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The Cancer Letter Inc.
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Washington
DC 20016
Tel: 202-362-1809
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publication date: Jul 3, 2014
ISSUE 27 - JULY 4, 2014 PDF



Harvard Physician, Whose Cancer Was Spread Through Morcellation, Seeks to Revamp FDA Regulation of Medical Devices

On Oct. 17, 2013, a surgical instrument called a power morcellator tore into the uterus of Amy Reed, an anesthesiologist at Beth Israel Deaconess Medical Center, pulverizing what were believed to be benign fibroids.

Reed’s “minimally invasive” hysterectomy, a routine procedure, was performed at the Brigham and Women’s Hospital, a teaching hospital of Harvard Medical School.

Alas, Reed’s uterus contained an occult sarcoma, which the morcellator proceeded to spread through her abdominal pelvic cavity. Over ensuing months, as Reed battled to stay alive, her husband, Hooman Noorchashm, a cardiothoracic surgeon and, at the time, a lecturer at Harvard, waged a national campaign to put an end to the practice of power morcellation.

Conversation with The Cancer Letter
Challoner: We Recommended FDA Replace 510(k) Clearance

The Cancer Letter asked David Challoner, emeritus vice president for health affairs at the University of Florida, to discuss FDA’s 510(k) medical device clearance process.

The process has come under scrutiny after laparoscopic power morcellation procedures were found to spread previously undetected sarcomas inside benign fibroids.

Challoner chaired an Institute of Medicine committee tasked by FDA and Congress in 2009 to review the 510(k) approval process. 

photo Bertagnolli: Why Brigham Stopped Making Morcellation Available Outside of a Registry Trial

“We know that this improves patient care,” Bertagnolli said in an interview with Matthew Bin Han Ong, a reporter with The Cancer Letter.

“In a case such as this one, close communication between the oncology and general gynecology communities is a key requirement for reducing morbidity and deaths due to uterine sarcomas.”

photo BSA Approves Trial of Carbon Ion Therapy, Extends EDRN and Provocative Questions

Question: What’s more expensive than proton beam radiation therapy?

Answer: Carbon ion radiation therapy.

With CIRT centers costing about $300 million to construct—about twice as much as proton beam centers—the potential adoption of this technology threatens to further inflate health spending worldwide.

photo In Brief
  • Li Ma and Jeffrey Tyner receive Wachter Award from AAAS

  • John Cleveland named associate director of basic science at Moffitt Cancer Center

  • The Community Oncology Alliance appoints new officers

  • Roswell Park Cancer Institute receives "outstanding" distinction from NCI

  • The American Society for Radiation Oncology names 30 new fellows


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