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Dear Johnson & Johnson: Pay for Your Mistakes

Ethicon  200Johnson & Johnson (JNJ) grabbed headlines this week for withdrawing from the market power morcellators, manufactured by subsidiary Ethicon, citing uncertainty” about the “risk-benefit assessment” associated with the device’s use. Just as important was the demonstration that the company is willing, in some cases, to do the right thing. This action renews hope that JNJ will make a similar determination about its pelvic mesh implants, which are also manufactured by Ethicon.

The withdrawn morcellator device is commonly used in uterine surgery to remove fibroids by cutting the tissue into tiny pieces and extracting it through small incisions. Uncertainties about the device’s safety surfaced in April 2014, when the FDA issued a safety communication stating that morcellators could spread cancerous tissue in women with undetected cancer, presenting a risk that the procedure could “significantly worsen the patient’s likelihood of long-term survival.”

Clearly, this device presents a danger to patients, and JNJ was right to voluntarily withdraw it from the market. Still, the decision raises questions about the company’s handling of a product manufactured by the same subsidiary and intended for the treatment of common pelvic disorders in women: pelvic mesh.

Criticism of pelvic mesh is not new. Three of the largest manufacturers of pelvic mesh face more than 65,000 lawsuits, with JNJ’s subsidiary Ethicon accounting for more than half of this total.

A July 2011 FDA Safety Communication identified the frequent complications associated with pelvic mesh, including mesh erosion through the vagina, pain, infection, bleeding, organ perforation, and urinary problems. The safety communication specified, “Many of these complications require additional intervention, including medical or surgical treatment and hospitalization.” Far from conveying ‘uncertainty’ about the dangers of pelvic mesh, the FDA also stated that serious complications are “not rare.

New Brunswick, New Jersey, April 2014

New Brunswick, New Jersey, April 2014

Last week, the FDA closed a comment period on a proposal to reclassify pelvic mesh for pelvic organ prolapse as a Class-III, high-risk device. In a demonstration of the overwhelming support for the measure, the patient advocacy group We Are Mesh Survivors submitted hundreds of separate comments gathered in just three days from mesh-injured women and supporters urging the FDA to authorize the reclassification.

In April, a group of mesh survivors traveled to the JNJ Annual Shareholders Meeting to address CEO Alex Gorsky directly about their concerns.

“Mr. Gorsky, you hurt me,” said Teresa Sawyer of Toledo, Ohio, who has had four corrective surgeries to remove the mesh since it was implanted in 2011. “I started having massive infections and strange immune conditions.”

Morcellator, courtesy NYT

Morcellator, courtesy NYT

While Johnson & Johnson is not the only company manufacturing this product, it is the industry leader and has a reputation for ensuring that mistakes are paid for,” as stated in its famous Credo. Johnson & Johnson should follow its own example: in the interest of ensuring the safe and effective use of its products, the company should withdraw pelvic mesh from the market before any more women are seriously injured.

 

11 Comments

  1. msm says:

    Another “Gynecare” product ? “Wedon’tcare” would fit it better. Again the cart is put before the horse in the name of profits. The FDA allowed ON-MARKET testing again using women as guinea pigs. When will the Federal Government get their heads out of the sand and realize that the FDA policies and procedures must be overhauled? These 510K products should be pulled from the market and fully investigated as other more progressive countries have done.

  2. All Meshed Up says:

    When is the FDA going to have independent testing and not rely on the Manufacturer of the Medical Device to tell them how “Great” it works? The FDA has been allowing public testing of Mesh products for a long time. Just ask a Hernia Mesh Victim that had to deal with the first Prolene meshes. Like, Me! Or how about the Bard/Kugel Hernia Patches with the Retaining ring with ‘welds’ that would break thereby lacerating every thing around it? Public testing gone bad? Most testing was done on sheep and that was only for a few months. Then to be ‘kind’ to the sheep they took it out. Then they started putting Hernia Mesh in humans, permanently. Who at the FDA thought that a few months in a sheep was just as good a test as being permanently installed in a human? I mean, really? This is just sick………

    • msm says:

      PETA would stand up for the animals. Too bad we don’t an equivalent for humans. Sick. Regardless on feelings about socialized medicine, at least there is a vested interest in the health of citizens. Let people get hurt and the government has to foot the bill forever. That’s why they’re smart enough to ban use pending further testing while we leave it on the market and victims fend for themselves while the manufactures “test” their own products on more patients who fall victim. USA is the most progressive and highly educated country? OBVIOUSLY NOT ! Just the country whose government exists for the benefit and protection of manufacturers, banks, etc. whose profits benefit the top 1%. I’ll stop my rant. Sorry about that….

    • Judy Valent says:

      No one wants to talk about the suffering of the bad damage done by Mesh on men and women. I never dreamed that no one can get help from something that is slowing killing people or talking their life from them. This is so evil! Companies, doctors, manufacturers, FDA, it is time to take responsibility with this epidemic. If you watched your family member go through this hell on earth, you would scream until someone took responsibility and stand by the medical oath. We need a “Million Mesh March” in front on the White House, MAYBE someone would listen.

  3. All Meshed Up says:

    Rant? You call that a RANT?!! I’ll give you a rant…….It’s OK msm! I think ranting is just another one of the myriad of symptoms of a Mesh Implant. lol!

    Best Wishes………

  4. DEBORAH says:

    I AM SO TIRED OF JNJ DRAGGING THEIR FEET! HOW MUCH LONGER DO WE WAIT, ARE THEY WAITING FOR A CERTAIN AMOUNT OF US TO DIE?

    I AM 4 YRS. INTO THIS ETHICON JOKE! SEEMS THE JUDGE WOULD MAKE A MOVE, I DO NOT UNDERSTAND, THEY HAVE FOUND ETHICON TO BE AT FAULT, AND HAVE AWARDED FOLKS, BUT THEN THERE ARE THE OTHER CASES, WHAT IS THE DIFFERENCE?

    I HAVE 5 DOCTORS WHO HAVE DIAGNOSED THIS AS EROSION AND ALL THE OTHER STUFF IT IS DOING, PENETRATING INTO OTHER PARTS OF MY BODY, ETC.

    I DO NOT SEE HOW THE COURT NEEDS ANY MORE INFO ON THIS DEADLY MESH!

    • All Meshed Up says:

      You are one of many thousands of Mesh Victims that are in limbo over their cases. There are Hernia Mesh victims that have been waiting for 7 years for their “Substantial Settlement” from the Motley Crew. They cannot get any further info as to the when and how much of a settlement they so desperately need. Some of the victims did not agree with the pittance they were offered and are now being ignored by their Lawyers. Some victims who were initially identified as a tier 1 or 2 are now being asked if they will accept a tier 4 or 5 settlement which cuts their monies to a third ( if not less ) of what they expected. The Lawyers are wanting more of the Substantial Settlements for themselves. You would not want them to miss their Mercedes payment or their Fiji vacation would you?

      From everything I have heard and read about these supposed substantial settlements is that YOU are categorized by the Court as to your damages and the Manufacturers Lawyer either agrees or not. But what seems to be happening is that what you expect, according to what you are initially told, is being negotiated down but the whole of the Settlement remains the same amount. The Lawyers now make more money. 40% of EVERY VICTIMS settlement adds up to a lot of money but the victims who have waited and suffered for years and will suffer for the REST OF THEIR LIVES are screwed. Why are there so many TVT Mesh Lawyer advertisements on TV? Because they are making a boat load of money off of our suffering. And I do not give a damn what a Lawyer says in his defense because the end result of their settlements is what tells exactly what they are about. MONEY. Not your financial security. Not your health or general well being. What they are about is THEIR bottom line, not yours. Motley Crew, Mark Mueller, Migliori and the Patterson Group ( Austin Tx. ) are no better than vultures or the proverbial “ambulance chasers”. They may have to wait it out just as you do before they make, literally, Millions of dollars. But the difference being is that YOU will NOT get a million dollars and you are still suffering from the effects of a mesh gone bad for the rest of your life! Mean while the Vultures are still trolling for more Mesh Victims.

      Until the FDA bans or recalls ALL Mesh products, we will be the cash cows for the Doctors, Manufacturers and Lawyers that continue the fraud and deceit of Surgical Mesh.

    • Kitty says:

      Deborah—-Barack Obama doesn’t seem to have much interest in the man that was beheaded by Ices—why would he care about women who were implanted with a toxic chemical device? Michele Obama worked for a hospital that did considerable business with J & J. I believe that J & J contributed to their cause.

  5. angela says:

    HELP! My o.b.g.y.n has removed the mesh john an Johnson bladder sling.i keep going down,Cant get out of bed,2days a week I get up hour or two. And that’s it.In a wheel chair,was walking with limp got around good before surgery .have a disability,But was happy,Cry all the time my thyrepst said I lost my identity,The doctor who took out the sling thinks I should be fine.wont fix my bladder said he is afraid I will come after him,I am desperate for a doctor who knows about the sling problems.and I have Medicaid.only good in ky, The state I live in .I m getting weaker everyday.Iam scared.NEED a doctor bad.After sling removal.my boewls dnt work ,I have a stomach stimulator in my stomach it stopped working ,my stomach that is, And I am so weak every day is worse the sling has poisned my body.How do I get better?I just want my life back, I feal like I wont make it much longer,Is there a doctor near Muhlenberg county kentucky that can help me.If anyone can help me please I beg for help.in past 3 and half years I have only left home to go to the doctors.and none has helped .they don’t understand,the sling is gone the damage goes on .SOMEONE HELP PLEASE ! I am so weak,no energy at all move around little clothes soaked in sweat, I am lost,stuck,afraid,scare,lonley,in constant pain.so confused,The poison in my body from the sling that was suppose to make my life better,It could not be worse.Can anyone help me,Is there HOPE?

    • Jane Akre says:

      Angela….. have you seen dr ali azadi in Louisville? Clearly you are not fine and I’d like to know the name of the doc who said that…. thank you. Anyone in KY who has a suggestion for angela?

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