Patient Deaths Reported After Stomach Balloon Weight Loss Procedures

A recent Food and Drug Administration report reveals that 5 obesity treatment patients, who underwent stomach balloon placement, have died over the last 18 months.


The procedure takes about 30 minutes and costs about $3,000


Four of the 5 had what is called the Orbera Intragastric Balloon System inserted. The other underwent a procedure involving the ReShape Integrated DualBalloon System.

All of the patients died within 30 days of the balloon insertions, and several died in less than a week.

And doctors say they have no idea what went wrong.

The balloon insertion procedure involves placing either one or two un-inflated balloons through the patient’s mouth and into the stomach. Sterile salt water is then squirted into the balloons. The usual plan is for the balloons to lay in the stomach for 6 months. The result is that patients eat far less because they feel “full.”

The FDA says they are working to determine the exact causes of the deaths. They are looking into possible complications such as sudden over-inflation.

“At this time, we do not know the root cause or incidence rate of patient death, nor have we been able to definitively attribute the deaths to the devices or the insertion procedures for these devices,” the FDA said in a safety alert issued Thursday.

The FDA announced they are also investigating 2 other patient deaths, that could be related to possible complications of gastric balloon treatment. 

In those cases, there were accidental punctures of the throat and the stomach.

In total, there have been 21 known deaths over the last decade.

Here’s more from the FDA:

Most of the over-inflation reports involved the Orbera System that uses a single balloon, although some reports involved the ReShape Dual Balloon System that uses two balloons. Neither product mentions over-inflation risk. “At this moment there is not enough information to determine what is causing the balloon to overinflate.”

Other side effects involved sudden pancreatitis caused when the balloons compress other abdominal organs. Both the Orbera and ReShape products are associated with pancreatitis, Neither company lists pancreatitis as a potential complication. Pancreatitis was reported as early as 3 days after implantation, and symptoms included severe back and abdominal pain.

California State Agency Names Surgeons with Highest Patient Death Rate

“This is the first time California has ever reported the surgical mortality results for individual doctors. It will help patients choose better surgeons and a better hospitals, and will provide an incentive to improve quality care.” (Dr. David Carlisle, Director, Office of Statewide Health Planning and Development)  

As of this month, California residents can now learn the names of both hospitals and surgeons that score higher or lower, when it comes to cardiac bypass death rates. 


The Office of Statewide Health Planning & Development, which compiles statistics, now publishes coronary bypass death rates for 300 cardiac surgeons working at 120 hospitals. That’s the good news. The bad news is the most recent information covers surgeries performed in 2003-2004. In other words, the information is 14 years old.

The study was ordered by the California state legislature in 2003 and cost just under $2,000,000. It revealed that while 95% of California heart surgeons scored at, or about the expected, mortality average of 3% patient deaths, some performed considerably better, and some measurably worse.  As an example, Doctor Alexander Giritsky at La Jolla Scripps Memorial, was one of only 4 surgeons with the lowest heart bypass mortality rates. Not one of his 126 surgical patients died.

On the other end of the scale,  Doctor Jeffrey M. Rosenburg and Doctor Leland B. Housman were among the 12 physicians with the highest patient death rates. Rosenburg operated on 12 patients – 3 of whom died. Housman performed surgeries at Scripps Mercy in San Diego. Rosenburg operated at Palomar Medical Center Escondido. Housman operated on 140 patients – 9 of whom died during the reporting period.

By contrast, at Arcadia Methodist Hospital, a surgeon named Ismael Nuno tallied just under a 90% patient death rate.

About 400 patients each week undergo bypass surgery in California. Called a “cabbage” behind closed doors, the CABG procedure normally involves taking a blood vessel from the chest or leg and using it to create a new route for blood flow within the heart. 50% of these procedures are done on emergency patients.

It is important to note that dire surgical outcomes ought not be laid solely at the feet of the physicians. Some surgeons are quick to point out – and rightfully so – that their statistics are skewed from the start, because they are treating extremely sick patients to begin with, whose chances of surviving – especially in an emergency – are poor at best. Doctor Housman said it very well. “They died mainly because I accepted a mix of people who were older and sicker than most other surgeons are willing to take.”

Here’s another look:


The Indecent Assault of Advertising: In a Brighter Future It’ll be Criminal

Go ahead. Tell us. How much smarter the ads of today really are. How much healthier are we now, than we were then, because scamsters convince you to pop stuff into your mouth without thinking?



In some communities 40% of grade-schoolers are obese. Our chubby kid rate has gone up 300% since 1980. Can’t imagine why.




It doesn’t matter what your situation is, the toxin cartels are expert at convincing you that you have a problem , , , and they have the cure.

FEM HYGIENE   Facing divorce?  Simple fix: Lysol your genitals.   

CHICKS n BURGERS          How would YOU sell hamburgers?

Think these are wise ads for the mentally fragile to see? 

Vintage Ad Prozac





How much dumber are those, than this of today?




You’d have to be pretty darn naïve to believe the old stuff, right?



 Well, if it’s named after doctors . . . .


                    Yep. We’d never fall for these blatant manipulators these days

BEER Gardening ad





Who could fall for this idiocy?





Want the short answer?HEALTHY CIGS

You do. Your neighbors do. Your family does. Millions fall for nonsensical, manipulating advertising, every damned minute of the day. Why?

Because we are too mentally lazy to look up the truth, even when it’s right at your fingertips.

It has never been easier than right now, to wise up about what you put into your mouth, or allow in our homes.

Think about it.


We reap what we sow.

EKG art





Our Newest Social Disease? “Sensitivity Coma.” It Turns Smart Folks Into Idiots

The ‘Mind-Freeze’ Tolerance of Outrageous Behavior

Consider this:

18 months before the day the World Trade Center was destroyed, a civil service staff member at a Florida branch of the Department of Agriculture had an unnerving encounter with the Muslim leader of the 911 attack: 33-year-old Egyptian fanatic Mohammed Atta.


We can thank the idiocy of ‘cultural inclusion at all costs,’ for this

Atta had walked into her office one morning in May 2000 and ordered the woman at the desk to immediately issue him a loan for $600,000. “I need to buy a plane,” he said mysteriously. The woman was more than a little surprised, but told Atta there was a process involved in borrowing money from a U.S. government agency, and that process started with an application.

Atta exploded in anger. She was being unreasonable! Probably because he was a foreigner! How would she like it if he climbed over the desk and just took the money?

Mohamed Atta“Maybe I should just cut your throat with my knife.”

To her credit, the government employee remained calm and explained that her office did not deal with cash at all. Any and all transactions were issued by mail and by check. But it all started with an application of need.

While the frightening encounter was going on, as the woman explained to the FBI later, Atta noticed a large aerial picture on the office wall displaying sites of interest – such as the Lincoln Memorial – in the nation’s capital city. Atta demanded that she sell him the photograph. And when she explained it was not for sale, he went off on another bizarre tirade, threatening to blow up the landmarks and monuments in the picture. And it wasn’t long before he started asking her questions about the World Trade Center.

Now, a mental case walking into anyone’s office is troubling enough. But to our mind, what’s far more troubling is the mind-frame of the woman behind the counter.

I sensed the man was trying hard to make the cultural leap from his country to ours,” she told authorities.

Yes, indeed. She really did say that.

So, let’s peel back a few layers of this onion. A psycho ambles into your workplace unannounced and threatens to rob the company safe. He yammers that he needs to buy an airplane. He freakishly starts threatening to blow up government buildings and sites of historical significance. He blurts out that he could easily slash your throat. Did this educated professional government employee think it might be a bright idea to contact law enforcement and tell them . . . oh, we don’t know , , , what just happened?

She did not.

I felt bad for him, and was trying to make his transition into our society easier.”

Lord, love a duck you people.

This poor, apparently well-meaning lady, was so addicted to her “tolerance” of garbage-level behavior, that in her zeal to bend over backwards to accommodate immigrants – she failed to recognize her brain was tilted more to the Left than the Tower of Pisa.

And it hurts our mouth to report the mentally-challenged folks who think like this number in the millions.

In fact, so prevalent is it to remain “tolerant” of outrageous behavior at all costs – behavior that would shoot warning flares towards anyone capable of logical thought – that it is outright blinding us to the new normal: the zeitgeist of the group-think, “we have no right to be judgmental” nonsense.

Well, here’s a news flash: yeah, we really do have that right. In fact, we owe it to ourselves and our children. It’s called social responsibility.

In the end, this deliberately fragile-minded woman gets to live the rest of her life knowing that her inaction when it mattered – her visceral craving to be non-judgmental – rendered her wholly incapable of recognizing what a child could have seen: there was a shark in the town swimming pool.

Well, you know the rest, do you not? The following year, this same wild-eyed religious freak, Mohammed Atta, crashed a Boeing 767 into the North Tower of the World Trade Center, killing everyone on board. The crash led to the collapse of the tower, ultimately causing the deaths of over 1,600 civilians and first responders in the North Tower.

Oh, and that comment he’d made about slashing an American’s throat? He got the opportunity to do that, too – in the name of Allah, of course.

Moral of the story? Tolerance – taken to the extreme – is the skeleton of an adult with no ethical spinal column.

FDA Steps Out of it’s Drug-Adoring Comfort Zone. Mark it on Your Calendar

There has been an interesting development in the wide, wide, wicked world of modern medicine this month. The Food and Drug Administration has “asked” the drug cartel Endo Pharmaceuticals to immediately stop selling its slow-release tablets of a narcotic painkiller, which has been a serious moneymaker for the company since 2012.Opana ER

The drug in question Opana ER is a reformulation of oxymorphone, which is a synthetic form of morphine. The drug was originally marketed as a nasal spray in 2006. But abusers were finding it easy to snort and thus, overdose. Now there’s a news flash.

OPANA ER pillsAnd so, to make the drug delivery system safer, they combined the ingredients into an extremely hard tablet – resistant to breaking, crushing, dissolving or chewing. Even so, drug abusers are finding numerous, lethal ways to kill themselves with  Opana ER, which is far more powerful than morphine.

“After careful consideration, we are seeking removal based on concern that the benefits of the drug may no longer outweigh its risks. We are facing an opioid epidemic. It is a public health crisis, and we must take all necessary steps to reduce the scope of opioid abuse.” (FDA Commissioner Dr Scott Gottlieb)


This is the first time in history, apparently, that the FDA has moved to ban an already-approved opioid pain medication, due to consequences of abuse.


Think drug dealers see you as a human being? Think again

“We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse,” Gottlieb said.

“The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak. When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market.” (Janet Woodcock, MD, Director, Center for Drug Evaluation and Research)

So if Endo Pharmaceuticals chooses to obey the FDA “request” – that will result in at least ONE dangerous drug taken out of the public abuse-arsenal. Not to worry. There are still thousands more out there to pop into your goofy and gullible mouth. Just for fun, here’s a list of other, legal drugs that kill just about 300 of us every day of the year:

Political Correctness Insanity: The New York Times Won’t Use The Term ‘Female Genital Mutilation.’ They Don’t Want to ‘Offend’ The Mutilators.

Note: Here at Medical Miscreants, we very rarely republish articles by others. But this one, written by Immigration Law Expert Nolan Rappaport in Washington DC., is worth repeating. In fact, it should be yelled from the church belfry in every city in America.

Nolan Rappaport

Nolan Rappaport

The New York Times does not use the term “Female Genital Mutilation” (FGM) in its articles about a Michigan doctor who is being prosecuted for allegedly performing that procedure on two seven-year-old girls.  The Times calls the offense, “genital cutting,” despite the fact that the prosecution is based on a federal criminal provision entitled, “Female genital mutilation.”

If convicted, the doctor can be sentenced to incarceration for 5 years.

According to Celia Dugger, the Times’ Health & Science editor, “genital cutting” is a “less culturally loaded” term than “FGM.”  It will not widen the “chasm” between “advocates who campaign against the practice and the people who follow the rite.”

“For reasons that are inexplicable to me, Dugger seems to think that there can be a legitimate difference of opinion on whether it is right to mutilate the genitals of a seven-year-old girl.”  


The New York Times does not want to offend the religious maniacs who do this

Also, her euphemism, “genital cutting,” makes FGM sound less horrific, which is a disservice to the victims and to the people who are trying to stop the practice.

Political correctness serves a valid purpose when it prevents a person from unnecessarily or unintentionally offending others, but I do not understand why we should be sensitive to the feelings of people who subject seven-year-old girls to genital mutilation.  

What is FGM?

The World Health Organization classifies FGM into four major types:

  • Type 1: Often referred to as clitoridectomy, this is the partial or total removal of the clitoris (a small, sensitive and erectile part of the female genitals), and in very rare cases, only the prepuce (the fold of skin surrounding the clitoris). 
  • Type 2: Often referred to as excision, this is the partial or total removal of the clitoris and the labia minora (the inner folds of the vulva), with or without excision of the labia majora (the outer folds of skin of the vulva ). 
  • Type 3: Often referred to as infibulation, this is the narrowing of the vaginal opening through the creation of a covering seal. The seal is formed by cutting and repositioning the labia minora, or labia majora, sometimes through stitching, with or without removal of the clitoris (clitoridectomy). 
  • Type 4: This includes all other harmful procedures to the female genitalia for non-medical purposes, e.g. pricking, piercing, incising, scraping and cauterizing the genital area.

FGM is recognized internationally as a human rights violation.  It reflects deep-rooted inequality between the sexes, and it constitutes an extreme form of discrimination against women.  Also, because it usually is performed on minors, it is a violation of the rights of children.

How widespread is this practice?

The World Health Organization’s FGM fact sheet states that more than 200,000,000 girls and women alive today have been subjected to FGM in 30 different countries.  It usually is performed on young girls between infancy and age 15.

It has spread to Europe and other parts of the world too.  The European Commission estimates that hundreds of thousands of women living in Europe have been subjected to FGM and thousands more are at risk.  

The Center for Disease Control published a report in 2016 estimating that 513,000 women and girls in the United States were at risk of or may have been subjected to FGM in 2012.  This represents approximately a threefold increase from its prior estimate of 168,000, which was based on 1990 data.  The increase is attributed to a sharp rise in immigration from countries where FGM is practiced.  

The estimate probably is too low.  It does not include countries where FGM is practiced but for which there is no FGM information.  It does not include FGM data regarding undocumented immigrants either.  No one knows how many undocumented immigrants came from countries where FGM is practiced.

Reasons used to justify FGM:

In some communities, FGM almost universally is performed and is unquestioned.  It often is claimed to be a necessary part of raising a girl, and a way to prepare her for adulthood and marriage.  It is supposed to foster premarital virginity and marital fidelity, and thus increases marriageability.

FGM is associated with cultural ideals of femininity and modesty, such as the belief that removal of body parts that are considered unclean makes girls clean and beautiful.  In most societies where FGM is practiced, it is considered a cultural tradition.


According to GAO, there have been few FGM investigations or prosecutions.  Law enforcement and child protection officials told GAO that this may be due, in part, to the fact that incidents are not being reported.   

The prosecution of the Michigan doctor may be the first one.

The situation is no better in the United Kingdom.  Medical staff working in England’s National Health Service recorded approximately 5,500 FGM cases in 2016, but no one has been successfully prosecuted for performing FGM since the practice was banned more than 30 years ago.

This has to change.  It does not help to make FGM a felony offense if offenders are not going to be prosecuted. And the use of euphemisms like “genital cutting” that make FGM sound less horrific than it is, is yet another affront to the young girls and women who are forced to undergo the procedure.

Nolan Rappaport was detailed to the House Judiciary Committee as an Executive Branch Immigration Law Expert for 3 years. Prior to working on the Judiciary Committee, he wrote decisions for the Board of Immigration Appeals for 20 years. He also has been a policy advisor for the DHS Office of Information Sharing and Collaboration under a contract with TKC Communications, and he has been in private practice as an immigration lawyer at Steptoe & Johnson.


Here is our story in April: