April 9, 2016 |
The U.S. Food and Drug Administration on Thursday announced the approval of the first tissue-containment bag for use with a gynecological surgical device that can spread undetected cancer. At the same time, the agency continued to warn that the tissue-slicing surgical device, called a power morcellator, should not be used in most cases. And the FDA further warned that the new bag "has not been proved to reduce the risk of spreading cancer. " The FDA estimates that about 1 in 350 women who undergo hysterectomy or uterine fibroid removal will have an unsuspected sarcoma, an aggressive uterine cancer.
November 6, 2015 |
A renowned Boston medical center was ordered by a judge Tuesday to stop imposing extraordinary security measures on a Bucks County cancer patient and her husband, who have been sharply critical of Brigham and Women's Hospital. The Massachusetts judge agreed with the couple, Amy Reed and Hooman Noorchashm, that the security was intended to intimidate them, and violated their right to free speech as well as the hospital's own policies. Hospital officials declined to comment. Reed, 42, an anesthesiologist at the University of Pennsylvania, and Noorchashm, 43, a cardiac surgeon at Thomas Jefferson University Hospital, have led a highly effective national campaign to ban a gynecological surgical device that Brigham doctors used to perform her hysterectomy two years ago. The tissue-slicing device, an electric morcellator, spread her hidden uterine cancer - a danger that they have since publicized.
September 7, 2015 |
The U.S. Government Accountability Office has agreed to investigate why an electric device used in gynecological surgery was marketed for two decades before safety warnings were issued by the Food and Drug Administration. The GAO, which investigates how the government spends tax dollars, sent a confirmatory letter to U.S. Rep. Mike Fitzpatrick (R., Pa.). He and 11 other members of Congress requested the probe last month. The tissue-slicing device, called a power morcellator, enables hysterectomies to be done through small abdominal incisions, but it can also spread and worsen undetected uterine cancer.
August 9, 2015 |
Twelve members of Congress have asked the U.S. Government Accountability Office to investigate why an electric device used in gynecologic surgery was marketed for two decades before safety warnings were issued by the Food and Drug Administration. The tissue-dissecting device, called a power morcellator, enables hysterectomies to be done through small rather than large abdominal incisions, but it can also spread and worsen an undetected uterine cancer. After that horrible scenario befell anesthesiologist Amy Reed at a Boston hospital in late 2013, she and her husband, heart surgeon Hooman Noorchashm, launched a campaign to ban electric morcellators.
March 6, 2015 |
Amy Reed, the doctor who has pushed for a ban on the gynecological surgery device that worsened her uterine cancer prognosis, said Wednesday that she is fighting a recurrence. Reed, 41, had about a year in apparent remission after her 2013 diagnosis and treatment for leiomyosarcoma, a rare and ferociously aggressive uterine cancer. Two weeks ago, she had surgery at the Hospital of the University of Pennsylvania to remove a small tumor that a scan revealed in the bony part of her spinal column.
February 21, 2015 |
The dangers of a power tool used in gynecological surgery have been debated for more than a year, with experts offering varying estimates of the chance that an undetected uterine cancer would be spread - and likely worsened - by the tissue-slicing device. Now, two new studies have waded into the controversy. Using a nationwide insurance claims database, Columbia University researchers looked at women treated for uterine growths called fibroids. Uterine cancer was discovered in one out of every 1,073 who underwent power morcellation, and one out of 528 without morcellation.
May 22, 2014 |
Two doctors' groups are defending a tissue-cutting device that makes gynecological surgery less invasive but in rare cases spreads a hidden uterine cancer. Electric morcellators, introduced in 1993, are used to dissect the uterus or uterine fibroids so tissue can be removed through small abdominal incisions. They have come under scrutiny in recent months because the motorized blade can disseminate bits of undetected cancer. Many hospitals have halted their use; the Food and Drug Administration last month issued a safety advisory "discouraging" power morcellation; and Johnson & Johnson suspended worldwide sales of its version of the machine.
April 1, 2014 |
The husband-and-wife doctors who have turned their personal tragedy into a public health crusade are getting traction. Cardiothoracic surgeon Hooman Noorchashm and his wife, anesthesiologist Amy Reed, 40 - both trained in Philadelphia and affiliated with Harvard Medical School - want electric tissue-cutting morcellators banned from gynecologic surgery. Power morcellation, introduced in 1993, enables tissue removal through tiny abdominal incisions, but in rare cases it can also spread a hidden uterine cancer called leiomyosarcoma.
March 19, 2014 |
The husband of a Berks County woman who died of a rare uterine cancer following a minimally invasive hysterectomy is suing the maker of the device used in her surgery at Reading Hospital. The lawsuit, filed Friday in federal court in Philadelphia, adds to controversy over electric tissue-cutting "morcellators. " The devices let doctors remove tissue through tiny abdominal incisions, shortening patients' hospitalization and recovery. In rare cases, the process can disseminate an aggressive uterine cancer, leiomyosarcoma, that routine diagnostic tests usually miss.