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DarrylB

Robotic Surgery Warning by FDA!!

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DarrylB

My story is a dismal one, I should have been cancer free and was told absolute lies by my Urologist, yes I made a wrong decision whilst "drunk on the diagnosis"!

We who have been conned into robotic surgery may want to know the FDA's  (U.S Food and Drug Administration) latest warning 28 Feb 2019.

I was clearly given the understanding the robot was FDA approved!! and it wasn't !!!

https://www.fda.gov/medical-devices/safety-communications/caution-when-using-robotically-assisted-surgical-devices-womens-health-including-mastectomy-and?fbclid=IwAR32f8FyR1MrQyTaeGA7Ua2BRUiXWS_WFbibk91aYSjZGWo3H5bfmkorQ9c

GOOD READING and I am interested in what readers think..

 

all the best

DarrylB

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Paul

I had robotic surgery and the procedure was a radical prostatectomy in 2011 

It was a complete success 

 

The link above focuses mainly on women’s health

So I’m wondering 

Is robotic surgery approved for prostate cancer and not yet for other procedures???

 

 

 

 

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Bob

I underwent a radical robotic prostatectomy in 2018 for the removal of my prostate and surrounding tissue. 
The prior biopsy revealed that I had a high chance of having metastatic cancer, which is the case, that aside the robotic procedure was fine, my wallet on the other hand......
I wonder does Australia follow the US FDA completely or do we make our own analysis.

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Charles (Chuck) Maack

DarrylB: 

One should be cautious when addressing information to patients subject to prostate cancer.  You flatly stated "I was clearly given the understanding the robot was FDA approved!! and it wasn't !!! - you posted false information.  The reference you provide provides a recent FDA concern more specifically for women "for treatment or prevention of cancers that primarily (breast) or exclusively (cervical) cancer."   It’s primary further concern is that physicians who will be using robotic surgery for any cancer are thoroughly trained and experienced before beginning any robotic procedure, and patients are encouraged to question the physician as to his experience, knowledge, expertise, number of procedures already performed, and make certain this physician is qualified. These are concerns regularly addressed on these forums when we learn of a patient being recommended for robotic surgery.

 

From: “Robot-Assisted Prostate Cancer Surgery on the Rise:”

“The first robotic surgical system for use in urologic surgery was approved by the US Food and Drug Administration (FDA) in 2000, and the system was applied to prostatectomy procedures by 2001.

https://www.cancernetwork.com/prostate-cancer/robot-assisted-prostate-cancer-surgery-rise

 

From “Updates in Urologic Robot Assisted Surgery” last year:

“The current US Food and Drug Administration (FDA)-approved da Vinci™ platform is an SS system that uses the Si™ system

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6305212/

 

From . 2007 Jun;8(3):197-210.

Evolution of robotic surgery in the treatment of localized prostate cancer.

“Presently, 7 years after its approval by the FDA, many hospitals have established for robotic-assisted radical prostatectomy programs.

https://www.ncbi.nlm.nih.gov/pubmed/17721745

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ardee

I endorse Chuck's comments.

 

The takeaway point for me is that "overall survival, recurrence, and disease-free survival" compared to open RP may not have been adequately studied; not whether robotic RP is approved and reliable. I recall one study published last year that was inconclusive.

 

All surgery comes with risk .... there is no guaranty and plenty of examples of men who have had bad results from open surgery. Blaming the robotic procedure may be the wrong straw man. 

 

O&U, rd

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Patrick Turner
6 hours ago, ardee said:

All surgery comes with risk

The meaning of this is clear, surgery may or may not succeed to "get rid of your cancer" . It seems to me that very few men post here after having a successful open RP or a robotic RP and after finding their Psa went to zero and never ever rose again and they never needed follow up with EBRT, ADT, or a dismal battle with one potion after another for many years after, and, following the RP, their continence was OK and they had no ED and because they could keep their testosterone they had no bone density bothers, etc.

I was 62 when diagnosed  2009, Gleason 9. low Psa 6, but Pca at PG was found to be in-operable after they opened me up, in preference to earlier idea of using robotic, which would have also failed had the doc tried to use it.

Pca had probably already spread everywhere.  My Pca probably began 4 years earlier, and I should have been given biopsy in 2005 not 2009, but Psa was only 3, and so stupid medical system is not required to act on Pca until Pas goes to 5. I'd had Psa tests for 10 years, and expected to get Pca, but threshold of 5 is too high.

But even if my Pca had been caught earlier, when it was much less advanced, maybe not spread, surgery for RP is a risky thing because the distance from surgery to where cancer is in PG is very small, so it is very difficult for any surgeon to remove all cells containing PG DNA. If he removes all the cancer, but leaves a small amount of cells behind with prostate DNA, they may become cancerous over time. 

 

I met one man here who could see the risk, and had PG and bladder removed, and urethra cut short as possible well below PG, then had ureters joined and a stoma created so he'd wear plastic bag for rest of his life. No more getting up 5 times a night, and he didn't mind becoming instantly and permanently impotent. But he kept his balls and testosterone. It was an expensive op, but that's how he thought he could avoid the risk of normal treatment for Pca. He talked to me once about this, but never wanted to talk about it again. 

I'd guess this man paid a pile of dough for that op. He never said how much.

About 50,000 Australians wear a bag for liquids or solids or both. 

But there was still a risk for this man that his Pca had spread before that massive operation. 

This was well before any PsMa scan could detect spread earlier than any CT scan, so he took a huge risk because he still could have had Pca spread. 

 

Meanwhile, my Psa after having completed 4 x Lu177 shots in May is still going down, now 0.57, and well down from the high of 50 after 5 shots of Docetaxel failed last year. 

Seems like the pile of dough I spent on Lu177 was worth it. 

 

Life is a risk. Blokes get PTSD from life events, even without taking a bullet. 

I was told after the failed open RP that they'd give me ADT for 2 years, and EBRT after 6 months and that definitely would work. I looked up about it online, and thought the doc who told me that was A grade B artist. And for me, he was, because the ADT and EBRT merely tickled my cancer pink, and I found that docs at St Vincents thought the "ADT + EBRT" had a 90% fail rate for men with Gleason 9. So I soon got used to BS, but lived quite a cheerful life despite the false hope expressed by some docs along the way; my life was still a lot better than about 5 billion other ppl struggling and battling away on little blue Planet Earth. 

 

Lu177 is now being used earlier in progress of Pca, and it would have been ideal for me in 2009.

Its not approved. But its available where chemo fails. I did not dither about with chemo for long, I thought it would fail, so did my oncologist, and sure enough it did, and he had no hesitation to refer me to Theranostics Australia where I could buy the Lu77 for $40,000. 

But Pca will probably still kill me, because it tends to bounce right back like a weed in the garden that keeps coming back, despite trying to get rid of it. 

It snowed over last 3 miserably cold days here in Canberra but today skies are clear, and no wind, 14C and its another nice day of life above ground rather than below it. 

I'm going to prune my wisteria vine outside this afternoon, and am looking forward to Spring.

I might just live long enough for immune therapy to become more effective than it is, or for targeted chemo, in the same way lu177 is targeted. 

"Always look on the bright side"

Patrick Turner. 

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DarrylB

Hi All

Thanks for the comments, Forums like this are excellent in not only giving information for ongoing treatment but reviewing current or past practices. I have stored/saved so many future treatment options from this website that I will likely need but as one contributor wrote he was waiting on immunotherapy to arrive in Aus... and so am I.

I stand by by comment that my wife and I were lied to. We were promised that I would be back at work in two weeks... BUT!! and I would be cured once and for all!! and the list goes on and on... I was lead to all the robot manufacturers website links to absorb all the embellished perceived benefits.  We were told that I would only need one night in hospital (in 2010)... I was told by the hospital prostate cancer nurse a couple of years ago that 3 nights is now standard and I certainly would agree with that.

I was my surgeons 186th patient and I thought he was experienced enough - by what I researched at the time. I now understand 1000 is experienced enough and even then some surgeons never get out of the learning curve at all. I wont ramble as my story is on this forum for all to see.

Some months into the 2.5 year ordeal of multiple corrective surgeries I contacted Dr Bert Vorstman in Florida. He had some good articles to copy and distribute and I asked if I could do that. He agreed and asked about my condition, he replied that my case was not uncommon in the US.

To my surprise he turned out to be a Kiwi who was trained in NZ and later went over to the US to do more training and opened up his Clinic in Florida.

Dr Vorstman publishes many papers on prostate cancer and his latest article gives the history of surgery and robotic surgery with all the references.  He is very much a patient advocate and that is the point of difference.

His latest website article is on https://urologyweb.com/is-robotic-prostate-cancer-surgery-bad-health-advice/

 

I think you would agree that to make your way forward it is good to know where you are coming from......

 

Wish all of you well...

DarrylB

 

 

 

 

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Charles (Chuck) Maack

I found Darryl's referenced paper interesting in the history of surgical removal of the prostate relatively and reasonably explained.  However, the article though describing all the pitfalls of surgical removal of the prostate, never summed up what alternative treatment is recommended, and why that alternative treatment.  It always bothers me when reading everything wrong with something, but then the writer/author/complainer failing to follow-on with his/her recommended alternative and why that alternative is worth considering.  Why list a volume of pitfalls, but not have an option to be considered?  Worries us with “what now” then leaves us hanging!  I sent a contact request asking that very question but no response to now.

 

Charles (Chuck) Maack (ECaP) - Continuing Prostate Cancer Patient Since 1992, Advocate, Activist, Volunteer Mentor since 1996 to men diagnosed with Prostate Cancer and their Caregivers locally and on-line Worldwide.

 

 

Email: maack1@cox.net

Website: www.theprostateadvocate.com

My Efforts: https://tinyurl.com/yd8qz2os

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