What Big Pharma Is Saying Behind Your Back As It Tries to Sell You Defective Medical Devices

Categories: Healthcare

meshskull2.jpg
Johnson & Johnson is known as the family company. Except for when it sells defective medical implants that destroy patients' genitals.As I reported in last week's feature story, over 17,000 women, including some in Dallas, are suing Johnson & Johnson and its subsidiary, Ethicon, for its transvaginal mesh products.

The mesh, made out of polypropylene plastic, was promoted to doctors as an easy, non-invasive method of curing stress urinary incontinence and pelvic organ prolapse, two conditions that are common in aging women who have given birth. But it turned out that the product's benefits for many patients were outweighed by nasty side effects.

Patients and doctors complained that the mesh would break into pieces, erode out of place through other body parts (use your imagination) and cause intense pain.

With the lawsuits, thousands of internal company documents and emails have been turned over to attorneys and are now public record. We dug through those documents and found many cases in which J&J/Ethicon appeared to know about problems the product caused, yet simply didn't care. The worst examples are below. (If you want more context, read whole feature).

"Major damage control offensive needs to start to educate the reps and surgeons UPFRONT that they will see BLUE shit and it is OK." -- Dan Smith, from research and development under Ethicon's Gynecare brand, responding to concerns that blue plastic particles were falling off the mesh in the operating room

"I ACCEPT THAT WE NEED TO REPORT THE CASE OF DYSPAREUNIA BECAUSE I WOULD AGREE IT WOULD BE UNETHICAL NOT TO MENTION SINCE WE KNOW ABOUT IT. HOWEVER THE WAY IT IS PRESENTED IN THE ABSTRACT IS GOING TO KILL US." -- Kimberly Hunsicker, Ethicon's Research Operations Manager, figuring out how to downplay the side effect of dyspareuina, a.k.a. painful sex, caused by the products

"There is no reason to expect that the fraying of the mesh or the particles generated would create any safety risks." -- Marty Weisberg, Ethicon's Senior Medical Director, telling everyone not to worry about the mesh fraying into pieces through patients' bodies

"Need to learn more about special anatomic features in the vaginal region." -- company notes from a 2007 "brainstorming session" with surgeons

"Problem: Vagina is very odd-shaped, so you cannot use a preformed implant."-- More notes from that same session. All very comforting words coming from vagina doctors!

"They [surgeons] maintain that mesh is sometimes used in cases where it is not necessary by an enthusiastic but less skilled general gynecological surgeon." --Company notes after meeting with a different group surgeons. Suddenly, surgeons no longer seem so impressive.

"I just had a concern about your statement concerning Potential Complications/Fistula &Erosions. This is a problem which arises rather commonly in practice even with polypropylene and it might be wise to be more elusive on this." -- Dr. Axel Arnaud, Ethicon's medical affairs director, looking for ways to not discuss fistulas in a product report. Fistulas, by the way, are when the skin between the anus and vagina gets torn. It's a complication that patients would probably like to be warned about before getting the mesh.

"To preserve the sexual life, it is essential to:
- preserve the suppleness of the vagina
- avoid irritating spikes."
-- notes from a company powerpoint on making mesh softer. We totally agree with these points. However, they do seem rather obvious.

"... There are a few studies that have attempted to characterize the properties of the human vagina."-- A company 2011 report put together by scientists Jürgen Trzewik and Christophe Vailhe, talking about all science studies in general. Apparently, the human vagina has been studied a little bit, but not a lot. Thanks, science!

"Of course, we ultimately need to know what is happening in the human female." -- Trezewik and Vailhe, again, making another obvious point.

"A recent major focus of mesh development and research is the patient's quality of life." -- Also from that Trezewik/Vailhe report, which remember, was published in 2011, over a decade after the product was first brought to market. Better to focus on the patient's quality of life over ten years too late than not at all.


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17 comments
JjrkCh
JjrkCh

Read the J&J "credo"  http://www.jnj.com/sites/default/files/pdf/jnj_ourcredo_english_us_8.5x11_cmyk.pdf

on their website. 


It is all about the return to shareholders with lip service to the safety and effectiveness of their "innovative"  implanted medical device products and the lives of the patients who may be catastrophically and permanently harmed.  Nothing personal:  it is just business!


My blog:  Failed Implant Device Alliance


Thank you, Amy Silverstein and Dallas Observer for being in the media forefront of covering this scandal!

The_Mesh_Warrior
The_Mesh_Warrior

Thank you AMY!!! Great follow up work. Thank you, thank you for telling our stories. This is such important news. Thank you for using your talents to write the truth.

Rooster0620
Rooster0620

Actually Genius...I believe it's SC Johnson that is known as the family company...

www.scjohnson.com

Does anybody edit this thing?

Myrna.Minkoff-Katz
Myrna.Minkoff-Katz topcommenter

Big Kitty was right to refuse the Vet's lap band recommendation. 

ozonelarryb
ozonelarryb

Basement tinkerers cobbling up lunatic devices, commisiones salesmen flogging them to pliant doctors, mgmt covering up.

but who needs regulation, except to limit damage awards.

holmantx
holmantx topcommenter

Similar mesh failure in the second most common surgical procedure for men - inguinal hernia repair.  It also spurred a lot of class-action lawsuits after the Composix Kugel Mesh hernia patch was recalled (ouch!).

TheRuddSki
TheRuddSki topcommenter

@ozonelarryb

I imagine this product had to run a gamut of regulations, etc to get to market.

The_Mesh_Warrior
The_Mesh_Warrior

Yes- polypropylene mesh is also used for hernia repair in men and women. Class action is not the kind if suits that are being filed for transvaginal mesh. The suits are entered into the federal MDL, overseen by the Hon. Judge Goodwin in West Virginia (multi distict litigation). In this type of litigation, different than a class-action suit), each case is considered individually, using its own specifics, evidence, individual plaintiffs' injuries & health issues. Awards are not divided equally, but rather, based on the damage or injury in each specific case & plaintiff.

The_Mesh_Warrior
The_Mesh_Warrior

5/5- good work AMY & DO team. It is not easy to pour through all those documents to find the information! VERY SINCERELY, THANK YOU!

oakclifftownie
oakclifftownie

@ScottsMerkin @ThePosterFormerlyKnownasPaul

2/5ths of the missing vagina is the problem

The_Mesh_Warrior
The_Mesh_Warrior

Sadly @ozonelarryb. Look up the FDA's 510k Process. No human trials or Tier 1 Ethics double blind studies required. FDA Approval is wholly different than FDA Clearance. Please educate yourself before you are harmed.

halfofhart
halfofhart

@TheRuddSki This product was slid in under 501 as being so similar to products used that it did not require testing

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