafter discovered she had advanced stage uterine sarcoma. She and her physician husband, Dr. Hooman Noorchashm, have become activists in the fight to ban power morcellation.
“Basically, this is … making a financial argument to justify something … that places the lies of the minority subset of women in deadly harm’s way. That is ethically blind,” Noorchashm said of the cost study.
-
Lawsuit: Morcellator Caused Cancer to Spread in Woman
Dec 10, 2015 | Top Class Actions
By Joanna Szabo
A husband and wife from Florida recently filed a morcellator cancer lawsuit alleging that Ethicon’s Gynecare morcellator device caused devastating injuries, including the spread of undetected, malignant cancer cells.
Plaintiff Michelle D. and her husband claim that laparoscopic surgery performed with a Gynecare LPM, a power morcellator device, directly led to the spread of hidden uterine cancer throughout Michelle’s body. The morcellation cancer has cause the couple pain and suffering an ultimately worsened Michelle’s long-term prognosis.
According to the morcellator cancer lawsuit, Ethicon knew or should have known of the Gynecare power morcellator propensity to cause hidden cancer tissue to spread throughout a patient’s body.
The company should have been aware of the fact that their product could greatly worsen a woman’s chance of survival if she had hidden malignant tissue that spread.
The lawsuit further alleges that Ethicon (a subsidiary of Johnson & Johnson)was aware of evidence that power morcellators could cause significant injury decades prior to Michelle’s surgery but failed to disclose this information to patients and the medical community.
Michelle and her husband filed this power morcellator lawsuit on multiple counts, including negligence, defective design, and loss of consortium (loss of intimacy with a spouse).
Power Morcellator Risks
A medical device known as a power morcellator has been in use by surgeons across the U.S. since 1991, when it was first approved by the U.S. Food and Drug Administration (FDA). Power morcellation is a laparoscopic surgical process by which unwanted tissue is cut and shred in the body cavity, in order that it may be removed in smaller, more manageable pieces.
However, reports of power morcellation complications associated with gynecological surgeries such as hysterectomies or myomectomies have been increasing in recent years.
During a hysterectomy or myomectomy, a power morcellator cuts up uterine fibroids for removal. If the uterus or uterine fibroids contain some form of uterine cancer, the power morcellator, cutting tissue into tiny pieces, can actually spread undetected cancer cells throughout the body.
Most women develop uterine fibroids, but usually do not experience serious symptoms. For other women, these fibroids can cause prolonged menstrual bleeding, as well as pelvic pain and other unwanted symptoms, necessitating uterine surgery to remove the fibroids.
According to the FDA, approximately 1 in 350 women who undergo these kinds of power morcellator procedures will have undetected uterine cancer that can spread to other parts of the body, taking root and becoming a potentially life-threatening cancer.
The cancer risks includes leiomyosarcoma, a rare and aggressive cancer that is life-threatening if spread throughout the body.
Power Morcellator Lawsuits
A growing number of women and their families have begun filing power morcellator lawsuits, alleging cancer diagnosis after a fibroid removal surgery or other gynecological procedure that involved the use of power morcellator. These plaintiffs allege that had they been adequately warned about the potential dangers of power morcellation, they would not have agreed to the procedure or opted for an alternative type of surgery.
If you or someone you know has undergone a laparoscopic surgery where a doctor has used a power morcellator, and have since developed cancer, you may be able to file a morcellator cancer lawsuit.
The Morcellator Cancer Lawsuit is Case No. 8:15-cv-02662-MSS-AEP, in the U.S. District Court for the Tampa Division of the Middle District of Florida.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Morcellation
Full Text of Stories Below
Add recipients
Suggested