Reply
Honored Contributor
Posts: 17,739
Registered: ‎03-09-2010

Re: The medical device industry and inadequate regulation resulting in harm

Why can't you put all of this stuff on one thread? Are you that desperate for attention that you must flood the forum with this stuff ,constantly?

Super Contributor
Posts: 305
Registered: ‎05-09-2010

Re: The medical device industry and inadequate regulation resulting in harm

In lieu of trashing Mindy D. because of your opinions (note that I said "opinions," not facts), I suggest that you consider applauding her for doing your homework. She cites only highly reputable medical oversight sources -- saving you the trouble of doing your own homework,  And, of course, there are occasional, fairly rare, flaws in the findings of these sources. There is far more misinformation in the popular lay press, which feeds on hysteria and caters to those who prefer simplicity and negativity in their  thinking processes.  

Esteemed Contributor
Posts: 7,172
Registered: ‎11-15-2011

Re: The medical device industry and inadequate regulation resulting in harm

[ Edited ]

No need to bash MindyD but she needs to understand that nothing is perfect in this world.  One TKR fails but 1,000,000 give someone a new life!  Where do you draw the line!  

 

Nothing, yes, Nothing suits everyone in the World, Nothing!  We are all the same but very different!

Trusted Contributor
Posts: 1,821
Registered: ‎02-16-2018

Re: The medical device industry and inadequate regulation resulting in harm


@Goldengate8361 wrote:

Medical device companies are, in fact, heavily regulated. This post is, unfortunately, not grounded in factual information.


@Goldengate8361  You are either in serious denial or seriously misinformed. People are winning lawsuits all over this country based upon faulty medical devices. Do the reaearch!  Metalosis on hip replacement ball joints whereby 

the metal from these joints is disintegrating and leeching into the blood. Hernia slings and medical mesh that are cutting into organs and damaging them, becoming dislodged and damaging other parts of the body.  Read this Consumer Reports article, “Dangerous medical implants and devices,

Most medical implants have never been tested for safety” at 

https://www.consumerreports.org/cro/magazine/2012/04/cr-investigates-dangerous-medical-devices/index...

 

Honored Contributor
Posts: 13,510
Registered: ‎05-23-2010

Re: The medical device industry and inadequate regulation resulting in harm


@Zhills wrote:

No need to bash MindyD but she needs to understand that nothing is perfect in this world.  One TKR fails but 1,000,000 give someone a new life!  Where do you draw the line!  

 

Nothing, yes, Nothing suits everyone in the World, Nothing!  We are all the same but very different!


Actually it’s 103,104 failures for the period cited in the chart found in this post. Zhills, I definitely do understand the expectation of error. I realize that with all the surgeries that happen, the risks of failures don’t always outweigh the benefits. Patients can’t expect zero risk with any procedure. Patients should expect risk. They also should be able to expect that safety regulations are adequate and that patients SHOULD BE INFORMED WHEN THEY ARE NOT. I just hope that members of this forum are as careful about shopping for a new body part as they are about shopping for a new skin cream. I’m just letting people know things they might not be aware of. As for me, if I were having an implant, I’d make an effort to find whatever I could about the device being employed. Much of this information is not open to public view and is also not revealed to the surgeons involved, so I might not be able to find out anything...but I would try. I rely on the adage, “It’s better to be safe than sorry.” Medical advancements are helping millions and for this I am aware and grateful, but I remain cautious.

Esteemed Contributor
Posts: 5,258
Registered: ‎03-10-2010

Re: The medical device industry and inadequate regulation resulting in harm

@Mindy D 

 

I could write a paper on the body of your piece, but won't.  Just know that many of the complaints refer to first generation devices, released to the general population.  Just as a first gen drug released to the general population, adverse reaction will or can go through the roof.  Sat on an IRB - been there, done that.

 

However, feel I need to address your closing statement.  When screws are used to hold a plate in place, a rep from the device company is in the O.R. with the surgeon and O.R. team.  The rep has, as his fingertips, all of the plates and possible screws necessary for the surgery.  Note:  There are 2 basic kinds of screws which come in many, many sizes.  The two kinds of screws are basically ones that are screwed in "forever." and do not come out.  However, there is a second kind, which can reverse thread out, which makes me wonder if this person  inadvertantly had a plate "fixed" with the wrong screws; i.e., the type of screw that can be removed (and, therefore, reverse itself out of the bone).  I chose not to use technical terminology here, so you'd understand what I was talking about.

 

In working with Ortho during surgical training, this subject was brought up time and again.  Our Residents are meant to take a look at, feel, and experience both types of screws in man-made bone, prior to using in donated specimens with Stryker drills.

Honored Contributor
Posts: 30,918
Registered: ‎05-10-2010

Re: The medical device industry and inadequate regulation resulting in harm

I don't know what your point is because all you did was clip something from somewhere and post it.  However, here in the real world, medical equipement and medical devices are highly regulated and they have to go through years of testing before they are approved.  Which is NOT to say that unfortunate and unplanned things cannot happen with any piece of equipment or any device.    Machines can fail for mechanical reasons or because of human mistakes and deficiencies.  Because nothing in this universe is perfect. As for drugs, you are wrong about drugs being stringently regulated a they were at one time.   

Esteemed Contributor
Posts: 5,882
Registered: ‎03-10-2010

Re: The medical device industry and inadequate regulation resulting in harm

[ Edited ]
  • I have asked Mindy if she has any expertise or certifications in the medical field; she has never deemed to answer.  Others have noticed what I have seen:  occasionally she hits the nail on the head (far more often she misses by a little or by a country mile!). I'm not a medical person but I read constantly and also multi task by watching t.v.  Usually, if there is a widespread medical alert (or recalled foods that MIGHT affect my area of the country are listed over and over again.  Just throwing (or cutting and pasteing) a **it lo** of ****** isn't the same as disseminating meaningful and useful information.  So Mindy if you are so interested in this (and throwing out *hit about "vaping didn't even address THC issue" because commercial vaping (as bought from Fast Strip -- not licensed dispensary)doesn't contain THC.
Honored Contributor
Posts: 13,401
Registered: ‎07-15-2016

Re: The medical device industry and inadequate regulation resulting in harm

[ Edited ]

I have an implant in my arm along with four screws.  Been there since 2003... no issues whatsoever.

 

----------------

 

ETA:  I know several people with pacemakers ... going back at least 20 years.  I haven't heard they had any issues.  My brother just got one a few months ago.

 

 

Esteemed Contributor
Posts: 5,460
Registered: ‎07-10-2011

Re: The medical device industry and inadequate regulation resulting in harm

I have two plates and eight screws in my neck (2 Cervical Spine Fusions 2003 and 2004) and they are still there and don´t expect anything different.