Endo Fecal Incontinence Device Warning

Why women? Why was this device tested on women ONLY? Did the women already have a pelvic implant? Was that the reason of the fecal incontinence? Which doctor put these women in this trial? These are questions we should have answers. Beware of these implants because your LIFE IS AT STAKE!

Fecal incontinence is so bad no one wants to talk about it. When I cleaned up after my husband I had a terrible time facing it. I can give you awful stories that will make you wretch, but there is no point. Imagination alone is enough to get the point.

For the women who are dealing with it because of their medical mesh implants, they can’t talk about it either because everyone they know will run from them. These women are intelligent with careers. They aren’t street people who don’t care, they care very, very much. They can’t talk about it with family because no one wants to know about these things. The very idea is gross and they will be looked at in a very different way. Not with love, but with pity and disgust. So they stay silent. But they know they can tell me anything and it is a relief for them to tell someone. Someone who want turn away with disgust. Someone who will write about it in a way to get the point out there.

I am very, very fortunate not to have this problem along with all my other problems caused by medical mesh, but I know many women who do. Some have explained to me what they have to do to make sure they have everything on hand no matter where they go, in case of an accident. One of them sent me a link this morning because she was so upset at what she read. She told me she does have this at times and it was caused by her AMS/Endo bladder sling. She struggles, but she went back to her career even though her life is in shambles. She has to figure out how to get through each day at work, because she cannot afford to live on disability. So what upset her so much about what she read? I called up the link to find out and once I read it, I can understand why. What I read seriously disturbed me enough that I immediately began writing a blog to warn others about this new device.

We all know the FDA approves implants, drugs and products with very little testing or none at all. Mesh could not be tested EXCEPT when placed in the human body and then it was TOO LATE. Removing it is difficult and only done completely by a few doctors who are capable. We don’t take removal lightly, but we do it because of the HUGE HEATH RISK of leaving it in our bodies. But it was NOT INTENDED to be removed and therefore our tissues come out with it. Then we need more surgery and more repairs. We will NEVER be the same again. Do these companies care? No they don’t. They will make millions from any product and it is next to impossible to get it recalled. By that time years have passed and so many people are damaged, often to the point of death.

Fecal incontinence is terrible. I watched my husband go through it after radiation for prostate cancer. Leaving the house could be a nightmare, but he took Imodium anti-diarrhea pills daily and it controlled it so he could continue to live. I would NEVER have let him do something like this because his immune system was so badly compromised by radiation and this would have been terrible and probably the end for him. That was eighteen years ago and my husband died twelve years ago next month.

I want you to read some of what I read and then I am going to give you the link to read it all. First I want you to understand that this trial was done on WOMEN ONLY.

The independent experts voted 8-0 that the Endo’s second-line Topas System demonstrated a reasonable assurance of safety and efficacy, and that its benefits outweighed its risks, meaning that they think it should be approved.

During the device’s clinical trial, 105 of the 152 female patients (69%) who were implanted with the Topas experienced at least a 50% reduction in episodes of fecal incontinence. The median number of incidents per day fell from 18 per day to 5 per day as of the 36-month follow-up.

Why women? We all know that women are suffering terrible side effects from medical mesh implants. It cost. $299.00 for the product and hundreds of thousands of dollars for the damage it does and to remove it. Please don’t take that chance.

Patients in the trial had failed conservative therapies like dietary modification, medication and pelvic floor muscle training, in line with its proposed second-line indication.

According to Medscape, some panel members expressed concerned that the trial was on the small side for a PMA device and had a single-arm design. The FDA wrote in its executive summary of Endo’s application that it approved the trial in 2009 because it did not think there was an appropriate control treatment available.

Some panel members expressed concern? Why did they approve it then? They won’t take any responsibility for the injured people who have problems from life so why are they on the panel.

Regarding safety, 50 of 115 participants (43.5%) reported pelvic pain at the 3-year follow-up. But the panel members said the risk was acceptable given the debilitating nature of fecal incontinence. “I would trade off pain to having to wear a diaper,” Barbara Berney, a consumer representative on the panel, said, according to Medscape.

Remember the name Barbara Berney because this woman is a cold horrible person who has no idea what pain is like. I say put one of these in her in HER and see how she does. Better yet, let’s give her a sling first.

In addition, 13 of 115 of the women (11%) in the trial reported de novo or worsening pelvic organ prolapse at the 3-year follow-up, but the panelists said it probably occurred due to disease progression and not the Topas device or implantation procedure.

Who decides your fate of prolapse and eventual surgeries to fix them? It seems these people do!

Perhaps the biggest safety concern among the panelists is the spectacular failure of vaginal mesh implants, which have drowned their makers in lawsuits (including Endo, though most are now settled) and injured thousands of women.

“When mesh implants were approved, everything looked great. Now look where we are,” panelist Dr. Terrell Hicks said, according to MedScape, who is concerned about long-term safety issues that weren’t captured by the trial, due to its duration.

No they are NOT concerned about safety at all they are concerned about how much money it will cost them because of lawsuits. It is all about money. How much can they pull in before they have to pay out for damages!

So how is it implanted?

The Topas is implanted below the anorectum through two small incisions in the thigh and buttocks. It is believed to reduce fecal incontinence by providing anatomical support to the anorectum, thereby restoring the 90-degree angle between the axis of the rectum and the anal canal, according to FDA’s executive summary.

OMG it is another disaster waiting to happen. More damage done when trying to remove an implant that sticks to tissue and grows to colons. More colons removed. More bags placed in women because they are so BADLY DAMAGED and their colons were removed.

You may wonder how they get this crap through the FDA. Make a note of 2007 version. What happened with that one? Remember, they constantly come out with new slings which are variations of all the others.

Endo applied for approval of the Topas in April 2014, but FDA asked for more information, resetting its one-year clock for making a decision, MedScape reports. It is not available in any other country. A previous version of the device was 510(k)-cleared by the FDA for pelvic floor repair in 2007.

Okay after reading this I am also so upset. How can they keep doing this to women? I tried to find a photo of this device but none were available.

This is the full article

1 Comment

  1. Don't remember

    I saw this the other day somewhere, I have been busy while being sick all week and thought you knew about it. Nevertheless, now you do. I was literally sickened by what I was reading! We who have mesh already deal with the biggest fear of this mesh eroding INTO our colon, so what now? We just wrap it up in mesh and tie a bow on it and hope??? The thing that stood out to me was one of the panelist observed in her pea brain that anyone would rather have this than wear diapers all the time!! I will tell you this I would rather have a colostomy bag hanging on my side before they would put mesh intentionally around my colon,, intestines or anything else down there! That is how bad the mesh is!!! Diapers would be the absolute least of your problems, not to mention that reading between the lines you can have this done but YOU WILL STILL BE WEARING A DIAPER FOREVER! I am so incensed by this new show of affection from the mesh – makers, I could puke!!! It just makes my heart fall to my stomach and I absolutely sure I am not the only one! The worst part is….. how can or could we even try to make a pr-emptive strike against this? Sadly I don’t have the answer! But I thought living in the United states would offer that right, somewhere!! GREED, GREED, GREED!!! Another round for the manufacturers, doctors, hospitals and lawyers!! That is where the greed is! Please ….someone tell me the doctors will JUST SAY NO!!!! That is all they had to do on the mesh debacle going on now! They will take a weekend course to be flown to New Orleans or Vegas to learn it in a weekend!!


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