FDA's Release Talks of Potential Safety Issues With Power Morcellators and Other Medical Devices

January 13, 2016 (PRLEAP.COM) Health News
Power Morcellator Lawsuits Allege Laparoscopic Medical Device Can Spread Cancer In Women Undergoing A Hysterectomy Or Myomectomy.

January 13, 2016 - As power morcellator lawsuits proceed under consolidation, The U.S. Food and Drug Administration (FDA) recently released a notification on potential safety issues with certain medical devices. In the release the FDA announced it will notify the public earlier than it has in the past about potential safety issues with medical devices the agency is monitoring or analyzing. The FDA's decision comes at a time when medical devices, particularly power morcellators, have come under investigation. Additionally, power morcellator manufacturers are facing morcellator cancer lawsuits that allege their medical devices spread cancer in gynecological surgeries.

On December 31, the FDA released a draft guidance entitled, "Public Notification of Emerging Postmarket Medical Device Signals ('Emerging Signals')." In the proposal, the FDA defines an "emerging signal" as new information about a medical device used in clinical practice:

  • that the agency is monitoring or analyzing.
  • that has the potential to impact patient management decisions and/or alter the known benefit-risk profile of the device.
  • that has not yet been fully validated or confirmed.
  • for which the agency does not yet have specific recommendations.

  • "Alerting the public in a more timely manner may go a long way in increasing patient safety, particularly in cases involving medical devices such as power morcellators," says Dr. François Blaudeau, founder of Southern Med Law, which filed the first federal morcellator lawsuit in the United States. The claim has since been settled for an undisclosed amount. (No. 5:14-cv-1557, U.S. District Court, Eastern District of Pennsylvania)

    Southern Med Law is currently representing women and their families in power morcellator lawsuits. Dr. Blaudeau, the firms founder, also serves on the plaintiffs steering committee for morcellator litigation under MDL . Dr. Blaudea was also the first to file a power morcelaltor lawsuit and settle it for an undisclosed amount. The firms medical device attorneys urger anyone who believes they developed utterance cancer after a laparoscopic procedure to contact the office for more information on these medical device lawsuits.

    Under the draft guidance, the FDA proposes to alert the public about device malfunction, improper device use or design and other safety issues, even though the agency has not yet fully confirmed or analyzed the problems. "Such communication may also reduce or limit the number of patients exposed to the potential risk while the issue is being further evaluated," the FDA said.

    The Firm notes that laparoscopic power morcellators are used during a hysterectomy or a myomectomy to grind uterine fibroids into shreds for removal through small incisions in the abdomen. The morcellated fragments may contain undetected cancer, including leiomyosarcoma, and travel to various parts of the body if fragments are left in the abdomen and pelvic area or attach to surrounding organs.

    The FDA's expedited approval system for medical devices is under investigation by the U.S. Government Accountability Office (GAO). According to a Wall Street Journal report, 12 bipartisan Congress members, which accused the FDA's process for being too lax, asked the GAO to examine why the FDA did not raise the morcellator cancer risks earlier when studies had pointed to the problem decades ago. In November 2014, the FDA issued a strong warning that all but banned the use of laparoscopic power morcellators in the majority of women undergoing a hysterectomy or myomectomy.

    Morcellators manufacturers, LiNA Medical APS, Gyrus ACMI, Richard Wolf GmbH, Karl Storz GmbH, and Johnson & Johnson's Ethicon Inc., unit are facing morcellator cancer lawsuits that allege the medical devices place women undergoing fibroid removal at risk for developing uterine cancer, including a rare and aggressive form called leiomyosarcoma. The lawsuit claims accuse morcellator manufacturers of failing to warn about the dangers of their devices. Southern Med Law is currently representing women in morcellator cancer claims against Ethicon.

    About Southern Med Law and Filing A Power Mocellator Lawsuit Claim: Southern Med Law is an experienced law firm providing legal representation to the men and women across the country who have been victims of negligent personal injuries, medical malpractice, dangerous drugs, faulty medical devices and defective products. Led by Dr. François Blaudeau, an attorney and a practicing obstetrician/ gynecologist, the legal staff at Southern Med Law possesses a deep understanding of the complex medical and legal questions at issue in all manner of product liability and personal injury claims. They're not afraid to take on the nation's largest corporations in their pursuit of justice, and are committed to ensuring that all victims have access to the type of aggressive legal advocacy that assures success.

    Southern Med Law
    François M. Blaudeau, MD JD FACHE FCLM Esquire
    2224 1st Avenue North
    Birmingham, Alabama 35203
    Phone: 205-547-5525
    Cell: 205-515-6166
    Fax: 205-547-5526

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