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Morcellation Media Monitoring 05/14/2015
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Daughters allege El Segundo company’s medical device killed their mother
May 13, 2015 | MyNewsLA.com
By John Schreiber
The daughters of a woman who attribute their mother’s death in part to a surgical instrument used to treat her uterine fibroids are suing the El Segundo-based makers of the device. -
Movement to Ban Power Morcellation Gains Traction
May 13, 2015 | Injury Lawyer News
By Jacky Gale
The use of power morcellators has come under increasing public scrutiny recently, following recommendations against their use from the FDA and a public awareness campaign launched by Drs. Amy Reed and her husband, Hooman Noorchashm. Some patients have already filed lawsuits against the manufacturers, claiming the devices led to the spread of life-threatening uterine cancer. -
FDA issues warning letter to Smith & Nephew regarding questionable operations at plant in Andover, MA
May 11, 2015 | OrthoSpineNews
By Varun Saxena
The FDA slapped Smith & Nephew ($SNN) with a warning letter for quality-control violations at its Andover, MA, facility related to problems with some of the company’s mechanical morcellators for removal of intrauterine tissue. The company has placed a hold on shipments of its Truclear Ultra Reciprocating Morcellator 4.0 while it further investigates customer complaints.
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Daughters allege El Segundo company’s medical device killed their mother
May 13, 2015 | MyNewsLA.com
By John Schreiber
The daughters of a woman who attribute their mother’s death in part to a surgical instrument used to treat her uterine fibroids are suing the El Segundo-based makers of the device.
Sylvia O’Neil and Veronica Hernandez, the daughters of the late Rosine Hernandez, filed the wrongful death suit Tuesday in Los Angeles Superior Court against Karl Storz Endoscopy-America, Karl Storz Endovision Inc. and Karl Storz GMBH & Co.
The plaintiffs are seeking unspecified damages.
A representative for the companies could not be immediately reached.
The suit states that Rosine Hernandez underwent gynecologic surgery in January 2014 for what were thought to be benign fibroid tumors. Her doctors used a Storz morcellator, which is used for the division and removal of large masses of tissues during laparoscopic surgery, according to the plaintiffs.
However, the woman actually had a deadly uterine cancer that was not diagnosed until after her surgery. . The Storz device seeded and spread the cancer throughout her abdomen, worsening her long-term prognosis, the suit states.
The cancer continued to spread even though she underwent chemotherapy and she died on June 9 last year, according to the lawsuit.
Had the Storz instrument not spread the cancer cells during surgery, her condition would have been properly diagnosed more quickly, according to the lawsuit.
The suit alleges the Storz companies knew of the risks associated with the morcellator and failed to let doctors such as those who performed surgery on Rosine Hernandez know about them.
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Movement to Ban Power Morcellation Gains Traction
May 13, 2015 | Injury Lawyer News
By Jacky Gale
The use of power morcellators has come under increasing public scrutiny recently, following recommendations against their use from the FDA and a public awareness campaign launched by Drs. Amy Reed and her husband, Hooman Noorchashm. Some patients have already filed lawsuits against the manufacturers, claiming the devices led to the spread of life-threatening uterine cancer.
Drs. Reed and Noorchashm recently gained the support of some powerful allies in their fight against power morcellation. America’s Health Insurance Plans (AHIP), a trade association, and two congressmen from the doctors’ home state of Pennsylvania have joined forces with the duo to call for an end to power morcellation.
Congressmen join the cause
Sen. Robert Casey Jr (D-PA) and Rep. Michael Fitzpatrick (R-PA) have tried to start a dialogue with the FDA, asking why the agency has yet to ban the use of power morcellators altogether despite urging healthcare providers to discontinue usage. The FDA also updated the warning label for power morcellators. In his letter to then FDA Commissioner Margaret Hamburg, MD, Rep. Fitzpatrick noted that, “the avoidable nature of this potentially deadly hazard and unwillingness of industry advocates and many gynecologists to abandon this practice. (Power morcellators) may have caused the unnecessary or premature deaths of many hundreds (if not thousands) of American women for over two decades.”
Sen. Casey added some very pertinent questions to his letter to the FDA, asking the commissioner when and how the safety concerns first came to the attention of the FDA; what information the FDA has collected about adverse events related to power morcellators; and whether these adverse events have been definitively associated with a particular brand of power morcellator.
A spokesperson for the FDA, in response to a request for the FDA’s answers, noted that the agency was only responding directly to the congressmen. The congressmen sent their letters to the FDA on February 19, 2015. As of yet, power morcellators have still not been banned from use, which means that more unsuspecting patients may be at risk.
These women may only discover the uterine cancer risk of power morcellation after it’s too late. The numbers of power morcellator lawsuits could rise in the near future.
Life-threatening problems caused by power morcellators
The dangers associated with power morcellators are not necessarily because of the devices themselves, but rather, with an unintended consequence of gynecologic surgery. Laparoscopic power morcellators are used during hysterectomies and myomectomies. The former involves the removal of the uterus, while the latter involves the removal of uterine fibroids. In both procedures, power morcellators work by essentially tearing the large masses of tissue into tiny pieces, which can then be removed through small incisions. This allows patients to opt for minimally invasive surgery, rather than open surgery.
However, as Dr. Reed only learned after her gynecologic surgery, power morcellation can spread an existing malignancy far beyond its point of origin. In other words, as the power morcellator divides the tissue mass, it can cause cancerous cells to be propelled into other structures. This means that a woman with a previously undiagnosed stage one uterine sarcoma may come out of the surgery with stage four cancer, which has a far grimmer prognosis. In these cases, the patient or her surviving family members may choose to file a morcellator lawsuit against the manufacturer.
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May 11, 2015 | OrthoSpineNews
By Varun Saxena
The FDA slapped Smith & Nephew ($SNN) with a warning letter for quality-control violations at its Andover, MA, facility related to problems with some of the company’s mechanical morcellators for removal of intrauterine tissue. The company has placed a hold on shipments of its Truclear Ultra Reciprocating Morcellator 4.0 while it further investigates customer complaints.
Among the violations are a “failure to establish and maintain procedures for verifying or validating corrective and preventive actions” following complaints of loss of visualization when using the Truclear Ultra Reciprocating Morcellator 4.0.
The FDA said the company’s corrective action report about the problem contained insufficient information to prove that the issue had been resolved, and said the company continues to receive complaints about the problem even though the issue was first raised in September 2012. The letter also says that S&N removed a prior hold on the morcellator in 2012 before completing its review of the complaints, in violation of the company’s own policy.
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Morcellation
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