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Power Morcellators Fast-Tracked Through FDA 510(k) Clearance

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Washington, DCAs we pass the one-year anniversary of the point when medical device manufacturer Johnson & Johnson (J&J) began settling power morcellation lawsuits, women having undergone treatments for fibroids involving laparoscopic power morcellation are left wondering when, and if the other shoe might drop. This, in the wake of the death, earlier this year of a beloved advocate who championed calls for a ban on power morcellation after her own laparoscopy on February 1, 2012. Bonnie Davis died just shy of five years after her procedure, on January 6 of this year at the age of 57.

There has been a firestorm over the devices that were once popularly deployed for uterine surgery for women without the need for invasive incisions. The use of a hand-held device inserted through a small incision, with tiny but powerful spinning blades to section fibroids and uterine tissue – together with a tube through which fragments were evacuated from the uterine cavity – had been hailed as preferential for the capacity to mitigate blood loss and to speed healing.

That is, until lawsuits began to appear over allegations that laparoscopic power morcellation was succeeding in spreading undiagnosed cancers throughout the abdominal cavity, putting women at risk for cancers that prior to their uterine surgery, appeared to remain dormant.

The year 2014 was a pivotal year. In March, 2014 the first power morcellation lawsuit appeared. A month later in April – three years ago this month – the US Food and Drug Administration (FDA) weighed in on the issue, warning against power morcellation in treatments for fibroids and in uterine surgery for women where malignancy is suspected.

In July, Johnson & Johnson pulled its power morcellator from the market (although other manufacturers have yet to do so). The FDA, while stopping short of an outright ban on the devices, warned in November against the use of laparoscopic power morcellation hysterectomy and similar treatments in a majority of women, and issued a black box warning. Hospitals were seen to step back from use of the devices, and health care plans were refusing to pay for morcellation treatments.

That was in 2014. However 15 years earlier, the Takamizawa Study released in 1999 first sounded the alarm bells with regard to the potential for spreading undiagnosed cancerous tissue throughout a woman’s abdomen from the use of laparoscopic power morcellation, and posted a risk factor of 4 in 923 women with the potential to realize a cancer diagnosis from the morcellation process. Advocates for an outright ban point to research that has been available even earlier than that – since 1990, before power morcellation achieved FDA approvals – suggesting a risk to women from the potential for spreading cancerous tissue.

The risk factor suggested by the Takamizawa Study is much higher than the FDA’s own estimate, as stated in 2014, of 1 out of 352, and much higher again than the risk factor of 1 out of 10,000 normally quoted to women prior to the procedure.

The Hagermann Study released in 2011 put the risk even higher – suggesting 1 out of 100 women had the potential for facing cancer following laparoscopic power morcellation myomectomy, or other uterine procedures.

A report issued in May, 2014 under the auspices of Advancing Minimally Invasive Gynecology Worldwide (AAGL), a professional association of laparoscopic surgeons and titled Morcellation During Uterine Tissue Extraction highlighted the concern.

That concern is not lost on Dr. Amy Reed, who herself underwent laparoscopic power morcellation hysterectomy in October 2013, and has been battling leiomyosarcoma ever since. Her latest setback was this past October when, according to the Philadelphia Inquirer (10/26/16), a tumor blocked her bowel and a major vein in her leg, necessitating a high-risk surgical procedure. Reed and her husband, Dr. Hooman Noorchashm, have been leading the charge towards an outright ban of a device that was brought to market originally through the FDA’s now-controversial 510(k) Clearance program.

The latter is a long-established loophole employed by the FDA ostensibly to get promising products to market faster by allowing manufacturers to circumvent the expensive and years-long process of a clinical trial. Provided that the device under consideration is “substantially equivalent” to a device already on the market and performing adequately, manufacturers can take a pass on the rigorous testing that would normally be required of a new device.

What device the power morcellator is ‘substantially equivalent’ to, is not clear. However in the absence of an available pool of clinical trial participants who would have been carefully monitored for adverse events, the power morcellator was effectively tested on the general population, with women in need of myomectomy, hysterectomy or treatment for fibroids, serving as Guinea pigs.

Consumer advocacy group Public Citizen has long criticized the 510(k) Clearance program, characterizing it as a “flawed” process riddled with shortcomings. The Clearance program “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.”

From the FDA website, here’s the agency’s own overview on the Clearance program…

“Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification – also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, ‘new’ devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified.

“Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. Such change or modification could relate to the design, material, chemical composition, energy source, manufacturing process, or intended use.”

The FDA continues to monitor the issue with the aid of an Advisory Committee appointed to focus on power morcellators, and laparoscopic uterine surgery for women. At a time when baby boomer women – one of the largest demographics in the American population – are hitting Menopause, uterine surgery for women will see a continuing increase in procedures. The FDA, meanwhile, continues its ‘wait-and-see’ approach, while eschewing a total ban on laparoscopic power morcellation.

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