FDA Warns - Laparoscopic, or Minimally Invasive Surgery
By Paul da Costa on June 26, 2014
Women face unique health concerns as they age, particularly in terms of their reproductive well-being. Uterine fibroids, or small tumors, are one common health concern among women. While most uterine fibroids will have no symptoms, some women unfortunately experience abdominal pain or other symptoms that require surgery to correct the issue. Hysterectomies, for example, or the removal of a woman’s uterus, are a common procedure used to correct these problems. A similar procedure is a myomectomy, which is the removal of the individual uterine fibroids. Like any medical procedure, there are a variety of treatment options and risks associated with hysterectomies and myomectomies.
In order to treat the pain and symptoms associated with uterine fibroids, many women choose to undergo laparoscopic, or minimally invasive, surgery to have the fibroids or the uterus removed. Laparoscopic power morcellators are the medical devices used in these types of surgeries in order to divide tissue into smaller pieces and remove it through a small incision.
The FDA, however, has recently reported that this device carries a particular risk of spreading unsuspected cancer into the abdomen and pelvis of the woman undergoing the surgery, and therefore, it is not recommended. In other words, if a doctor is unaware that a woman has some type of uterine cancer and the woman undergoes a laparoscopic power morcellation, the procedure could cause the cancer to spread, resulting in increased harm to the woman. The FDA has reported that this danger exists in 1 in 350 cases of women undergoing a hysterectomy or myomectomy. Thus, the FDA has taken action to prevent this harm to women. The FDA has asked manufacturers of this medical device to review their labeling of these devices and plans to meet with medical professionals to discuss the risks and possible prevention.
If you underwent a hysterectomy or myomectomy and believe that the use of a morcellator during your procedure caused serious physical injury, the experienced attorneys at Snyder & Sarno LLC can help with your medical malpractice claim. Contact us today at (973) 274-5200.
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