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FDA: Robotic surgery "unapproved" for cancer

Tamlen's picture
Tamlen
Posts: 192
Joined: Jan 2018

I'd posted a link to some research published last fall that cast doubt on the wisdom of robotic hysterectomy from a cancer spread / survival length point of view. I think that link got lost in the hacking/crashi this site had a few weeks back.

But apparently the FDA had similar concerns about that research:

"Patients and providers considering robotic surgery for cancer-related procedures such as mastectomy should be aware that currently available devices are not necessarily as safe or effective as conventional surgery...One particular publication got the agency's attention: a "limited 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)." (The agency didn't specify the publication; a PubMed search for "long term survival cervical hysterectomy robotically assisted" yielded only a single hit, from 2010.)

"In this report minimally invasive surgery appeared to be associated with a lower rate of long term survival compared with open abdominal surgery; however other researchers have reported no statistically significant difference in long term survival when these types of surgical procedures are compared," citing a November 2018 New England Journal of Medicine report. (Preliminary results were presented earlier last year at a meeting.)"

"...In essence, the agency advised patients and providers that using robotic assistance devices for oncologic purposes is poorly charted territory. Surgeons in particular should make sure patients understand that, and should discuss alternative treatments so patients can make informed decisions, the FDA urged."

I had robotic DaVinci and loved the short recovery time. I'm not loving it so much now, thinking about the role it could have played and may still play in the spread of my cancer.

Read more here: FDA: Robotic Surgery Unapproved for Cancer

SF73
Posts: 276
Joined: Oct 2017

Ouch! Both my surgeries were laparoscopic. Within three months of the original hysterectomy I had a recurrence on my ovary. Even though I gave permission for the doctor to perform an open surgery he did the minimal invasive again. Hope we didn’t take an unnecessary risk.

zsazsa1
Posts: 343
Joined: Oct 2018

I have worried about this, too.  The recovery from laparascopic was quick and easy.  But I was worried that the surgeon couldn't actually palpate the nodes, as they might have at an open surgery, and that all I had taken were 2 sentinel nodes, one of which had isolated tumor cells (UPSC/clear cell).  I remember having seen that study after the surgery, but if was only for cervical cancer.  I know my surgeon was doing the best she could, to weight the risk of the misery of lymphedema after the surgery if she took all the nodes, vs the known improved survival with surgical debulking taking all the nodes.  Our records are all going to be part of a retrospective analysis, I'm sure, down the road, to see if open vs lap hysterectomy and staging in uterine cancer shows the same results as with cervical cancer.

paris11
Posts: 159
Joined: Oct 2010

Six months later the cancer had metastasized thru out my body.  I was given less than a year to live.

MoeKay
Posts: 215
Joined: Feb 2004

You may find this article on the subject interesting:  https://cancerletter.com/articles/20181102_1/

With respect to endometrial cancer it states:  "We’ve all been so focused on decreasing the morbidity from surgery and improving patients’ quality of life, and we’ve had studies in other cancers including endometrial cancer that showed no impact on outcome in doing minimally invasive surgery.”  (emphasis added). 

 MoeKay

Forherself's picture
Forherself
Posts: 221
Joined: Jan 2019

Of Information.  Thanks for sharing this.   I have only read studies that showed minimally invasive procedures compared to open surgery for endometrial cancer showed no difference in survival.   Our cancer is so rare it is hard to get evidence either way.  I think that it would be nice for the CDC to address this issue for endometrail cancer patients.   it will be very interesting to follow this.   As said before, we are all members of the retrospective cancer study group.  They will follow us all and learn.

BluebirdOne's picture
BluebirdOne
Posts: 198
Joined: Jul 2018

https://www.mdanderson.org/newsroom/minimally-invasive-surgery-associated-with-worse-survival-for-women-with-cervical-cancer-compared-to-open-hysterectomy.h00-159228090.html

I read this a few months after I had my robotic surgery and was immediately depressed.  They stopped performing them. 

I can't believe that the robotic surgery for hysterectomy produces a different outcome. Most of the women here I believe have had the robotic surgery.  

 

Forherself's picture
Forherself
Posts: 221
Joined: Jan 2019

My surgeon asked me to sign a consent for both procedures pre op.  She decided my uterus was too big to remove per vagina (on the operating table) as I had never had children.   I was never able to become pregnant.  So I had both robotic puncture wounds, and a suprapubic incision.   I did not have any problems with recovery.   This was before October when this article came out.

BluebirdOne's picture
BluebirdOne
Posts: 198
Joined: Jul 2018

I had two previous C-sections and they did not know what they would find like adhesions etc. I would  only learn post op. 

EZLiving66's picture
EZLiving66
Posts: 1357
Joined: Oct 2015

I had robotic surgery and, knock on wood, have had no recurrence. My recovery time after surgery was, I swear, a few hours. I literally dance out of the hospital the next morning and could have gone back to work if I would have had to.

Love,

Eldri

Soup52's picture
Soup52
Posts: 902
Joined: Jan 2016

After having two C sections I found robotic hysterectomy much easier. I had also had a kidney removed 10 + years ago with minimally invasive surgery. So many have robotic now and I had mine October 2015 and I’m still kicking with no reoccurance.

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