Tuesday, February 2, 2016

Lawmaker: Morcellator Companies May Not Have Reported Complications to FDA

cancer-cell-morcellatorA lawmaker, who is chairman of the Subcommittee on Oversight and Investigations, recently questioned whether Johnson & Johnson and Brigham & Women’s Hospital violated federal laws by failing to report adverse morcellation complications.

Rep. Tim Murphy of Pennsylvania questioned a Food and Drug Administration (FDA) official about whether or not hospitals and power morcellator manufacturers were effectively notifying the FDA about morcellator complications.

According to Murphy, Johnson & Johnson was aware of complications that went hand-in-hand with power morcellator devices since at least 2006.

Murphy cited a report from Dr. Robert Lamparter, a Pennsylvania pathologist. Lamparter found that approximately one out of every 300 morcellated tissue samples from his hospital had evidence of hidden cancer. This kind of hidden cancer, during a morcellator hysterectomy, could lead to power morcellator cancer.

At a hearing for the Subcommittee on Health, Murphy was intent on discovering how much the FDA knew about incidents like these. According to the FDA representative, he was not personally aware of whether or not the FDA knew if certain power morcellator hysterectomy fatalities were reported to the FDA by either Johnson & Johnson or Brigham & Women’s Hospital.

While Brigham declined to comment on the issue, Johnson & Johnson’s subsidiary Ethicon said that, prior to December 2013, the company was not even aware of any reportable power morcellator complications.

An Ethicon spokesperson acknowledged Dr. Lamparter’s report, but said that his report was less of a ‘reportable event’ and more of a ‘complaint.’

While the FDA has said that prior to December 2013, it received no adverse event reports from the power morcellator device, about two dozen cases of power morcellator cancer have been reported since that time.

There has been an ongoing string of investigations regarding the power morcellator cancer controversy.

The Federal Bureau of Investigation and the Government Accountability Office, separately, are also reportedly investigating the power morcellator cancer issue.

What is Power Morcellation?

The power morcellator is a device first approved by the FDA in 1991, and is used to remove fibroids in uterus. Power morcellators make extremely small incisions, which makes surgery go more smoothly for patients, and helps morcellator hysterectomy patients recover more quickly.

Power morcellation is a process by which unwanted tissue is cut and shred in the body cavity, in order that it may be removed in smaller, more manageable pieces.

Power Morcellator Cancer

According to reports, while the power morcellator is used to remove fibroids in uterus, it can also cut up surrounding tissue fragments that may be cancerous. Once these cancerous tissue fragments are cut, these fragments are then able to spread to other parts of the body.

In response to the FDA’s warnings, Ethicon eventually pulled its power morcellator device off the market. Ethicon, a subsidiary of Johnson & Johnson, is the largest single manufacturer of power morcellators.

Power Morcellator Lawsuits

A growing number of people have begun filing power morcellator lawsuits, alleging cancer diagnosis after a morcellator hysterectomy or surgery that involved power morcellation. These plaintiffs allege that, had they been adequately warned about the potential dangers of power morcellation, they would not have agreed to the morcellation procedure.

If you or someone you know has undergone a surgery where a doctor has used a power morcellator, and have since been diagnosed with cancer, you may be able to file a morcellator cancer lawsuit.

Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The morcellation cancer attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or class action lawsuit is best for you. [In general, morcellator cancer lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.

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Get Help – It’s Free

Join a Free Morcellation Cancer Class Action Lawsuit Investigation

If you or a loved one were diagnosed with cancer in the uterus, pelvis or abdomen within two years of undergoing surgery for a myomectomy (removal of fibroids), hysterectomy (removal of the uterus), oophorectomy (removal of the ovaries), or salpingectomy (removal of fallopian tubes), you may have a legal claim. See if you qualify by filling out the short form below.

An attorney will contact you if you qualify to discuss the details of your potential case at no charge to you.

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