Morcellation Media Monitoring 10/15/2015

Client Attorney Privileged/Attorney Work Product/At Request of Counsel

Morcellation

1. Power Morcellation Hysterectomies on the Decline, Study Shows

   Oct 15, 2015 | Top Class Actions

   By Tamara Burns
   
   
   A study published recently in the American Journal of Obstetrics and Gynecology showed that a fewer number of women underwent procedures using power morcellation since the April 2014 FDA warning. The study looked at women who underwent hysterectomy for benign reasons from January 1 through December 31 of 2014. After the FDA warning on April 17 of that year, the number of surgeries using power morcellation showed a 4.1 percent decline.
2. Power Morcellation Investigation Launched Against FDA

   Oct 13, 2015 | Top Class Actions

   By Tamara Burns
   
   
   Lawmakers have urged the U.S. Government Accountability Office (GAO) to investigate the Food and Drug Administration’s regulation of power morcellators. Twelve members of Congress wrote a letter to the GAO explaining that, “Hundreds, if not thousands of women in America are dead because of a medical device known as a laparoscopic power morcellator.”
3. Morcellator Lawsuit News: FDA’s Approval Process For Medical Devices Under Investigation

   Oct 13, 2015 | Southern Med Law

   The rising number of power morcellator lawsuit claims alleging morcellators spread cancer in women undergoing gynecological surgeries and pleas to ban morcellators have prompted an investigation into the U.S. Food and Drug Administration’s (FDA) expedited approval process for medical devices. A bipartisan Congressional group requested the investigation noting “hundreds, if not thousands of women in America are dead,” due to power morcellators.

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Client Attorney Privileged/Attorney Work Product/At Request of Counsel

Morcellation

1. Power Morcellation Hysterectomies on the Decline, Study Shows

   Oct 15, 2015 | Top Class Actions

   By Tamara Burns

   A study published recently in the American Journal of Obstetrics and Gynecology showed that a fewer number of women underwent procedures using power morcellation since the April 2014 FDA warning.

   The study looked at women who underwent hysterectomy for benign reasons from January 1 through December 31 of 2014. After the FDA warning on April 17 of that year, the number of surgeries using power morcellation showed a 4.1 percent decline.

   What is Morcellation?

   Morcellation is the use of a device called a power morcellator to assist in surgery. Most commonly, these machines are used during hysterectomy procedures as well as for removing uterine fibroids (myomectomy).

   During these surgeries, a small incision is made in the abdomen, and the power morcellator is inserted to divide the tissue into smaller pieces to remove fibroids or the entire uterus through the tiny opening.

   FDA Warning on Morcellation

   In April 2014, the FDA issued a warning urging doctors to not use power morcellators on women who are undergoing surgery for a hysterectomy or myomectomy.

   One in 350 women are who are undergoing surgery to remove fibroids or to have a hysterectomy are estimated to have an unsuspected cancer of the uterus called uterine sarcoma, a type of cancer that also includes leiomyosarcoma.

   Using a power morcellator to break up the tissue may disturb the cancerous tissue and cause it to spread to the pelvis and abdomen. Once the cancer has spread, the outcome of successful treatment for cancer is lessened, and chances for long-term survival are significantly reduced.

   The FDA determined that there was no way to improve the power morcellation devices to make them safer. In November 2014, the FDA issued a statement that they would allow power morcellators to remain on the market but the manufacturers would be required to include substantially stronger warnings on the devices.

   This move by the FDA received a lot of criticism for those who believed that power morcellators should be removed from the market.

   Many hospitals no longer use power morcellators to perform hysterectomy or myomectomy procedures but there are still many hospitals that do use this device despite the warnings.

   Morcellation Lawsuit Information

   Many women allege they have been permanently injured from the use of power morcellation during their surgeries and have decided to pursue lawsuits against the manufacturers of power morcellation devices.

   The allegations in various lawsuits that have been filed state the devices are unreasonably dangerous and there were not adequate warnings provided to the women who underwent surgery.

   Women assert that stronger warnings would have allowed them as patients to more fully discuss with their doctors the risks and benefits associated with the minimally invasive procedure and the dangers of use of the device.

   If you or a loved one has suffered a cancer diagnosis after having a hysterectomy, uterine fibroid surgery or other procedure using a power morcellator, you may be entitled to legal compensation. Attorneys are available to confidentially discuss your unique situation to inform you of your options.

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2. Power Morcellation Investigation Launched Against FDA

   Oct 13, 2015 | Top Class Actions

   By Tamara Burns

   Lawmakers have urged the U.S. Government Accountability Office (GAO) to investigate the Food and Drug Administration’s regulation of power morcellators.

   Twelve members of Congress wrote a letter to the GAO explaining that, “Hundreds, if not thousands of women in America are dead because of a medical device known as a laparoscopic power morcellator.”

   They went on to state, “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 investigation should commence in about five months, according to a GAO spokesperson, and the FDA has agreed to cooperate.

   What Is A Power Morcellator?

   A power morcellator is a medical device used during a minimally invasive surgery, also called laparoscopic surgery. Most commonly used in gynecological surgeries, hysterectomies and uterine fibroid removal are the most common instances where the device is used.

   Through a small incision in the body, the power morcellator is inserted. It works by breaking up and dissolving fibroids into small pieces that can then be removed via the small surgical incision.

   Problems arise when a woman has previously undetected cancer cells that the power morcellator touches. The power morcellator disturbs the cancer cells and through the power of the machine, disseminates the cancer cells throughout the body.   What started out as a small number of localized cells could quickly become cancer that has spread to multiple areas in the body, causing a much poorer prognosis for treatment and survival.

   Power Morcellator Safety Warnings

   The FDA, power morcellator manufacturers, and even insurance companies have faced increased scrutiny for these medical products after major safety concerns have been raised.

   In 2014, the FDA warned against using power morcellator devices in laparoscopic surgeries for uterine fibroid removal. Reports showed that there is a 1 in 350 risk for uterine sarcoma in women undergoing gynecological procedures with morcellation devices.

   In November of 2014, the FDA issued a warning prompting a “black box label” on power morcellators. The federal agency’s recommendation was against using power morcellators for the “majority” of women needing to have fibroid removal or hysterectomy.

   Insurance companies Aetna and UnitedHealth no longer cover procedures that use a power morcellation since the FDA warning was issued. This decision was seen as a way to avoid the risk of patients developing uterine cancer.

   In the recent request for GAO investigation of the FDA, Congress stated, “In light of these concerns we respectfully request you investigate the root cause failure that ultimately led to the FDA’s black box warning on the use of laparoscopic power morcellators in Nov. 2014—over two decades after it was first approved.”

   Many hope that this investigation will provide answers so women and their families do not have after enduring a potentially fatal outcome as the result of a relatively simple procedure.

   Filing a Morcellation Cancer Lawsuit

   Due to the high volume of power morcellator lawsuits that were filed, cases were consolidated into a multidistrict litigation.

   If you or a loved one developed cancer after a surgical procedure involving the power morcellator, you may be entitled to compensation. Lawyers can advise you on filing an individual morcellation lawsuit or joining a multidistrict litigation. All consultations are confidential and are provided at no cost to you.

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3. Morcellator Lawsuit News: FDA’s Approval Process For Medical Devices Under Investigation

   Oct 13, 2015 | Southern Med Law

   The rising number of power morcellator lawsuit claims alleging morcellators spread cancer in women undergoing gynecological surgeries and pleas to ban morcellators have prompted an investigation into the U.S. Food and Drug Administration’s (FDA) expedited approval process for medical devices. A bipartisan Congressional group requested the investigation noting “hundreds, if not thousands of women in America are dead,” due to power morcellators.

   The FDA’s 501(k) approval process allows medical device manufacturers to “fast track” their products and not conduct clinical trials if they can show that their device is substantially equivalent to one that is already on the market. Manufacturers must also demonstrate that their medical devices are safe and effective. The FDA has approved 10 power morcellators for sale over the last 24 years, according to a Wall Street Journal report.
   [wsj.com/articles/members-of-congress-call-on-gao-to-investigate-surgical-tool-1438978884, August 7, 2015]

   As strong advocates for women in morcellator cancer lawsuit, Southern Med Law filed the first morcellator lawsuit claim and has since settled the complaint for an undisclosed amount. “We feel very strongly about putting an end to power morcellator manufacturers Ethicon Inc., Blue Endo, and Lina Medical from continuing to market a product that we believe is very harmful to women.”

   A group of 12 Congress members asked the U.S. Government Accountability Office (GAO) to scrutinize the FDA’s approval system which has come under fire for being too lax, according to a Wall Street Journal report. In a letter to the GAO, the legislators noted that studies pointed to a serious problem with morcellators decades before the FDA warned about the power morcellators’ potential cancer risk. The letter further said the FDA, the medical device industry and many gynecologists determined the cancer risk was low, “only one-in-10,000. How did they get it wrong for so long?”
   [fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/, August 11, 2014]
   [wsj.com/articles/members-of-congress-call-on-gao-to-investigate-surgical-tool-1438978884, August 7, 2015]

   “Southern Med Law commends members of Congress for seeking an investigation into power morcellators,” says Dr. François Blaudeau, a founder of Southern Med Law which is representing many families in morcellator cancer lawsuit claims.

   Laparoscopic power morcellators are surgical tools used during minimally invasive surgeries such as a hysterectomy or a myomectomy. The morcellator grinds uterine fibroids into shreds for removal through small incisions in the abdomen. The morcellated fragments may contain undiagnosed cancer, including leiomyosarcoma. The cancer cells can travel to various parts of the body if fragments are left in the abdomen and pelvic area or attach to surrounding organs.

   In April 2014, the FDA advised doctors not to use the tool during uterine surgery because of the potential cancer risk. The federal agency issued a stronger warning in November 2014, that all but banned the use of laparoscopic power morcellators in the majority of women undergoing a hysterectomy or myomectomy.
   [wsj.com/articles/johnson-johnson-to-call-for-voluntary-return-of-morcellators-1406754350, July 30, 2014]
   [fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm, November 24, 2014]

   Southern Med Law has been fighting for the rights of alleged morcellator cancer victims even before the FDA acted to warn the public about this potential danger. Dr. Blaudeau served as Lead Counsel in what was the first power morcellator cancer lawsuit filed in a U.S. court.

   In September, the Firm filed two morcellator cancer lawsuit claims against Ethicon Inc., a subsidiary of Johnson & Johnson which makes power morcellators. The plaintiff in one lawsuit was diagnosed with leiomyosarcoma cancer after undergoing a hysterectomy in December 2012 in which Ethicon’s Gynecare Morcellex device was used. (U.S. District Court, Eastern District of Washington, Case 2:15-cv-00252)
   The second power morcellator lawsuit was filed on behalf of a widower whose wife died of leiomyosarcoma in March 2014. His spouse had undergone a robotic laparoscopically-assisted hysterectomy and cystoscopy in June 2011, at which time the Gynecare Morcellex device was used. (Case 6:15-cv-06100, U.S. District Court, Western District of Arkansas)

   Throughout his career, Dr. Blaudeau has worked hard to develop a strong reputation in healthcare litigation. His first-hand knowledge of medicine has made the Southern Med Law team an aggressive and effective advocate for those who were harmed due to negligent medical device manufacturers. If you or a woman you love was harmed by a power morcellator, please contact Southern Med Law today to learn more about your legal rights. Call today for a free, no obligation power morcellator cancer lawsuit review by filling out our online form, or by calling the office directly at 205-547-5525.

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