Legal Claims for Women Suffering Cancer Following Hysterectomy or Fibroid Surgery
Medical devices used during hysterectomy and surgery to remove uterine fibroids are suspected of spreading “cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival,” according to the United States Food and Drug Administration (FDA). These devices, known as power morcellators, are used during minimally invasive (laparoscopic) surgeries to cut uterine or fibroid tissue into smaller pieces for removal through small incisions. The risk is so significant, that as of April 17, 2014, the FDA, the agency responsible for regulating medical devices in the United States, now discourages the use of these devices for this purpose.
Goldberg & Osborne attorneys are investigating potential claims on behalf of women who may have been injured by use of power morcellators. Call Goldberg & Osborne at 1‑800‑THE‑EAGLE (1‑800‑843‑3245) or submit an inquiry via this website for a free case evaluation to determine whether Goldberg & Osborne may be able to assist you.
Surgery May Spread Undiagnosed Cancer Throughout the Abdomen Leading to Increased Cancer Recurrence and Lower Survival Rates
The FDA has explained that there is no reliable way to determine if a uterine fibroid is cancerous prior to its removal. If laparoscopic power morcellation is used in women with unsuspected cancer, there is a risk that the procedure will spread the cancerous tissue within the woman’s abdomen and pelvis, significantly worsening her likelihood of long-term survival. Additionally, use of laparoscopic power morcellation has been associated with increasing the stage of a woman’s cancer, such as from Stage I to Stage III or IV, significantly worsening her prognosis. Further, women with unsuspected uterine cancer who are subjected to power morcellation may be at significantly higher risk for cancer recurrence, and they have lower survival rates compared to women who do not receive morcellation.
The FDA has noted that the dangers of laparoscopic power morcellation are not limited to women with unsuspected uterine cancer. Laparoscopic power morcellation may also spread benign, non-cancerous, tissue throughout the abdomen and pelvis, leading to parasitic growth inside a woman’s body as well as abscess formation and peritonitis.
Manufacturers Continue to Market These Unsafe Devices in the U.S.
Laparoscopic power morcellators have been cleared by the FDA through a streamlined process under which the manufacturers must simply show that the devices are “substantially equivalent” to existing devices, without being subject to clinical testing. The FDA’s clearance process has been characterized by Public Citizen, a consumer watchdog group, as a “flawed” process “ridden with shortcomings.” Public Citizen notes that the clearance process “imposes few requirements on manufacturers to prove that proposed products are safe and effective” and that it “is especially dangerous because most of the products already on the market were themselves never tested to ensure that they are safe. Thus, a demonstration of a new product’s substantial equivalence to an existing product proves little about safety.”
The FDA has formed an Advisory Committee to consider what additional actions must be taken to protect women from these devices. According to the FDA, approximately two dozen devices have been cleared for laparoscopic power morcellation for gynecologic surgery, and these risks are not unique to any particular laparoscopic power morcellator. Only one manufacturer has voluntarily recalled the devices from the marketplace, however, and power morcellators continue to be marketed and used for this purpose, potentially risking the lives of many women. Some hospitals and physicians have voluntarily determined that until further information and guidance is available, they will no longer use laparoscopic power morcellators for fibroid removal or hysterectomy.
Experienced Goldberg & Osborne Attorneys Can Investigate Your Claim
If you or a loved one has suffered cancer following laparoscopic surgery to remove fibroids or to perform a hysterectomy, you may be entitled to compensation from the manufacturer of the device used in the surgery. Call Goldberg & Osborne toll-free at 1‑800‑THE‑EAGLE (1‑800‑843‑3245) for a free consultation, or submit a short online case inquiry here so that Goldberg & Osborne can contact you. All states have time limits in which claims must be filed, or they will be forever barred; therefore, it is crucial that you contact Goldberg & Osborne immediately.
Goldberg & Osborne has been helping people injured by the negligence of others, including multinational medical device manufacturers, since 1989. Goldberg & Osborne attorneys practice law only in Arizona but associate with attorneys throughout the United States.
U.S. Food and Drug Administration. Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication. April 17, 2014 (source).
U.S. Food and Drug Administration. FDA Executive Summary Prepared for the July 10-11, 2014 Meeting of the Obstetrics and Gynecology Devices Advisory Committee: Laparoscopic Power Morcellation During Uterine Surgery for Fibroids (source).
U.S. Food and Drug Administration. FDA Media Call on a Safety Communication on the Issue of Laparoscopic Power Morcellation for Removal of the Uterus or Uterine Fibroids. April 17, 2014 (source).
Public Citizen. Substantially Unsafe: Medical Devices Pose Great Threat to Patients; Safeguards Must Be Strengthened, Not Weakened. February 2012 (source).
Tracy Hampton, PhD. Use of Morcellation to Remove Fibroids Scrutinized at FDA Hearings. Journal of the American Medical Association. August 13, 2014 (source).
The Washington Post. Johnson & Johnson Pulls Power Morcellator; Surgical Device had Sparked Controversy. July 30, 2014 (source).