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Will Johnson & Johnson put the Cancer Spreading Morcellator back on the Market? FDA Announces Black Box Warning

Will Johnson & Johnson put the Cancer Spreading Morcellator back on the Market? FDA Announces Black Box Warning

 

November 24, 2014

Who’s responsible if you get cancer? YOU

black-box-warning

Earlier this year, Johnson & Johnson decided to take the cancer spreading morcellator used to remove fibroids off the market.

The FDA estimates that 1 in 350 women who have fibroid surgery have an unsuspected uterine cancer.

The agency said on Monday it is recommending that a black box warning be placed on laparoscopic power morcellator devices used to treat uterine fibroids. Such an FDA warning is the strongest that a medication or treatment can carry while still remaining on the U.S. market.

Johnson & Johnson’s Ethicon unit, the biggest maker of morcellator devices, suspended sales of the device following the FDA’s advisory.

A spokesman for the company was not immediately available to comment on the FDA’s latest announcement. Yahoo!

Weird, Johnson & Johnson no longer provides a name of the spokesperson as they once did with the gold standard and mesh via spokesperson Sheri Woodruff.

JNJ Mesh vs Morcellators

JNJ doesn’t disclose morcellator sales, but they are a very small part of the health-care conglomerate’s overall business, which posted sales of $71.3 billion in 2013. WSJ

Johnson & Johnson earlier this year referred to the decision to “withdraw” morcellators with a rather dismissive tone indicating that the product did not impact their overall portfolio.  It will be interesting to see if Johnson & Johnson is again inconsistent & contradictory and decide to put the cancer spreading morcellators back on the market.  If they weren’t financially impacted by the decision what would motivate them to put the product back on the market, of course other than money.

Morcellators fast tracked

Medtech[y] The Wall Street Journal

If Johnson & Johnson decides to return their morcellator line to the market it won’t be done with a press release to the Wall St. Journal it will slink back on to the market trying not to get noticed. If the product returns the FDA should HAVE to send a press release out stating so. 

And the bigger question why is the FDA allowing the criminals to make the rules and why aren’t they protecting women?

JNJ Mesh vs Morcellators part two

What this means for you as a patient:

#Forced Accountability

Basically the doctors, the companies and FDA put responsibility on the patient. If a morcellator is used in a case now and a patient develops cancer (as previous patients have) your doctor, the medical device maker and FDA are not responsible. If it were me I would never allow a morcellator used for any procedure. Doctors may not like it, it may take longer in surgery or even for recovery but your health isn’t a numbers game.  You’ll hear things from the industry like, “it was all blown out of context,” or “I’m a better surgeon than those people who didn’t check margins properly,” but learn from the industries mesh victims and don’t take everything at face value.  There’s enough information out there now to be informed and make informed decisions regarding morcellators. Just because it’s available doesn’t mean we as patients have to accept it from the FDA or our doctors.

2 Comments
  • Doctors can use anything in the O.R. and you will never, never know unless you read the operative report AND/OR get your hospital records. Once they are done with you, YOU suffer the consequences!

    If the doctor knows the dangers of a device but uses it anyway, in some states you can not sue the company because of the “Learned Intermediary Defense”.

    The only duty the company has is to tell the doctor. And then if he/she has read about the risks someplace else and you are hurt,the company is still not responsible..

    Patients are basically out of luck if they get bad medical care, bad drugs or bad devices. The ” health care” system is rigged AGAINST ANY injured patient in favor of money in the pockets of the FDA, the companies, the doctors, the hospitals andthe attorneys.

    Best bet…don’t get sick and don’t have surgery! Even the simplest procedure or surgery carry risks, even death. Just think about what happened to Joan Rivers. What a tragedy. Sadly she is just one of thousands we never know about!

    November 24, 2014 at 5:14 pm

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