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Don't Use Ultrasonic Aspirators to Remove Uterine Fibroids FDA States

Don't Use Ultrasonic Aspirators to Remove Uterine Fibroids FDA States October 31, 2017. By Lucy Campbell.
Washington, DC: The US Food and Drug Administration (FDA) has provided the medical community with guidance on the use of ultrasonic surgical aspirators. Specifically, the agency is advising companies that make the devices to label them as contraindicated for the removal of uterine fibroids. The non-binding guidance from the agency serves to strengthen its recent warnings about the use of power morcellators to remove uterine fibroids.
Read [ Don't Use Ultrasonic Aspirators to Remove Uterine Fibroids FDA States ]

Power Morcellation Cancer Warning One Year Too Late for Doctor

Power Morcellation Cancer Warning One Year Too Late for Doctor July 10, 2017. By Jane Mundy.
:Washington, DC: Dr. Amy Reed, a physician and mother of six had surgery for uterine fibroids with a power morcelletor one year before the FDA first warned about the risk of power morcellators spreading cancer. Dr. Reed died from cancer in May—she was 44 years old.
Read [ Power Morcellation Cancer Warning One Year Too Late for Doctor ]

Olympus Settles Four Power Morcellator Lawsuits

Olympus Settles Four Power Morcellator Lawsuits June 18, 2017. By Deb Hipp.
Upper Saucon Township, PA: Olympus Corp. of the Americas has settled four lawsuits for injuries and one death allegedly related to the company's power morcellator surgical device, according to The Morning Call.
Read [ Olympus Settles Four Power Morcellator Lawsuits ]

Ovarian Cancer Survivor Blames Power Morcellator

Ovarian Cancer Survivor Blames Power Morcellator May 9, 2017. By Jane Mundy.
Victorville, CA: If Margaret knew that the FDA in 2014 had warned health providers of cancer risk in laparoscopic power morcellation surgery, she would have opted for a “traditional” hysterectomy. Two years later she finished her last round of chemotherapy to treat ovarian cancer.
Read [ Ovarian Cancer Survivor Blames Power Morcellator ]

Power Morcellation Suits Wrap Up but Doctors Still Like Procedure

Power Morcellation Suits Wrap Up but Doctors Still Like Procedure April 18, 2017. By Brenda Craig.
San Diego, CA The majority of the lawsuits brought by women who developed cancer after a power morcellator procedure to extract uterine fibroids are wrapping up usually via a settlement agreement with Johnson and Johnson.
Read [ Power Morcellation Suits Wrap Up but Doctors Still Like Procedure ]

Power Morcellators Fast-Tracked Through FDA 510(k) Clearance

Power Morcellators Fast-Tracked Through FDA 510(k) Clearance  April 16, 2017. By Gordon Gibb.
Washington, DC: As we pass the one-year anniversary of the point when medical device manufacturer Johnson & Johnson (J&J) began settling power morcellation lawsuits, women having undergone treatments for fibroids involving laparoscopic power morcellation are left wondering when, and if the other shoe might drop. This, in the wake of the death, earlier this year of a beloved advocate who championed calls for a ban on power morcellation after her own laparoscopy on February 1, 2012. Bonnie Davis died just shy of five years after her procedure, on January 6 of this year at the age of 57.
Read [ Power Morcellators Fast-Tracked Through FDA 510(k) Clearance ]

Regulatory Concern Mounting Over Power Morcellators, Adverse Events Reports

Regulatory Concern Mounting Over Power Morcellators, Adverse Events Reports February 21, 2017. By Gordon Gibb.
Washington, DC: In a blog posted to the official website of the US Food and Drug Administration (FDA) in October of last year, the regulator’s Director of the Center for Devices and Radiological Health noted that a survey conducted the year prior involving hospitals demonstrated that numerous reports of Ovarian cancer cells spread by power morcellators were not shared with the FDA’s adverse reporting system. An accompanying inspection found that in many cases hospitals had no system in place for staff to submit reports to the FDA or device makers; and that staff did not always know, or were not properly trained with regard to the reporting of injuries and deaths associated with medical devices.
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Damning Report on FDA Approval of Power Morcellators Released

Damning Report on FDA Approval of Power Morcellators Released February 9, 2017. By Lucy Campbell.
Washington, DC: According to findings from a just-released investigative report, during the past 20 years the US Food and Drug Administration (FDA) has approved 25 surgical devices such as power morcellators, that have the potential to spread undiagnosed cervical cancer in women.
Read [ Damning Report on FDA Approval of Power Morcellators Released ]

Power Morcellator Patient Advocate Dies

Power Morcellator Patient Advocate Dies January 19, 2017. By Heidi Turner.
Pittsburgh, PA Bonnie Davis, a patient who fought to ensure patients knew about the risks associated with power morcellation has died at age 57 from cancer. Davis had undergone power morcellation in 2012 and was diagnosed six days later with cancer. She worked to raise awareness of the serious risks reportedly linked to the use of power morcellators, to prevent other women from going through what she went through.
Read [ Power Morcellator Patient Advocate Dies ]

Olympus America Attempts a Power Morcellation Comeback

Olympus America Attempts a Power Morcellation Comeback December 19, 2016. By Gordon Gibb.
Orlando, FL: In spite of a position taken by the US Food and Drug Administration (FDA) that Laparoscopic Uterine Surgery for women Involving power morcellators only be used in relatively rare cases, Olympus America Inc. has released a new power morcellator equipped with a containment bag.
Read [ Olympus America Attempts a Power Morcellation Comeback ]