FDA Gives Power Morcellators Its Strongest Warning

A series of investigative articles in the Wall Street Journal examines the controversial marketing, training and use of power morcellators used in laproscopic hysterectomies and myomectomies for their role in spreading undetected cancers, and the FDA's recently updated safety warning on the devices. According the WSJ:

"The Food and Drug Administration used its authority to call for an immediate “black box” warning for laparoscopic power morcellators, the strongest caution the agency issues. Typically, such warnings on product labels undergo a lengthy comment period before being completed, lawyers for device makers said."

5 Things to Know About FDA Warning on #Morcellators, Uterine Fibroids http://t.co/biTVXT7VxG via @WSJ
— Lubin and Meyer, PC (@LubinandMeyer) December 8, 2014

The updated FDA Safety Communication on Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy states:

"Many women choose to undergo laparoscopic hysterectomy or myomectomy because these procedures are associated with benefits such as a shorter post-operative recovery time and a reduced risk of infection compared to abdominal hysterectomy and myomectomy. Many of these laparoscopic procedures are performed using a power morcellator. 

Based on an FDA analysis of currently available data, we estimate that approximately 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma. At this time, there is no reliable method for predicting or testing whether a woman with fibroids may have a uterine sarcoma. 

If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s long-term survival. While the specific estimate of this risk may not be known with certainty, the FDA believes that the risk is higher than previously understood. 

Because of this risk and the availability of alternative surgical options for most women, the FDA is warning against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids." 

Follow this link to the Wall Street Journal article, Surgical Tool Gets Strongest Warning, with links to more information and reporting on the topic.

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Lubin & Meyer PC - New England's Leader in Medical Malpractice and Personal Injury Law. Attorneys licensed and practicing in MA, NH and RI.

Boston Children's Hospital Study: Better Communication During Patient Hand-offs Reduced Errors by 30%

According to a study led by researchers at Boston's Children's Hospital, improvements in verbal and written communication between health care providers during patient hand-offs can reduce injuries due to medical errors by 30 percent. Published in the New England Journal of Medicine (NEJM), study results show that I-PASS  — a bundled system of communication and training tools for hand-off of patient care between providers — can greatly increase patient safety without significantly burdening existing clinical workflows.

A press release issued in conjunction with the study's publication states that medical errors in hospitals such as diagnostic delays, preventable surgical complications and medication overdoses are leading causes of death and injury in the U.S. An estimated 80 percent of the most serious medical errors can be linked to communication between clinicians, particularly during patient hand-offs.

I-PASS was designed with the goal of improving patient safety and reducing or eliminating the most common source of medical errors through improved provider-to-provider communication. I-PASS consists of:

• Standardized communication and hand-off training
• A verbal hand-off process organized around the verbal mnemonic "I-PASS" (Illness severity, Patient summary, Action list, Situational awareness and contingency planning, and Synthesis by receiver)
• Computerized hand-off tools to share patient information between providers using an I-PASS structure
• Engagement of supervising attending physicians to observe and oversee hand-off communications
• A campaign promoting the adoption of I-PASS as part of institutional process and culture

For more information on this patient safety initiative, please see: www.ipasshandoffstudy.com, and the full press release.

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Lubin & Meyer PC - New England's Leader in Medical Malpractice and Personal Injury Law. Attorneys practicing in MA, NH and RI.