publication date: Nov. 19, 2015

FDA: Federal Law Requires Reporting of Morcellation Adverse Events, But None Were Brought to Agency’s Attention For 8 Years

FDA officials said the agency didn’t receive any reports of adverse outcomes resulting from power morcellation prior to December 2013.

“Of note, prior to December, the FDA had received no MDRs specifically on cancer and upstaging/dissemination,” the agency said in response to questions from The Cancer Letter. “Since then, the agency has become aware of about two dozen that have discussed ‘cancer’ and ‘upstaging or dissemination’ as of November 2014. All of these reports pertained to procedures that took place prior to December 2013.”

Robert Lamparter, a retired pathologist, alerted Ethicon, a Johnson & Johnson subsidiary, about potential problems with morcellators in 2006. The Pittsburgh Business Times reported on the whistleblower case in May 2014.

A full account of Lamparter’s 2006 complaint is published here.

According to an FDA advisory in April 2014, one in 350 women with undergoing hysterectomy for the treatment of is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma.

Two women—Erica Kaitz and Amy Reed—underwent power morcellation performed at Brigham & Women’s Hospital in 2012 and 2013, respectively. Kaitz died on Dec. 7, 2013 from metastatic leiomyosarcoma, and Reed recently underwent surgery for a third recurrence (The Cancer Letter, Nov. 26, 2014, Nov. 3, 2015).

Responding to similar questions from Rep. Mike Fitzpatrick (R-Pa.), FDA said it disagrees with the 2011 recommendations from the Institute of Medicine, which called for an overhaul of the agency’s 510(k) process for clearing devices (The Cancer Letter, July 4, 2014).

“The Institute of Medicine made eight recommendations to FDA, one of which was that FDA should design a new system for the review of Class II devices,” FDA wrote to Fitzpatrick. “While FDA does not agree with IOM’s recommendation to create a new system, we do believe that we can make improvements to the current system and we have worked to do so over the past four years.”

FDA responded to questions from Matthew Ong, a reporter with The Cancer Letter.

 

Matthew Ong: Knowing what we know now, should the power morcellator have gone through more rigorous testing before it was cleared for the market?

FDA: Having more rigorous testing of morcellators before clearance likely would not have addressed the issue of spreading unsuspected cancer through morcellation, because uterine sarcomas are a rare type of cancer; the rate of unsuspected uterine sarcoma in women undergoing hysterectomy or myomectomy for the treatment of uterine fibroids is about 1 in 350.

Even a large clinical trial involving hundreds of patients would have been unlikely to detect these events. After the risks of power morcellators spreading unsuspected cancer became known, the FDA took several steps to reduce the risk of spreading unsuspected cancer by laparoscopic power morcellation during fibroid surgery, including asking manufacturers to add a boxed warning to product labels specifying:

1) Laparoscopic power morcellators are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are: peri- or post-menopausal, or are candidates for en bloc tissue removal, e.g. through the vagina or mini-laparotomy incision. (These groups of women represent the majority of women with fibroids who undergo hysterectomy and myomectomy.)

2) Laparoscopic power morcellators are contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy.

The contraindications cover a majority of women who would undergo morcellation during myomectomy or hysterectomy. This should help to reduce the use of the device in patients at greatest risk.

The FDA has also asked manufacturers to include the following boxed warning in their product labeling: 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.

MO: Are there any lessons to be learned at FDA from the power morcellation case?

FDA: Any device cleared or approved for marketing carries a certain element of risk that must be weighed against potential benefits offered to patients. FDA believes there is an opportunity for manufacturers to develop products that may further reduce this risk of spreading existing cancer.

Better diagnostics aimed at detecting uterine cancer as well as containment systems designed specifically for gynecological surgery could be helpful. Experts from our July 2014 panel meeting agreed that innovation in these areas may further address this risk.

The FDA continues to actively work to strengthen its medical device post market surveillance system.

MO: Does FDA have any plans to tighten the medical device clearance process i.e. the 510(k) or to seek additional authority from Congress to do so?

FDA: The 510(k) program works well to determine whether new devices are substantially equivalent to a previously cleared device, meaning that the new device is as safe and effective as its predicate.

We’ve had tens of thousands of good products come on the market through that pathway, and it encourages manufacturers of lower risk devices to make important upgrades to enhance the performance of their device without having to go through the expense of a premarket approval.

FDA does acknowledge that the clearance process can be improved, and we remain open to opportunities to enhance the programs we have whether through a program reform, or if there are appropriate changes that can be made to the law, to new legislation.

MO: How would the 21st Century Cures Act—if passed in its current form—change regulation of medical devices at FDA?

FDA: FDA cannot predict how this legislation will affect device regulation in the future since it is still in transitory stage and has not yet been passed by both houses of Congress or signed into law.

MO: Is it true that manufacturers and user facilities—Johnson & Johnson/Ethicon and Brigham & Women’s Hospital—did not report adverse events resulting from power morcellation as per the Section 803 Title 21 mandate? Does FDA see a need to ensure that user facilities report in a more robust fashion? 

FDA: Manufacturers, such as J&J/Ethicon, are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury.

Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

A “device user facility” is a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility, which is not a physician’s office.

User facilities are required to report a suspected medical device-related death to the FDA and the manufacturer within 10 workdays of becoming aware of the event. They must report serious device-related injuries to the manufacturer and to the FDA if the manufacturer is unknown.  

With regard to the spread of unsuspected cancer when using laparoscopic power morcellation for hysterectomy or myomectomy in women with symptomatic uterine fibroids, the FDA has clarified that it considers such an event to be reportable as a serious injury.

The FDA has generally focused its enforcement resources on manufacturers—who are required under law to investigate any MDR-reportable complaint they receive—and not on hospitals.

The FDA has found that encouraging more reporting—and more complete reporting—by hospitals/user facilities and physicians, is a good use of the limited resources in this area.

Of note, prior to December, the FDA had received no MDRs specifically on cancer and upstaging/dissemination. Since then, the agency has become aware of about two dozen that have discussed ‘cancer’ and ‘upstaging or dissemination’ as of November 2014. All of these reports pertained to procedures that took place prior to December 2013.

The timing of these reports may be due to the heightened sensitivity and media attention given to the subject in late 2013. The FDA is still analyzing the adverse event data it has received on morcellation.

MO: Is it true that some PMA-approved devices (and/or 510k-cleared devices) are exempt/excluded from civil/product liability litigation because FDA has approved them?

FDA: The FDA does not “exempt” devices from lawsuits.  Rather, certain state requirements that apply to medical devices are preempted under section 521 of the Federal Food, Drug, and Cosmetic Act.

Interpreting this provision, the Supreme Court has said that state common law claims relating to approved class III devices generally are preempted.  In other words, people injured from a class III, PMA-approved device typically cannot recover damages from device manufacturers for their injuries under state common law theories.

In contrast, the Court has said that such claims are generally not preempted under section 521 when they relate to class I devices.

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