Bariatric Surgery Safety: More than your weight is at risk!

Posted on January 22, 2012 by K Eckland

Dying to be thin? These patients are… A look at the Get-Thin clinics in Beverly Hills, California..

This series from LA Times writers, Michael Hiltzik and Stuart Pfiefer highlights the importance of safety and the apparent lack of regulation in much of the bariatric procedure business here in the United States.

In these reports – which follow several patient deaths from lap-band procedures, both surgeons and surgical staff alike have made numerous reports against the ‘Get Thin” clinics operating in Beverly Hills and West Hills, California. These allegations include unsafe and unsanitary practices. One of the former surgeons is involved in a ‘whistle-blower’ lawsuit as he describes the dangerous practices in this clinic and how they led to several deaths.

Regulators ignore complaints against Beverly Hills clinics despite patient deaths – in the most recent installment, Hiltzik decries the lack of action from regulatory boards who have ignored the situation since complaints first arose in 2009!

House members call for probe into Lap-Band safety, marketing – California legislators call for action, but the clinics stay open. (article by Stuart Pfiefer)

Plaintiffs allege ‘gruesome conditions’ at Lap-Band clinics – mistakes and cover-ups at the popular weight loss clinics. (article by Stuart Pfiefer) This story detailing a patient’s death made me ill – but unfortunately reminded me of conditions I had seen at a clinic I wrote about in a previous publication.. The absolute lack of the minimum standards of patient care – is horrifying. This woman died unnecessarily and in agony. It proves my point that anesthesiologists need to be detailed, and focused on the case at hand.. (not iPhones, crosswords or any of the other distractions I’ve seen in multiple cases.. Now this case doesn’t specifically mention a distracted anesthesiologist – but given the situation described in the story above, he couldn’t have been paying attention, that’s for sure.

Are we jaded – or is it unsurprising that the lawyer for ‘Get Thin’ is a total slime, who was recently disbarred for attempting to bribe witnesses to suppress / change their stories about conditions at Get Thin clinics?

It looks like TAVI is here.

Posted on November 3, 2011 by K Eckland

The FDA recently approved the first TAVI device for aortic stenosis. Currently the device is only eligible for patients who are unable to withstand surgery. But who will end up making that determination? The cardiologist who will be implanting the device? At present – the company manufacturing the Sapien aortic device is recommending that patients be evaluated by a heart surgeon – but if this follows the typical course, I am sure that this recommendation will be abandoned as a matter of course.

Hopefully, the industry (interventional cardiology) will proceed cautiously, after being ‘omce bitten, twice shy” in light of the epidemic overstenting catastrophies.

For more on Aortic stenosis, TAVI and the overstenting controversies – look under the cardiology and cardiac surgery tab.

More criminal malpractice, and patient deaths: in my own backyard…

Posted on September 16, 2011 by K Eckland

Phoenix, Arizona –

In a case of criminal malpractice that sickens and horrifies health care personnel like myself – ‘self-proclaimed’ plastic surgeon, Peter Normann was able to delay sentencing after being found guilty earlier this summer in the deaths of three of his patients – in three separate incidents.

The details of each of the cases are quite frightening, and highlight reasons why trained observers like myself are critical for objective and unbiased evaluations for potential patients. In one case, another ‘homeopathic’ doctor working with Mr. Normann (not a licensed plastic surgeon) participated in a liposuction case that resulted in the death of a patient. In two cases – patients died because Mr. Normann failed to intubate the patients correctly (and tore the esophagus of one of the patients.)

In all cases, there was no intra-operative monitoring during cases – and Mr. Normann’s only assistant was a massage therapist (not an anesthesiologist, not a surgical nurse or trained surgical team.) Horrifying – completely criminal, and unforgivable and unacceptable.

Additional Links on this case:

Homeopathy in Arizona covered for doctors’ mistakes

‘Homeopathic’ doctor kills patient performing liposuction.

The Times: Surgical Roulette

Liposuction in a Myrtle Beach apartment

Posted on June 24, 2011 by K Eckland

Another case of sketchy plastic surgery reported – this time in Myrtle Beach, South Carolina. Yet again, I would like to caution readers about seeking ‘cheap’ plastic surgery on the internet. (I’m not saying don’t look – please do! But look smartly.) This doesn’t only apply to plastic surgeons, but to all surgeons, physicians, and healthcare professionals.

‘The internet’ is not all the same – the grade of information can vary widely from scientific journals (highly reputable/ reliable) to fiery but heavily opinionated blogs (unreliable/ unscientific) to frankly fraudulent such as in this instance (in the story above). People need to use caution, due diligence and common sense when researching anything, but particularly medical information on the internet. You need to do your homework.

There are a few things to consider when researching medical information/ providers on the internet.

1. Is the information independently verifiable? (and by what sources?)

As a medical writer – this is a huge portion of my job – verifying the information obtained during interviews, etc. But when you are looking to purchase goods or services – you need to do a little investigative work yourself. Luckily, once again – the internet makes this simple.

The first thing you should investigate is – the person making the claims/ and what their focus is. Use this website for an example, if you like. So take the following information (below) – that is easily available on the site..

(If this information isn’t readily available on the site – that should make you suspicious. “Anonymous” blogs or hidden author websites are NOT reputable. People with valid, truthful information have nothing to hide, and are not ashamed to stand by their work/ writings.)

so you’ve gathered the following information from the site:

Author – XXXX credentials claimed/ authority source: Physician (MD/ DO etc.)

Product or service advertised on the site: surgical procedure XX

Use this information to answer the following questions:

1. Who is this person?

2. How do they know this/ what special knowledge do they possess? (for example – a hairdresser shouldn’t be giving medication advice)

3. Can I verify this?

– Medical personnel can be verified thru state licensing boards.

Some states make this easier than others, but ALL states have this information available to consumers. So go to the website of the licensing board (medical board for doctors, nursing board for nurses) and look the person up.

In this example, I am currently licensed in several states – so pick one, and do an internet search for the board of nursing for that state. (Tennessee is particularly easy since they post educational information, license violations etc. on-line). If this licensing information isn’t easy to find on the website, call the board.**

If the website (ie. plastic surgery clinic) lists an address – use that state for your search.

In another example – as seen below – we’ve looked up a surgeon at the Colorado Medical Board.

Looking up a medical license

– All physicians should be licensed in the state of practice (where their clinic is.) If they aren’t licensed in that state – STOP and find another provider. Even if the doctor claims to be from another country, he or she is STILL required to have an active license in the state they are working in.**

Here is an example of physicians sanctioned by the Texas medical board (all of this information is freely available on the internet for your safety.)

Here is another example of a surgeon with multiple medical board actions against her.

license details

Many of the state medical boards will let you read the complaints, actions and disciplinary measures against physicians licensed in that state. However, some states allow physicians under investigation to ‘surrender’ or inactive their license to avoid having disciplinary measures recorded.

– All surgeons, or specialty doctors should also be listed with specialty boards – such as the American College of Surgeons, or the American Society of Plastic Surgery. (While membership is not mandatory, the vast majority of specialty trained surgeons maintain memberships in their specialty organizations.) Other things to consider while investigating credentials:

Do the credentials match the procedure? (Is this the right kind of doctor for this procedure?)

These credentials should match the procedure or treatment you are looking for: such as Plastic surgeons advertising breast augmentation.

This may sound obvious but it isn’t always the case. (for example: dermatologists shouldn’t be doing eyelid lifts or plastic surgery, primary care physicians shouldn’t be giving Botox injections, general surgeons shouldn’t be performing lung surgery etc.)
If you aren’t sure what procedures the doctor should be performing, look at the specialty surgery board – it should list the procedure. i.e plastic surgery and liposuction.

4. After verifying this information, it is time to do a basic internet search on the individual. To do this – perform both a Yahoo! and Google search. This should give you at minimum, 10 to 15 results.

These results should include several non-circular results. “Circular results” are results that return you to the original website, or affiliated websites. For example: Using the information from above – both Google and Yahoo! return several results that link directly to this website. These results also return links for the sister sites. All these of these are circular results – that return you to the starting point without providing any additional outside information.

However, if you scroll down the results: outside links should appear. These should include articles/ publications or scholarly work. Other search results may include more personal information, social networking sites and other newsworthy articles. This gives you a more comprehensive picture of the provider.

One of the things we should mention, is patient testimonials. While many providers include extensive patient testimonials, I disregard these for several reasons:

– There is usually not enough information to verify the authenticity of these patient claims. “I love my doctor. He’s a great surgeon.” – Gina S. doesn’t really tell you anything. In particular, there is no way to verify if there really is a Gina S. or if she is a fictitious creation of the website author. (There have been several cases where people working for the doctors have created ficticious accounts including before and after photos talking about procedures that they never had). Don’t be lulled into a false sense of security with patient testimonials.

– Some people use blogs, or message boards for the same purpose, and the same caveats apply.

– Another reason that patient testimonials are not useful in my opinion, is that patients (and their families) are only able to provide subjective information. Several of the cases in the news recently (of fraudulent individuals posing as doctors) had several “happy patients’ to recommend them. Patients, for the most part – aren’t awake and able to judge whether the surgery proceeded in a safe, appropriate fashion. The testimonials are merely a comment on the physician’s charisma, which may give future patients a false sense of security.

I’ve finished my search – Now what?

Use commonsense:

– Surgical treatments should be performed in an appropriate, sterile environment like a hospital or freestanding clinic. A reputable surgeon does not operate in the back of a motor home, a motel room or an apartment. (All of these have been reported in the media.) If the setting doesn’t seem right – leave. You can also investigate the clinic.

– Bring a friend. In fact, most surgeons will require this, if you are having liposuction or another large procedure. Doctors don’t usually drive their patients around (as was done in several recent cases.) The exception to this rule is medical tourism packages. These packages often include limousine transportation services but these services are provided by a professional driver (not the doctor, or ‘his cousin’). Your friend/ companion is not just your driver – they are also there to help feel out the situation. If something seems amiss – do not proceed.

– if the price is too cheap – be suspicious. If every other provider in the same location charges a thousand dollars – why is this doctor only charging a hundred dollars? Chances are, it’s not a sale – and he/ she is not a doctor.

– Use reputable sources to find providers – Craigslist is not an appropriate referral source.

– Are the claims over-the-top? Is the provider claiming better outcomes, faster healing or an ‘easier fix’ than the competition? (We will talk more about this in a future post on “miracle cures’ and how to evaluate these claims.

I hope these hints provide you with a good start to your search for a qualified, safe, legitimate provider. The majority of health care providers are excellent, however the internet has given criminals and frauds with an easy avenue to lure/ and trap unsuspecting consumers.

** The majority of cases that have been recently reported have taken place in the United States (Nevada, New Jersey, Florida and South Carolina.) Many of the people perpetrating these crimes have posed as Latin American surgeons to capitalize on the international reputation of plastic surgeons from South America. They also used these claims to try and explain away the lack of credentials. A legitimate doctor from Brazil, Argentina, Colombia, Costa Rica or another country, who is practicing in the United States WILL HAVE an American license.

Additional references/ stories on fraudulent surgeons.

(Hopefully this section will not continue to grow)

Plastic Surgery: Breast Augmentation news

Posted on June 23, 2011 by K Eckland

For all of my devoted readers, who have been wondering what I have been doing since I returned from my latest trip to Bogota:

Still traveling around, still interviewing surgeons whenever I get the opportunity. Today, I spent the day in the operating room in Fresno, California watching a very large cardiac surgery case (Aortic valve replacement/ Mitral valve replacement/ Tricuspid Repair (annuloplasty) with multi-vessel bypass) with Dr. Richard Gregory, MD, a native Fresno resident and cardiothoracic surgeon at St. Agnes Medical Center, in a Stanford affiliated surgery program. Today’s case seems to tie in (unplanned) with our previous discussions on valve surgery last week. It was a great – but complex case.

The facility is a private boutique specialty hospital; elegantly appointed with large, well-lit operating rooms. The surgeon was experienced and talented. Most importantly, the patient did beautifully.

All international/ national protocols followed with pre-operative time-out (which consists of several criteria to meet the National Surgical Quality Improvement Project (NSQIP) requirement. (More about this and the surgical apgar scoring system is detailed in Bogota! a hidden gem guide to surgical tourism). Sterility was maintained throughout the case – and the patient’s hemodynamic needs were promptly and properly addressed. Continuous Anesthesia / Perfusion monitoring through out the case.

Surgical Apgar scores not applied (not appropriate for this type of case.)

In other surgery news – this time, plastics and aesthetics – the Food and Drug Administration released a new statement today cautioning consumers on the use of Silicone breast implants. Previously, the FDA had attempted to limit the use of silicone-filled breast prostheses but had been met with significant resistance from groups of consumers who preferred silicone implants over saline filled implants.

In the article (re-posted below) the FDA states that while previous concerns regarding health complications related to the use of silicone implants such as silicone toxicity/ silicone poisoning have not been validated – the FDA cautions that over 20% of women will need to have their breast implants removed within ten years of implantation. This data confirms information provided during previous interviews with plastic surgeons, who stressed that breast implants are NOT a lifetime device, and several surgeons who stated, “Most patients will need the implants changed within ten years.” [notably, during these physician inteviews – the plastic surgeons were not specifically talking about silicone breast implants.]

Article Re-post: Medscape

Long-term complications likely with silicone breast implants

Mark Crane

June 22, 2011 — Silicone gel–filled breast implants are safe and effective when used according to their labeling, but the longer a woman has the implants, the more likely she is to experience complications, the US Food and Drug Administration (FDA) said in a new report released today.

“Breast implants are not lifetime devices,” Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said during a telephone news conference. “One in 5 patients who received implants for breast augmentation will need them removed within 10 years of implantation. For patients who received implants for breast reconstruction, as many as half will require removal 10 years after implantation.”

Women with silicone breast implants will need to monitor their breasts for the rest of their lives. To screen for silent ruptures, women should undergo magnetic resonance imaging 3 years after implantation, and then every 2 years thereafter, Dr. Shuren said. Women with saline implants do not need regular imaging.

When the FDA allowed silicone breast implants back on the market in November 2006, it required manufacturers to conduct follow-up studies to learn more about the long-term performance and safety of the devices. The FDA’s report is based on preliminary safety data from these studies, as well as other safety information from recent scientific publications and adverse events reported to the agency.

The most frequently observed complications and adverse outcomes are tightening of the area around the implant (capsular contracture), additional surgeries, and implant removal. Other complications include a tear or hole in the outer shell (implant rupture), wrinkling, uneven appearance (asymmetry), scarring, pain, and infection.

Studies to date do not indicate that silicone breast implants cause breast cancer, reproductive problems, or connective tissue disease, such as rheumatoid arthritis, the FDA said. However, no study has been large enough or lasted long enough to completely rule out these and other rare complications.

“Most women report high levels of satisfaction” with their implants, Dr. Shuren said.

The FDA is working with the 2 manufacturers who make silicone breast implants, Allergan and Mentor, to address the challenges in collecting follow-up data on the women who have received these implants.

Approximately 5 to 10 million women worldwide have breast implants. In the United States, 296,203 breast augmentation procedures and 93,083 breast reconstruction procedures were performed last year, according to the American Society of Plastic Surgeons. About half the procedures used saline implants, and half used silicone implants.

Patients with either saline or silicone implants may have a very small risk for a rare cancer called anaplastic large-cell lymphoma (ALCL) adjacent to the implant. However, the risk is “profoundly small,” said Dr. Shuren. “Since 1997, there are only 34 cases in the published literature, and at most 60 cases out of the 5 to 10 million women with implants worldwide,” he said. “We don’t yet know if there is a causal link.”

When the FDA first released information about the risk in January, William Maisel, MD, MPH, chief scientist and deputy director for science in the FDA’s Center for Devices and Radiologic Health, said the evidence suggests that the kind of ALCL found in conjunction with breast implants is less aggressive and is sometimes treatable by simply removing the implant, the capsule, and the collected fluid.

“The FDA will continue to monitor and collect safety and performance information on silicone gel–filled breast implants, but it is important that women with breast implants see their healthcare providers if they experience any symptoms,” Dr. Shuren said. “Women who have enrolled in studies should continue to participate so that we may better understand the long-term performance of these implants and identify any potential problems.”

The FDA is holding an expert advisory panel in the next few months to discuss how postapproval studies on breast implants can be more effective.

The FDA will issue an update at a future date on saline implants, Dr. Maisel said.

All serious adverse effects should be reported to the breast implant manufacturer and Medwatch, the FDA’s safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

Love, Life and Surgery in Latin America is now Colombian Culture & Cuisine

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