Morcellator Hazards must be reported if Bill passes

morcellator uterine cancerMorcellator hazards must be reported if a new bill passes. Today, morcellator problems for women with undetected uterine cancer are rarely reported by doctors. Likewise for other dangerous medical devices such as transvaginal mesh or metal-on-metal hip or knee replacements. Sadly, medical professionals just don’t take the time, or don’t have the time, to report adverse medical device events as they occur. A new bill proposed last month may, however, change the whole game.

If the new bill becomes law, doctors would be required to report to the FDA potentially serious problems with medical devices they use.

The “Medical Device Guardian’s Act,” is being pushed by some members of Congress to help raise awareness of the risks of power morcellators and other hazardous medical devices.  Morcellator uterine cancer problems inspired the bill’s sponsors to change the law. A long warnings delay kept thousands of women from making informed decisions about whether or not to allow power morcellators to be used on them. Laparoscopic power morcellator alre often used for cyst removal or hysterectomy.

In 2014, the FDA belatedly called for a “black box warning” for power morcellators. The agency then announced that morcellators can spread a hard-to-detect uterine cancer during surgery.


FDA receives Delayed Reports

Though medical studies and literature had highlighted the risk of power morcellators since they were first used in the 1990s, the FDA didn’t receive any report of an adverse event until late 2013.  It took a medical professional, Dr. Amy Reed, to bring dangers of the morcellator to the agency, after a morcellator was used on her personally during a hysterectomy at a Boston hospital.

Dr. Amy Reed, Morcellator Cancer Victim

The Wall Street Journal reported that U.S. Reps. Mike Fitzpatrick (R., Pa.) and Louise Slaughter (D.,N.Y.) wrote in a letter to colleagues introducing the bill: “After that initial report from Amy, hundreds of other safety reports began to flow into the FDA.”

“In retrospect, it should not have fallen on patients to get the FDA’s attention,” the representatives said.  “[E]veryone in the chain of care” should be responsible for informing the FDA of medical device hazards.

The FDA now requires hospitals and device manufacturers to report deaths and serious injuries linked to medical devices to the agency’s database of adverse events. However, doctors are not legally mandated to inform the FDA of adverse events, though the agency encourages them to report and even accepts doctors’ reports by smartphone.

The medical device legislation proposed would add doctors and doctors’ offices to the list of mandated reporters. Bill sponsors also said the bill would protect doctors from having reports they file to the FDA used against them in civil cases. Doctors’ understandable aversion to litigation, has, of course, left some or most of them reluctant to file such reports; but it seems this caveat of the bill could open the door for a potentially troubling conundrum. Would any doctor who reports his or her involvement in an adverse medical device event then be categorically immune from any responsibility related to using the device?

Power Morcellator Problems

Doctors use power morcellators in tens of thousands of minimally invasive procedures yearly to remove benign growths known as fibroids; however, uterine cancers called sarcomas can also appear as benign fibroids that can’t be detected before surgery.  A morcellator used in such cases can spread malignancies – and other diseased tissues – inside the body, spread cancer and lead to worse outcomes.

In most cases, doctors and patients have learned only after the morcellator was used that a benign “fibroid” was in reality cancerous, after pathologists then tested the tissue.

The Government Accountability Office has since launched an investigation, and dozens of morcellator lawsuits have been filed.

J&J Morcellator Lawsuits Settled

Johnson & Johnson and Ethicon suspended sales of their power morcellators in April 2014, then withdrew them from the market in July 2014. The company has settled more than 100 legal claims and lawsuits tied to the morcellator’s cancer-spreading risk, according to attorney David Matthews, a plaintiff’s lawyer who handles medical device and pharmaceutical drug lawsuits.

A spokeswoman for J&J’s Ethicon division was quick to point out: “The resolution of these cases is not an admission of liability. (We) believe that Ethicon acted appropriately and responsibly at all times in relation to its morcellation devices. We will defend ourselves in remaining lawsuits.” The woman refused to give amounts on settled claims or to discuss their terms.

Morcellator Litigation Nationwide

Separate morcellation cases are pending against other morcellator makers nationwide, including more than 40 filed in a Los Angeles court against Karl Storz GmbH. That company has denied wrongdoing in court filings and did not respond to a request for a comment from the Wall Street Journal in June 2016.

Morcellator Hazards must be reported if Bill passes

Power morcellator problems have additionally revealed gaps in the U.S. system for tracking serious device risks.  In the congressional representatives’ letter that introduced the legislation, they noted the hospital that treated Dr. Reed also saw a patient “harmed by a morcellator one year earlier”, yet failed to inform the FDA.

The Wall Street Journal reported that Brigham and Women’s Hospital in Boston had confirmed two cases – Dr. Reed’s in 2013 and another woman’s in 2012 – in which a power morcellator spread cancer. Hospital officials, however, according to a Brigham spokeswoman, had determined these two cases weren’t reportable because the “device functioned as expected and was used in the way it was intended, although with unintended and tragic consequence.” The woman added that Brigham has since fully reported both cases.

FDA admits Limitations

Still, the bill wouldn’t be a cure-all, the FDA intimated in a statement in June 2016 that the bill would not solve device reporting problems. The agency would not comment on pending legislation, but did say the medical device reporting system has “important limitations.”

The agency is now planning a national evaluation system that would use data generated during patient care to identify safety issues more quickly. The FDA said it needs congressional and industry support to “build this system.”




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