Davinci- what a scam

I'll let you know I'm here now.

 

great reviews and greater message!!

 

I have to say this was a amazing evening!!!
Couldn't be more pleased. Many good contacts made and new friendships!

 

Jury Awards Patient $2.2 Million in Defective Laparoscopic Instrument Design Verdict
Encision's Patented AEM Laparoscopic Surgical Devices Can Mitigate Such Injuries

Jan 25, 2011, 06:52 ET from Encision Inc.


BOULDER, Colo., Jan. 25, 2011 /PRNewswire/ -- Encision Inc. (Pink Sheets: ECIA) – A California jury awarded $2.2 million to a patient in a personal injury, product liability, defective laparoscopic device case against a competing medical device company; as reported in the Daily Journal (January 7, 2011, Verdicts and Settlements, page 7, Superior Court, San Diego, CA; case number 37-2008-00078376-CU-MM-CTL).

The San Diego jury found that the female patient received a stray electrosurgical burn to her bowel during her initial laparoscopic surgery which later perforated resulting in a severe intra-abdominal infection (peritonitis). "The jury returned its verdict, finding defendant liable under both product liability and negligence causes of action. The jury found that the defective and negligent design of laparoscopic device caused plaintiff's injuries." (Daily Journal).

Boulder-based Encision has developed patented Active Electrode Monitoring® ("AEM") laparoscopic instruments technology to prevent stray energy burns to patients from instrument failure or capacitive coupling during laparoscopic electrosurgery. Encision is the only manufacturer to offer this patient fail-safe feature in its laparoscopic instruments.

"There have been a number of warnings issued about the possibility of stray energy burns during laparoscopy, including scientific presentations at medical congresses and, in May 2010, the US Department of Defense issued its Patient Safety Analysis Center Alert, Stray Energy Burns from Laparoscopic Surgery," said Jack Serino, Encision's President and CEO. "These tragic complications beg for root cause analysis and preventive action."

Mr. Serino added, "Encision believes that stray electrosurgical burns are preventable by incorporating shielding and continuous monitoring into all AEM laparoscopic surgical devices, and that the majority of these types of injuries are technology related and not surgeons' technique related. The rationale for this claim is that these stray energy burns are occurring outside of a surgeon's field of vision which is produced by the laparoscope and displayed on a video monitor. Encision's AEM technology mitigates stray energy burns and protects patients, surgeons, hospitals and manufacturers alike."

 

https://m.dotmed.com/news/story/42700

 

https://m.facebook.com/story.php?story_fbid=1442091189235987&id=530024390442676

 

https://www.hollywoodreporter.com/review/bleeding-edge-1105081

Not a film you'll want to watch before undergoing a medical procedure.

Watch enough documentaries, and you'll find yourself having trouble getting out of bed in the morning. You'll certainly think twice before undergoing a medical procedure, especially on the heels of Kirby Dick's documentary about the hazards of so-called "innovative" medical devices. Chronicling the unnecessary pain and suffering of patients caused by complications of devices and procedures that received little or no testing, The Bleeding Edge is a terrifying eye-opener. The Netflix-produced documentary recently received its world premiere at the Tribeca Film Festival.

"When it comes to medical devices, we built a system that doesn't work," says David Kessler, a former FDA commissioner. The agency's mission goes back many years, as demonstrated by a vintage PSA featuring actor Raymond Massey that proclaims, "Help stamp out quackery!"

Dick (The Invisible War, The Hunting Ground) and producers Amy Ziering and Amy Herdy concentrate on just a few examples of the $400 billion medical device industry.

Another problem is robotic surgery, performed remotely by doctors who are too often insufficiently trained in the procedure. "The story of how the robot came into healthcare is the story of what's wrong with healthcare today," says a Johns Hopkins University professor. Several women describe undergoing hysterectomies performed by doctors using the "da Vinci robot" that went disastrously wrong. One of them suffered pain and bleeding for weeks before three feet of her colon literally fell out of her body.

It all boils down, naturally, to lax oversight and insufficient regulatory practices. The FDA's "Premarket Notification" system stipulates that a new medical device can be approved without testing if it is equivalent to an existing device — even if the prior device has been recalled.

Nine FDA scientists who expressed safety concerns about the agency's lax regulatory process were spied on and eventually let go. Meanwhile, the medical device industry employs an army of lobbyists and many FDA commissioners and other employees go to work in that industry after leaving the agency. Needless to say, things are only getting worse in the Trump era and under current FDA head Scott Gottlieb. Frighteningly, Gottlieb gained confirmation only after promising to recuse himself for one year from any decisions involving the no less than 20 healthcare companies for which he's worked.

The film concludes by informing us that no one from the FDA or any of the companies involved agreed to be interviewed. Their silence is both telling and infuriating.



Unplug the robot.

Oh Yes we can

-DWAS

 

and....what was someone saying about a “dearth” of reviews? I think they were MISTAKEN!!!

Let the truth be told....let it be heard!!

 

In contrast to the multitude of pre-premier posts hailing this film as a game-changer, there really hasn't been much said about it here. Seems like it was kind of a letdown compared to the build up.

 

No let down what so ever. Excellent!!
One more showing tonight. This is just the beginning!

 

Sorry to misinform my mistake. The showing is actually Thursday.

 

Intuitive Surgical (ISRG)
Price: $436.47
Morningstar Fair Value Estimate: $257
P/FV: 1.69
Average Analyst Price Target: $477
Intuitive Surgical makes robotic minimally invasive surgical products such as the da Vinci Surgical System. Regional equity director Alex Morozov believes the firm has dug a wide moat around its business through its expanding installed base of roughly 4,000 da Vinci systems and its vast procedure database.

Healthy system and instrument pricing reflects the firm's monopoly status in its niche, allowing Intuitive Surgical to achieve profitability rarely enjoyed by medical equipment makers, Morozov says. The firm's monopoly will sooner or later cease to exist, he says, as competitors move into the space, but as of now none of the emerging competitors have the potential to significantly disrupt the firm's operations or erode its returns on capital.


But while Morozov believes Intuitive's competitive positioning remains superb and the company still has a healthy growth profile, he thinks the firm will have trouble keeping pace with past growth rates.

"After a decade of explosive growth, Intuitive Surgical is becoming a victim of its own success, with tougher comps and challenges in its key procedures slowing its trajectory," Morozov said.

 

http://brightlightsfilm.com/dispatch-from-tribeca-3-the-bleeding-edge/#respond%23disqus_thread


This is the kind of cogent, well-researched exposé that, if activists weren’t tearing their hair out over Syria, North Korea, Bob Mueller’s investigation, Scott Pruitt’s cone of silence, global climate change, rampant gun violence, and lettuce poisoning, there might enough of an uproar to generate real reform.

* * *

Two weeks ago, under a concoction that my anesthesiologist dubbed “a Michael Jackson cocktail,” I had a medical device removed from my body.

A surgeon in South Bend, Indiana, pulled a threaded metal stick that held my foot in the proper position after bunion surgery. The bone is healed, and the metal was working its way (shudder) out the top of my foot, so like a pin on a grenade, I had it pulled.

I’m still hobbling, but after seeing The Bleeding Edge, I’m glad my foot didn’t explode.

I am one of 70 million Americans who have been implanted with metal, plastic, polymers, pacemakers, corneas, and more in the past decade. Most of us are wheeled to the OR with a high level of trust for the protocol that brought these devices into our operating rooms.

In the first few minutes of The Bleeding Edge, two-time Academy Award-nominated filmmakers Kirby Dick and Amy Ziering (The Hunting Ground, The Invisible War) offer a quick disclaimer, mentioning all the good things medical devices can do.

It’s the last nice thing they have to say.


Screenshot from The Bleeding Edge

The medical device industry is rigged to maximize profit, minimize safety, and – when things go wrong – to marginalize victims and silence the voices that might prevent further harm.

With a title like The Bleeding Edge, I expected disturbing images (there weren’t as many as I was bracing for, because the stories alone are horrific). I wasn’t surprised by the smug attitude of industry executives caught on tape, or the complacency of people in power.

The problem with The Bleeding Edge isn’t the gripping, well-paced, seamlessly produced, scary-as-hell content.

My concern is, in this crowded world of worthy causes, will the documentary produce enough buzz to generate reform.

This is the kind of cogent, well-researched exposé that, if activists weren’t tearing their hair out over Syria, North Korea, Bob Mueller’s investigation, Scott Pruitt’s cone of silence, global climate change, rampant gun violence and lettuce poisoning, there might enough of an uproar to generate real reform.

Especially now, how much outrage can a 70-minute Netflix documentary expect to generate? If enough people watch it, if enough tough questions go unanswered, there might be an election-year push for progress.

The Bleeding Edge highlights case histories of four types of victims: women who suffered permanent damage from Essure – a device marketed as a “simple, nonsurgical, permanent birth control,” an orthopedic surgeon from Alaska who suffered a mental meltdown after his metal-on-metal hip implants began leaching cobalt into his nervous system, a pelvic mesh patient who has lost track of how many surgeries she’s had to remove floating fragments (18? 19?), and several women who display remarkable dignity, considering their insides fell out, days after having DaVinci robots perform remote hysterectomies.


Da Vinci Robotic System. Image courtesy of Wikimedia Commons

Filmmakers Dick and Ziering let each victim tell their own story, not sparing the ripple effects on spouses, children, and careers. The presentation isn’t sappy or exploitive. It’s real life. We feel their pain.

None of these devices – from the eroding hip replacement to the pelvic mesh that stiffened internal organs – underwent rigorous testing, or required human trials, before they went into our bodies.

Like 96% of all medical devices on the market today, they were “grandfathered in” as part of the Medical Device Regulation Act of 1976.

As long as a manufacturer can point to a device that they claim is “substantially equivalent” to one that’s been legally marketed, it qualifies for PMA (Premarket Approval) under a provision called 510 (K). Even if, the documentary claims, the originally approved device was dangerous or ineffective.

If, somehow, it can be traced back to 42-year-old technology, as far as the Food and Drug Administration is concerned, it’s good to go (inside you).

There’s also a sick symbiosis between doctors and manufacturers’ sales reps, who offer legal kickbacks to surgeons.


Johnson & Johnson headquarters, New Jersey. Courtesy of Wikimedia Commons

I was upset to hear in passing that, while patients are under anesthesia, a salesperson from Johnson & Johnson, Stryker, or Medtronic is probably in the operating room looking over a surgeon’s shoulder offering installation suggestions, or maybe discussing a deep-sea fishing junket off the Gulf Coast.

Former FDA commissioner David Kessler (1990-1997) looks straight into the camera and admits, “We built a system that doesn’t work.”

Why has the US Food and Drug Administration gone along with this dangerous protocol for so long? Because the $400 billion medical device industry is one of the most powerful – and one of the more quiet – influencers in Washington, D.C.

The Bleeding Edge claims the industry’s lobbying arm, Advamed, bleeds green into campaign coffers, to the tune of $64 million in 2017 alone.

Current Commissioner of Food and Drugs Scott Gottlieb, MD, is a prime example of the industry/regulator revolving door. A former attorney for big device-maker Bayer, Gottlieb was accused of conflict of interest during his confirmation hearings. He was confirmed after offering to recuse himself from rulings that involved his former employer (and investment partner) for the first two years of his tenure.

As that sinks in, the audience is treated to photos of other former industry executives, alongside their positions with the FDA, and a frightening segment about whistleblowing research scientists who lost their jobs after suggesting that CT scanners, which can emit the equivalent of hundreds of X-rays in a single scan, might be better off with warning labels.

It may be no coincidence that three of the four nightmare scenarios Kirby Dick selected for his “doc doc” could only happen to women. I can’t help but wonder how the DaVinci robot executives would have reacted if, instead of a hysterectomy patient emerging from the bathroom with two feet of her colon in her hand, men began to report that their penises were falling off after surgery.

Though the documentary’s indictment of government and industry is damning, Dick and Ziering don’t mention one person who bears direct responsibility for the medical device nightmare. His name is Steve Austin.


Game based on The Six Million Dollar Man, 1975

The FDA isn’t the only one who is complacent when it comes to medical devices. Americans were conditioned, from an early age, to trust them implicitly, thanks to the character played by Lee Majors in the 1973-78 TV series The Six Million Dollar Man. (If ABC-TV revived the show, it would be The $48 Million Man.)

If anyone deserves a kickback from medical device manufacturers, it’s Austin, the fictional astronaut who lost his right arm, both legs, and his left eye in an experimental airplane accident. That incredibly popular TV show, and its spinoff, The Bionic Woman, convinced my entire generation that if something inside our bodies goes on the fritz – a hip joint, a bum knee, foggy vision – there’s a good chance that American ingenuity, dedicated government scientists, and selfless physicians could slice us open, replace the missing or defective part, and make us BETTER than we were before our mishap or disease.

The trouble with the FDA is that it’s working with regulations that were enacted back when The Six Million Dollar Man was still in production.

 

Praise Magnus for Kirby Dick and his brilliant film! The Prophet Magnus has promised the public revealing of the ISIS demons, and Mr. Dick has fulfilled the prophecy at last! I will pray to Magnus that Mr. Dick wins many awards and that the Bleeding Edge is noticed by the Motion Picture Academy. The Spirit of DWAS is unstoppable! Glory be to Magnus!!!

Amen

 

I do give many thanks to Kirby Dick, Amy Ziering and Amy Herdy. They have done a excellent job!
I hope this documentary is seen far and wide and I also hope it is a huge success!

 

Praise Magnus for Kirby Dick and his brilliant film! The Prophet Magnus has promised the public revealing of the ISIS demons, and Mr. Dick has fulfilled the prophecy at last! I will pray to Magnus that Mr. Dick wins many awards and that the Bleeding Edge is noticed by the Motion Picture Academy. The Spirit of DWAS is unstoppable! Glory be to Magnus!!!

Amen

 

Wow! 53 degrees seems rather cold to me to play golf! But don't worry, it will warm- up soon! Amitiza and I spent time at the lake earlier. The temperature here is in the mid- 60's, and it's supposed to warm- up to the upper 70's by this afternoon
VAGGIE

 

Intuitive Surgical knew patients were being burned through device arcing during their da Vinci surgery. They applied for a patent knowing this and saw their robot needed to be monitored for failures. They never implemented it. ISI also agreed their system needed to be monitored for stray currents and insulation failure because people were dying and being injured. Searching the FDA MAUDE database proves this.

https://patents.google.com/patent/US8551079B2/en

The risk of stray energy burns can be minimized and even eliminated through patented AEM® (Active Electrode Monitoring) technology. AEM instruments incorporate a‚ “shielded and monitored” design to prevent the risk of stray energy burn injury from insulation failure and capacitive coupling.

AEM technology consists of two primary components: AEM laparoscopic instruments and the AEM monitor. Whereas conventional instruments are simply a conductive element with a layer of insulation coating, every AEM instrument has a multilayered insulation design with a built-in “shield,” a concept much like a third-wire ground in standard electrical cords. The components of the AEM technology are as follows:

• The active electrode element is the central core of the instrument.
• The primary insulation layer withstands the high voltages needed to perform cutting and maintain hemostasis.
• The protective shield is a tube that surrounds the primary insulation layer. The shield conducts stray current from the active electrode back to the generator and away from the patient during surgery.
• The outer insulation, similar to that used on a conventional instrument, ensures energy containment within the shield component, even under primary insulation failure conditions.
• The monitor is attached to the generator and to the laparoscopic instrument. The AEM monitor is compatible with commonly used electrosurgical power sources. During electrode activation, the monitor continuously checks for primary insulation failure and prevents capacitive coupling. If the monitor detects a dangerous situation, it interrupts the power by shutting down the generator, alerts the surgeon and staff, and protects the patient from thermal burn injury.

Intuitive Surgical knew they needed aem but chose not to implement it. They chose to let all those people die and become injured instead of monitoring the device for arcing and allowed their robot to burn and kill all those innocent people!!

 

Not true.

 

It is FACT!!

Prove otherwise. You disagree with the patents ISI submitted or with the FDA?