FDA Issues Stronger Warnings Against Morcellators After Urging from Senators

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Dave Peterson Comments on New FDA Morcellator Warnings

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I am shocked that these companies are subjecting themselves to lawsuits and huge potential damages, but more importantly, they are putting lives in danger.

The U.S. Food and Drug Administration (the “FDA”) issued a new warning that the vast majority of women should not undergo power morcellation to treat uterine fibroids because the use of the device “may spread cancer and decrease the long-term survivability of patients.” These warnings come only days after U.S. Senators Elizabeth Warren and Kirsten Gillibrand urged the FDA to provide clear information to women regarding the risks associated with the procedure.

The FDA issued an Immediately in Effect (IIE) guidance (here) informing health care providers and patients that power morcellators may spread unsuspected uterine cancer. Further, the FDA is now “warning against the use of morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids.”

(FDA Safety Communication available: here)

Attorney Dave Peterson commented that “despite numerous FDA warnings and critical medical research, some manufacturers continued to sell these devices and women continue to be harmed.” Peterson continues, “I am shocked that these companies are subjecting themselves to lawsuits and huge potential damages, but more importantly, they are putting lives in danger.”

On November 18, 2014, Senators Warren and Gillibrand asked the FDA to provide clear information about the potential risks associated with morcellating undetected malignancies during laparoscopic surgeries. The Senators state that the while FDA has heard from “a range of stakeholders,” it must also “strongly consider the voices of the women and their families as you deliberate about what further actions the agency will take in regards to these devices.”

Why These Warnings are Important:

The FDA now requires that these devices carry a new boxed warning and two new contraindications.

The boxed warning informs health care providers and patients that:

  • Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.

The two contraindications advise of the following:

  • Laparoscopic power morcellators are contraindicated (should not be used) for removal of uterine tissue containing suspected fibroids in patients who are: peri- or post-menopausal, or candidates for en bloc tissue removal (removing tissue intact) through the vagina or mini-laparotomy incision. (These groups of women represent the majority of women with fibroids who undergo hysterectomy and myomectomy.)
  • Laparoscopic power morcellators are contraindicated (should not be used) in gynecologic surgery in which the tissue to be morcellated is known or suspected to be cancerous.

The FDA estimates that approximately 1 in 350 women who undergo hysterectomy or myomectomy for fibroids are found to have an unsuspected uterine sarcoma. If power morcellation is performed on these woman, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival.

Peterson commented that “these new warnings go a long way to help prevent women from receiving this dangerous procedure in the future.” However, Peterson continues, “Unfortunately, these warnings are too late for some and we are pursuing lawsuits to compensate those victims.”

Dave Peterson is currently representing several clients from around the country in morcellator litigation. If you or a loved one has developed cancer after undergoing power morcellation contact Peterson & Associates, P.C. by calling 1-800-305-7552 or visit petersonlawfirm.com for more information.

About Peterson & Associates, P.C.

Peterson & Associates, P.C. is an experienced national pharmaceutical litigation law firm that is dedicated to seeking relief for victims who suffered the consequences of dangerous drugs. Our attorneys have recovered more than $425 million on behalf of our clients and we have the knowledge and skill to successfully challenge large pharmaceutical and medical device companies. Dave Peterson has been named a Top 100 Trial Lawyer by the American Trial Lawyers Association, was awarded the prestigious Skelton Advocacy Award for Best Trial Attorney and has been named a Super Lawyer for the past 10 years running.

ATTORNEY ADVERTISING. © 2014 Peterson & Associates, P.C. The law firm responsible for this advertisement is Peterson & Associates, P.C. 801 W. 47th St., Kansas City, MO 64112, 800-305-7552. Past results afford no guarantee of future results and each case is different and is judged on its own merits. Some cases result in no recovery. Costs and expenses will be advanced and reimbursed to us only if you recover. You have no liability for costs or expenses unless a court directs. The choice of a lawyer is an important decision and should not be based solely upon advertisements. Some matters may be referred to other lawyers. Neither the Supreme Court of Missouri nor the Missouri Bar reviews or approves certifying organizations or specialist designations. Never stop taking any prescription drug without first consulting with a doctor. Not available in all states.

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David Peterson

Brian Tadtman
Peterson & Associates, P.C.
since: 05/2014
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