Davinci- what a scam

Seek mental counseling and find a friend lonely loser rat

 

You must find it interesting. You constantly monitor and troll this page. Rookie

 

As I said before - ISI reps LOVE strawman tactics. It’s sad, but dwas humors them because we feel sorry for them and let them vent. Poor things...

 

Why are isi reps suddenly posting again—-

Hmmm...

A. was a new lawsuit filed?? Worried about something, csrs?

B. A new field notice sent out?? Another noncomforming material recall? GMP Trouble in Easton again?

C. Fda blew the whistle on your nonsense and is making your hidden adverse events public now?

D. All of the above

 

True Dat!

 

D

 

There are thousands of adverse events that have been stored in a hidden database with the fda.

Hiding adverse events from the public means no real informed consent could have been obtained due to FAILURE TO WARN.

https://www.google.com/amp/s/khn.org/news/hidden-fda-database-medical-device-injuries-malfunctions/amp/

Failure to Warn in Strict Products Liability Lawsuits
Strict products liability is the rule governing consumer product injury lawsuits in most states. Under strict product liability, the defendant is held liable for product defects regardless of whether the company or business acted negligently.

Intuitive Surgical paid 43 million to settle this lawsuit.

“The cases involved shareholders who purchased stock between February 6, 2012 and July 18, 2013. Shareholders claimed that the company and a select number of its officers violated federal securities laws by “making false and misleading statements and omitting certain material facts in certain public statements...”

How much to settle the new or soon to be filed cases due to the same misleading and deceptive reporting practices?

 

All true! Intuitive is on double-secret probation with the FDA. It’s going to be over for them very soon.

 

Don’t trust a company who will sue their own founder. #noloyalty #nointegrity

 

“A manufacturer or distributor of a product must provide warning labels on products for off-label use issues or the potential risks if using the item in a certain way. “

ISI trolls - please provide a cited reference to your off label warning for hospitals and clinics warning of the use of the robot in procedures for cancer or cancer related/preventative indications. (How many women with high risk hpv strains had their cervix removed during a hysterectomy for cancer prevention?)

Per the FDA notification:
Audience:

• Health care providers who perform robotically-assisted procedures as part of cancer prevention or treatment

The relative benefits and risks of surgery using robotically-assisted surgical devices compared to conventional surgical approaches in cancer treatment have not been established.

...report that compared long term survival after radical hysterectomy for cervical cancer either by open abdominal surgery or by minimally invasive surgery (which included laparoscopic surgery or robotically-assisted surgery). In this report minimally invasive surgery appeared to be associated with a lower rate of long term survival compared with open abdominal surgery...

To date, the FDA has not granted marketing authorization for any robotically-assisted surgical device for use in the United States for the prevention or treatment of cancer

https://www.fda.gov/medical-devices/safety-communications/caution-when-using-robotically-assisted-surgical-devices-womens-health-including-mastectomy-and

 

“Between January 2016 and December 2018, the FDA received 32 medical device reports referring to cancer and the use of robotically-assisted devices. Four of these reports in the publicly available MAUDE database3 described patients who died undergoing hysterectomies after their cancers spread. A fifth patient treated with a robotic device sustained serious injury.”

https://www.cancertherapyadvisor.com/home/cancer-topics/general-oncology/robotic-treatment-cancer-fda-calls-patient-registries/

 

no the surgeon never even mentioned why it was converted. never knew about it until after I started digging into medical records

 

At one of the hospitals in my area the Da Vinci sales rep is actually dating one of the surgeons. This particular surgeon has been trying to increase robotic cases through out the hospital network since they started dating the rep. They even altered the residency curriculum at the hospital and have been pitching to senior management to upgrade to the latest model robots, which they did. This is all of financial benefit to the sales rep/their significant other. Unbelievable that it goes unchecked.... Does anyone know if this kind of situation is common?

 

This is not uncommon from what I have read on other message boards.

Report this to the state’s medical board, and cc the hospital’s risk management department and intuitive Surgical. Explain the concerns you have of the credentialing of the surgeons and patient safety due to this ethics and compliance potential breach.

Also ask in your correspondence what the credentialing is at the hospitals in question and if they have been awarded a Center of Excellence in Robotic Surgery achievement or if they have applied. If they have applied and have not been granted this award, ask why.

You can look up the doctors on https://openpaymentsdata.cms.gov/

 

“The most famous Pfizer rep to describe a doctor-sex story is Jamie Reidy, formerly the self-proclaimed No. 1 Viagra salesman in the U.S. (Reidy was later fired as a sales trainer from Eli Lilly when his book, "Hard Sell," was published. The book detailed his unethical sales tactics while at Pfizer and Was made into a movie, Love and Other Drugs”

 

Even SeekingAlpha is pessimistic:
“investors have been extrapolating rosy prospects a bit too much, awarding a too high valuation to the business to see an appealing risk-reward from here onward.”

 

Recommendations for Patients
Before you have robotically assisted surgery to prevent or treat cancer:

• Be aware that that the safety and effectiveness of using robotically-assisted surgical devices in mastectomy procedures or in the prevention or treatment of cancer has not been established.
• Discuss the benefits, risks, and alternatives of all available treatment options with your health care provider to make the most informed treatment decisions.
• Before choosing your surgeon, we recommend asking the following questions:
  • Ask your surgeon about his or her training, experience, and patient outcomes with robotically-assisted surgical device procedures.
  • Ask how many robotically-assisted surgical procedures like yours he or she has performed.
  • Ask your surgeon about possible complications and how often they happen.

 

Recommendations for Health Care Providers

• Understand that the FDA has not cleared or approved any robotically-assisted surgical device based on cancer-related outcomes such as overall survival, recurrence, and disease-free survival.
• Be aware that robotically-assisted surgical devices have been evaluated by the FDA and cleared for use in certain types of surgical procedures, but not for mastectomy.
• The FDA recommends that you take training for the specific robotically-assisted surgical device procedures you perform.
• Talk to your patients about your experience and training, and the clinical outcomes expected with the use of robotically-assisted surgical devices.
• Discuss the benefits, risks, and alternatives of all available treatment options with your patients to help them make informed treatment decisions.
• Be aware that clinical studies conducted in the United States involving a legally marketed device investigating a new intended use are subject to FDA oversight. For further information, please refer to the FDA's Investigational Device Exemption website.
• If any of your patients experience adverse effects or complications with a robotically-assisted surgical device, we encouraged you to file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

 

All great questions to ask before any surgical intervention, robotic or otherwise....