Saturday, September 26, 2009

UPDATE on teen breast augmentation death: Florida state medical board finds no fault with doctors action


I just saw an update in the Miami Herald (here) on the events surround the anesthesia related death during breast augmentation of Florida teen Stephanie Kuleba, who underwent a fatal malignant hyperthermia(MH)reaction. This is a case I wrote about in Spring 2008 here & here.

Office based anesthesia is common for many procedures including oral surgery, dentistry, colonoscopies, otolaryngology (ENT), and plastic surgery. There's lots of reviews on this demonstrating outcomes and safety data comparable to hospital operating suites. Most plastic surgery procedures in this setting are on healthier patients, which can make a death more shocking.

Writing back then I said,
"I'm not sure what the take home message from this is. It's such a rare event that it's hard to justify having exotic protocols at all times in low risk procedures. Most office surgery suites maintain a supply of Dantrolene, a medicine to treat MH which is almost $2500 per dose and must be restocked often to stay current. There's plenty of adverse events more common then MH, but we don't have aortic balloon pumps or cardiac bypass machines routinely laying around for that. It already sounds like that the family has hired an attorney who is already assuming an aggressive posture in his comments to the media so I'm sure we'll see some legal proceedings even if perfect care for MH was instituted."


Predictably, the teen's parents in this case are still wanting their pound of flesh and have recently decided to proceed with medical malpractice lawsuits against her surgeon and anesthesiologists despite the Florida Department of Health finding there was no evidence of deviation of standards of care in this tragic event. Does that make any sense to anyone?

Rob

4 comments:

Barry L. Friedberg, M.D. said...

General anesthesia is a known trigger for malignant hyperthermia (MH) & is unnecessary for elective cosmetic surgery as amply demonstrated by the successful 17 year history of propofol ketamine (PK) anesthesia for all cosmetic surgeries, breast augmentation and tummy tucks included. There have been no deaths with PK anesthesia, unlike that from general anesthesia given to this unfortunate young woman. Simply because general anesthesia is safer than ever before does not make it the safest anesthetic achievable (http://drfriedberg.com/press-releases/cosmetic-surgery-pk-anesthesia-safest-achievable.html).
To proceed with general anesthesia without adequate supplies of Dantrolene is clearly an indefensible practice.

Michael C. Pickart, M.D., F.A.C.S. said...

This case illustrates why we need tort reform.

An unfortunate young lady dies because of a very, very rare familial condition. The same outcome may have resulted even if she were having a tooth pulled.

We--doctors and laypeople--are all horrified. I'm sure that the anesthesiologist and surgeon are very sorry.

What we all need to do is to have another good cry, and then take another deep breath.

And we should let our anger ebb away because there is no one to blame.

The death was a fluke of nature. The state medical board recognized that no one was at fault. And that should be the end of it. Let the family grieve, because they have no reason to be pissed off.

The only people who will benefit will be the lawyers. They'll charge $200-500 per hour to write briefs, file paperwork, etc., in order to make themselves richer.

The family's closure will be delayed...until they finally get no money. The doctors will pay a load of money to the lawyers, so that they don't have to pay an even bigger load of money to the family. Malpractice insurance fees will go up even higher, which will only threaten access to the people whose procedures aren't big money makers, because "Why should I risk increasing my malpractice fees if the pay off isn't even any good?!"

The whole thing is sickening. I liked Barack Obama, but it is unconscionable that he has refused to countenance tort reform as a significant part of his health care package.

eugene said...

Dr. Friedberg shouldn't be so intolerant of general anesthesia for breast augmentation. There is no consensus that general anesthesia is "unnecessary elective cosmetic surgery" Is there a randomized prospective study on PK anesthesia vs.general for aesthetic surgery that proves this? Or only the articles in Plastic Surgery Practice by Dr Friedberg as he is advertizing his "Goldilocks anesthesia foundation". This financial
interest, by the way, should have been mentioned in the comment.
Agree, however, that adequate Dantrolene is mandatory, and this is mandatory for AAAASF OR accreditation so should have been present.

narkose said...

For Eugene,

I am not intolerant of general anesthesia for breast augmentation.

However, I am intolerant of general anesthesia for ANY cosmetic surgery.

With a motivated patient, surgeon and OR staff, ALL cosmetic procedures, including tummy tucks and breast augmentation, can be performed under local anesthesia alone.

Nonetheless, most patients desire not to hear, feel or remember their surgery - a condition most often associated with general anesthesia.

BIS/EMG monitored PK anesthesia gives patients what they want from general anesthesia WITHOUT the deadly risks or nasty side effects; i.e. nausea, vomiting (PONV), pain or dementia.

There is no Level I RCT comparing the superior outcomes and safety of BIS/EMG monitored PK anesthesia BUT not for lack of world #1 PONV authority Christian Apfel designed protocol and my foundation's offer to finance it. No fewer than 7 universities have turned down the opportunity.

Absent the Level I study, what other validation is there for BIS/EMG monitored PK anesthesia:

1. Subsequent citation - 50% of all medical articles are NEVER subsequently cited by other authors.

No fewer than 60 articles & 12 anesthesia textbooks, including #1 textbook, Miller's Anesthesia, reference Friedberg's PK anesthesia.

2. Reproducibility - one object of a Level I study is to assure that this technique as described is reproducible.

Gradual titration of propofol to a numerically reproducible number (i.e. less than 75) gives a reproducible level of propofol hypnosis that prevents the negative, historically described problems from ketamine; i.e. bad dreams, rapid heart rate & increased BP.

If you check out the testimonial page on drfriedberg.com, you will find many physicians who have reproduced my outcomes (results)
using the hypnosis first, then 50 mg ketamine 3 minutes prior to stimulation.

3. Lack of medical malpractice claims - according to a major med mal insurer, The Doctors' Co., the average anesthesiologist gets sued every 8 years.

In the 18 years of performing PK anesthesia, I have never once been named, much less sued, by a patient.

4. Safety record -

In the 18 years of performing PK anesthesia, there has been not a single death, near death, 911 call, pulmonary embolism, or other airway mishap like aspiration or failure to maintain an adequate airway.

This experience was in over 5,000 patients of more than 100 different surgeons.

Other than BIS/EMG monitored PK anesthesia being more cost effective, safer, and better than general anesthesia, it also does not require an anesthesia machine, scavenging, or Dantrolene ($3K q3yr replacement cost alone).

As far as my work appearing in journals aside from 2009 Plastic Surgery Practice, my peer reviewed PK anesthesia articles are the following:

Friedberg BL: Propofol-ketamine technique. Aesthetic Plastic Surgery 17:297-300,1993.

Friedberg BL: Propofol-ketamine technique, dissociative anesthesia for office surgery: a five year review of 1,264 cases. Aesthetic Plastic Surgery 23:70-74,1999.

Friedberg BL: The effect of a dissociative dose of ketamine on the bispectral (BIS) index during propofol hypnosis. Journal of Clinical Anesthesia 11:4-7,1999.

Friedberg BL: Facial laser resurfacing with propofol-ketamine technique: room air, spontaneous ventilation (RASV) anesthesia. Dermatologic Surgery 25:569-572,1999.

Friedberg BL, Sigl JC: Clonidine premedication decreases propofol consumption during bispectral (BIS) index monitored propofol-ketamine technique for office based surgery. Dermatologic Surgery 26:848-852,2000.

Happy to send you my CV upon request. Many other non-peer reviewed materials including multiple chapters in different books.

Lastly, FWIW, one doesn't 'advertise' a non-profit foundation.
I created the Goldilocks Anesthesia Foundation to deal with the 'doubting Thomas' like Eugene.

Measure the brain, preempt the pain, emetic drugs abstain!