Surgeon Operates on the Wrong Child

How did this even happen?

            by Skeptical Scalpel MD

A newborn in Tennessee had an operation to correct a "tongue tie." Except for the procedure being performed on the wrong baby, things went well.
According to reports, a nurse came into the mother's room and took the baby. The mother assumed that the child was having some routine nursing care and was understandably upset when the nurse returned and said the baby was fine after the operation.
The frenulum is a fold under the front part of the tongue.

Normal frenulum

When it is too short, tongue tie results. It can cause immediate problems with feeding and with speech and alignment of the teeth later in childhood. The surgery is usually done without anesthesia and consists of simply cutting the shortened frenulum to release the tongue.
This link from Stanford University has before and after photos of a newborn with tongue tie.
Tongue tie is common, occurring in 4% to 10% of babies, and serious complications of the corrective surgery are extremely rare.
How could this mix-up have happened?
It appears that the doctor accidentally sent for the wrong patient.
The nurse who fetched the baby either did not ask anyone why he was having a procedure and/or did not know the baby's history very well.
Before starting any invasive procedure in most hospitals, a "timeout" is done. It consists of a checklist with the following: 1) the correct patient is confirmed by using at least two separate identifiers; 2) the procedure to be done is agreed upon by all participating medical personnel; 3) a consent form signed by the patient or a legal guardian is in the record; 4) all necessary equipment is available. I will wager that a root cause analysis will find that a proper timeout did not take place.
The pediatrician who did the operation apologized, but the family has retained a lawyer and is threatening to sue.

In order for a malpractice suit to succeed, four conditions must be met.
A doctor-patient relationship must have existed. In the tongue tie case, the doctor presumably had a relationship with the mother and the baby.
Negligence must have occurred. Operating on the wrong baby fulfills that criterion.
The negligent act must have caused the injury. So far, so good.
Significant damage must have resulted from the negligent act. One report said "Nearly 2 months have passed since the surgery, and the infant appears well enough, although he does make gagging sounds at times, while lying on his back, and other times has trouble during bottle feeding."

I have several children and grandchildren. Every one of them had occasional gagging and difficulty feeding as a baby. Proving with medical certainty that cutting the frenulum caused these problems would be difficult.
However if I were representing the doctor or the hospital, I would try to settle this case as soon as possible. Even though the damages are probably insignificant, the negative publicity surrounding a trial would outweigh the possibility of winning the case.
One more thing. Why didn't the doctor notice that the child about to be operated on had a normal frenulum?
Skeptical Scalpel is a retired surgeon and was a surgical department chairman and residency program director for many years. He is board-certified in general surgery and critical care and has re-certified in both several times. He blogs at SkepticalScalpel.blogspot.com and tweets as @SkepticScalpel. This post originally appeared at Physician's Weekly.

Most ESRD Patients Not Referred for Transplant

Georgia study is first large-scale effort to examine referral rates

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• by Jeff Minerd 
  Contributing Writer, MedPage Today

 
• This article is a collaboration between MedPage Today® and:
   

Action Points

Only about one in four patients with end-stage renal disease in Georgia were referred for kidney transplant evaluation by their dialysis facility from 2005 to 2011, according to a study published in theJournal of the American Medical Association.

Of those referred, only about one in five made it onto the national deceased-donor waiting list, reported lead investigatorRachel Patzer, PhD, of Emory University in Atlanta, and colleagues.

"For most of the 600,000 patients in the United States with end-stage renal disease (ESRD), kidney transplantation represents the optimal treatment, providing longer survival, better quality of life, and substantial cost savings compared with dialysis," Patzer and colleagues wrote.

"Despite these benefits, kidney transplantation is not available to all patients with ESRD, owing to the paucity of available organs, as well as long-standing racial/ethnic, socioeconomic, sex, age, and geographic disparities in access to kidney transplantation," the investigators said in the report.

A referral for evaluation at a transplant center is usually required to begin the transplantation process, but the proportion of patients referred in the United States is unknown. There is no source of national data on referral rates, Patzer told MedPage Today.

Patzer and colleagues decided to investigate referral rates in Georgia, the state with the lowest kidney transplantation rate, in order to shed some light on this issue. "This study is unique because no one has ever looked at data on this level before," Patzer said.

The investigators collected data on more than 15,000 adult patients with ESRD at 308 Georgia dialysis facilities from 2005 to 2011. The data were obtained from the United States Renal Data System. The researchers then linked this information to kidney transplant referral data collected from transplant centers in Georgia during the same time period.

The study found that 28% of the ESRD patients were referred for transplantation within one year of starting dialysis. Referral rates varied widely across dialysis centers, from 0% to 75%. The median within-facility percent of patients referred was 24%.

Compared with dialysis facilities with the highest rates of referral, those with the lowest rates were more likely to treat patients from high-poverty neighborhoods (absolute difference 21.8%; 95% CI 14.1% to 29.4%; P<0.001), to have a higher patient to social worker ratio (mean 61.2 versus 38.8; P<0.001), and to be non-profit (difference 17.6%; 95% CI 7.7% to 27.4%; P=0.001).

Patients not referred were more likely to be older (difference 5.7 years; 95% CI 5.3 to 6.1; P<0.001), to be white (absolute difference 5%; 95% CI 3.4% to 6.6%; P<0.001), and to be female (difference, 3.8%; 95% CI 2.1% to 5.6%; P<0.001).

Of the patients referred, 21.5% were put on the donor waiting list within one year of their referral. The factors associated with referral were often not the same as those associated with being waitlisted, the researchers noted. For example, sex and age were not significantly associated with waitlisting, and black patients (versus white) were less likely to be waitlisted (OR 0.77; 95% CI 0.64 to 0.93; P not reported).

"These finding may have implications for health policy makers, researchers, clinicians, and patients. Low facility level referral for transplantation, as well as the variability in referral across Georgia facilities, suggests that standardized guidelines are needed for the content and duration of a patient-clinician educational discussion regarding treatment options at start of dialysis," the researchers concluded.

"The 28% figure seemed low to us," Patzer told MedPage Today. "There aren't any absolute contraindications to transplant. Given that transplant is the best treatment option, we would think the majority of patients would be referred."

Having more patients referred and put on the waiting list for transplant would not necessarily just increase the wait time for a limited supply of donor organs, Patzer argued. "It's not a zero sum game," she said.

For example, eligible patients would have the option of trying to find a living donor among family or friends. And transplant centers might be more aggressive about the organs they select, she said.

"Nephrologists, social workers, and nurses in dialysis facilities should be having conversations with patients about transplant as early as possible. The earlier you can get a referral, the better," Patzer said.

Increasing referral rates may not be enough to ensure better patient outcomes, said transplant surgeon Dorry Segev, MD, PhD, of Johns Hopkins University, and colleagues in an editorial.

"In light of these findings, efforts to improve access should not only focus on improving rates of dialysis center referral for kidney transplantation but also on identifying and targeting barriers for the 80% of referred patients who ultimately did not achieve access," Segev and colleagues wrote.

"These findings underscore the complexities involved in obtaining access to care and should serve as a reminder that it may not be sufficient to provide a referral for care in the absence of guidance and support through the process," they said.

This research was supported by the National Institute on Minority Health and Health Disparities.

“Funny” Is No Laughing Matter

By Donna Gibson

Published Dec 19, 2013

“I don’t feel right!” Don said.  My husband, who has type 2 diabetes, had just walked back in our front door, after having gone into town to do some Christmas shopping. Or so he said. He only came back with gifts from one store. He felt “funny,” he said, afraid to drive. Which was odd, since I’d only fed him a few slices of whole grain toast with butter and a glass of milk before he left, nothing that would bring on the “funny feelings” about which diabetics often complain.

“Funny” in our home is no laughing matter. It’s how my husband feels when he’s not being active or when he’s eaten something he shouldn’t have eaten. I suspected foul play–a soda, maybe some greasy fries, eaten in secret, as diabetics often do–and called him on it. “Quit preaching to me,” he said.

As a caregiver, I prepare the majority of our healthy meals from home, but that doesn’t mean Don doesn’t sneak in something greasy and juicy when I’m not looking. The “funny feelings” he describes occur when his glucose is off balance. The hard part for me is trying to walk those fine lines between caregiver and scold, wife and caregiver, friend and foe. He’s nearly sixty years old, and we’re still figuring out this dance.

The other night, while I was preparing dinner, Don was working on his train platforms that we put up each year during the Christmas season. But then suddenly he was sitting in front of the TV, feeling “funny” again. I’d suggested a healthy snack, but I suspect he grabbed a Mountain Dew and a piece of dark chocolate from his secret stash in his car. He was so out of it, I grabbed the camera and took a photo. Maybe if he sees himself during these unfunny “funny” moments, particularly now, during the sugar-laden Christmas season, he’ll think twice about indulging in sugar.

At least I hope so. I don’t like being the scold. I suspect Don doesn’t love it either. He’s only had diabetes for a year. He’s probably still in the denial stage of the illness. It’s hard on him, but it’s hard on me, too, and I’m not sure what the solution is other than to keep reminding him of all the things that can go wrong if he doesn’t heed his body’s warnings. I’d like to keep him around. And I hope 2014 will bring a bit more discipline, a bit less “funny,” a bit more fun: the real kind.

Merry Christmas, everyone.

FDA to Examine Surgical Mesh Device for Female Fecal Incontinence

Previous scandals, concerns about adverse events surround TOPAS System

 by Molly Walker
Contributing Writer                                   

The safety, efficacy, and relative benefits of the investigational TOPAS System, a medical device using implantable surgical mesh to treat female fecal incontinence after more conservative treatments have failed, will be the subject of an FDA advisory panel meeting on Thursday.
Because no medical device currently exists to treat this problem, ASTORA Women's Health (which produces the TOPAS System) was required to submit a premarket approval application, including a clinical trial to test the device's efficacy and safety. The trial achieved its primary endpoint, but, as FDA staff noted in briefing documents released ahead of the meeting, questions still remain about its safety.
The TRANSFORM trial needed to achieve a ≥50% reduction in the rate of female fecal incontinence episodes over a 12-month period compared to baseline, as documented by a 14-day diary. Overall, 52 of 80 participants completing the efficacy trial achieved this primary endpoint (65%, P=0.0048) at some point during 3 years of follow-up. The device also achieved several secondary endpoints, such as long-term effectiveness, a reduction in incontinent days, fecal incontinence episodes, and symptom severity.
However, 72 of the 152 patients in all who received the implant reported adverse events related to the device (47%). Of these, the most common was pain (45%) followed by infection (27%), and 12% reported new or worsening pelvic organ prolapse.
Implantable surgical mesh in the pelvic region is certainly no stranger to controversy, with the FDA recently classifying transvaginal mesh for pelvic organ prolapse as a class III medical device. Manufacturers of this device -- versions of which have been the subject of numerous lawsuits -- are now required to undergo a rigorous premarket approval application to address concerns about adverse events. At issue for the FDA will be the safety profile of the TOPAS System, including concerns about the causes of the pain and the association of pelvic organ prolapse with this procedure.
The clinical trial for the TOPAS System required patients to be 18 years of age or older, not be pregnant or planning to become pregnant and to have tried other more conservative therapies to treat fecal incontinence, such as dietary modifications, pharmacologic therapies, or pelvic floor muscle training. The advisory committee will be asked whether the product should be labeled with these restrictions.
As there was a trend toward fewer adverse events when the device was implanted by a urogynecologist as opposed to a colorectal surgeon, FDA officials will also ask panelists for their opinions on the clinical training or experience required for clinicians to implant this device.

The agency also has concerns about the potential performance goals being proposed for two planned post-approval studies of the TOPAS System. ASTORA has a stated 25% performance goal for an extended follow-up of the existing cohort for a period of to 60 months and a 20% performance goal for a new cohort of patients followed for a period up to 36 months.
"These performance goals are based on the performance of a different device that does not modify the anatomical structure of the pelvic muscles," agency staff wrote. "The FDA recommends the applicant take into consideration the nature of the implanted device, the risk/benefit ratio, and the results from the TOPAS premarket study when developing the performance goal for the post-approval study."
Panel members will not be asked to vote explicitly on whether the device should be approved, but the three voting questions on the agenda are whether they believe the product is safe, whether it's effective, and whether the benefits outweigh the risks.
The FDA is not required to follow advisory committee recommendations but it usually does.

                                                                   

FDA Panel Backs Implant for Female Fecal Incontinence

Unanimous support for novel mesh device

           

 

by Shannon Firth
Contributing Writer                                   

BETHESDA, Md. -- An FDA advisory committee unanimously agreed at a Thursday meeting that the benefits of an implantable surgical mesh device for women with fecal incontinence outweigh the risks.
The so-called TOPAS device, developed by ASTORA Women's Health (a subsidiary of Endo International), is intended for women who have failed more conservative treatment options, such as diet changes, pharmacologic therapies, or pelvic floor muscle training. It is a "non-bioabsorbable mesh device" approximately 45 cm in length that's inserted parallel to the puborectalis muscle below the anorectum, according to FDA briefing documents.

Members of the FDA's Gastroenterology and Urology Devices advisory committee voted 8-0 that the TOPAS treatment for fecal incontinence provides "a reasonable assurance of safety" and of effectiveness, and that the risks -- which are not insubstantial -- are tolerable given the relief seen in clinical trials.
The panel recommended postmarket studies, adequate training of surgeons, and labeling to indicate use in women 18 years or older who are not pregnant. (Some panelists suggested an additional warning for those who may become pregnant.)
While the mechanism of action is still unclear, the TOPAS system is thought to help support the puborectalis muscle, which appears to weaken in people with fecal incontinence. This weakening causes a change in the anorectal angle, which allows stool to move down the rectum involuntarily, a member of FDA's technical staff explained.
Agency briefing documents further clarified the theory that "the fixation of the mesh implant provides the physical support of the anatomy." In time, tissue growth around the device occurs, as the body heals, further enhancing this support.
In the product's main clinical trial, 52 of 80 participants completing the efficacy trial showed at least a 50% reduction in fecal incontinence episodes over a 12-month period, the study's primary endpoint (65%, P=0.0048). The device also met several secondary endpoints, such as long-term effectiveness, a reduction in incontinent days, fecal incontinence episodes, and symptom severity.

However, 72 of the 152 patients in all who received the implant reported adverse events related to the device (47%). Of these, the most common was pain (45%) followed by infection (27%), and 12% reported new or worsening pelvic organ prolapse.
At the heart of the committee's decision were a few unknowns: how much pain is a woman willing to tolerate to improve her continence? Is pelvic organ prolapse worth the risk of gaining back continence?
Susan Kalota, MD, a urologist in Tucson, Ariz., said most women would agree to risk some pain in exchange for continence. "So it's just, how many are in the debilitating, God-awful pain?" she asked.
As for the second question, Kalota added, "The vast majority of women would easily trade prolapse for continence."
The committee's patient representative agreed. "Wetting your pants is not nearly as difficult as defecating in your pants," said Barbara Berney, from Rockford, Ill.

On the other hand, Jonathan Efron, PhD, a professor of urology and surgery at Johns Hopkins University in Baltimore, reminded the panel that a patient might have pain or prolapse without benefit from the surgery. Those patients "probably wouldn't be happy." Nevertheless, he agreed with other panel members that the benefits outweighed the risks overall.
In its presentations, the sponsor sought to distinguish the TOPAS system from transvaginal mesh devices, which have been associated with severe pelvic pain and organ perforation. The transvaginal mesh devices were also entrenched in countless lawsuits and a complex scam involving unscrupulous health plans who profited from their removal.
Unlike the transvaginal mesh devices which are inserted on top of the vagina, the TOPAS system is placed two centimeters from the anal rectum with a cushion of fat in between, the sponsor explained. The sponsor emphasized that to date none of its devices have required revisions or removal.
Asked if the device was possible to remove, the sponsor's representative said the device is intended to be permanent. But one of the firm's consultants later stated that it would be possible to explant the device, and that an ultrasound could be used to help locate the mesh.
Several panelists seemed skeptical about the possibility of complete removal because of in-growth around the device.

There also appeared to be a disparity in adverse events depending on who performed the surgery -- colorectal surgeons versus urogynecologists -- which favored the latter. But other factors, such as stretching regimens followed by participants prior to the surgery at some centers and not others, may have accounted for such differences.
Jason Connor, PhD, a statistician based in Orlando, Fla., recommended conducting more research on the effect of stretching on adverse events.
The committee spent some time discussing the lack of a control group in the pivotal study. At the time it was conducted, no other therapies or treatments were available to serve as a comparator and using a sham device as a comparator was considered "unreasonable," because it would require a control group to undergo anesthesia and receive incisions.
The committee did not reach consensus on whether studying new comparators was important. One panelist recommended a well-matched prospective cohort to gauge the rate of certain adverse events such as prolapse, without a procedure.
Cheryl Iglesia, MD, a urogynecologist based in Washington, D.C., recommended that a registry be used to conduct postmarket surveillance on surgical outcomes and to determine which surgeons may need additional training. She also suggested the possibility of using imaging to distinguish characteristics of responders and nonresponders.

The sponsor submitted its request for premarket approval in April 2014, received a deficiency letter in July 2014, and then submitted additional information to the FDA in July and October 2015.
The FDA could not say when a final approval decision would be made. It is not required to follow the advice of its advisory committees but it often does.

Less Sleep, More Weight?

Posted on May 4, 2015, 6 a.m. in Weight and Obesity Diabetes Sleep

Losing as little as 30 minutes of sleep per day on weekdays may be particularly problematic for type-2 diabetics.

Waking up tired - image from Shutterstock

Waking up tired - image from Shutterstock

Previous studies have report that short sleep duration associates with obesity and diabetes.  Shahrad Taheri, from Weill Cornell Medical College (Qatar), and colleagues assessed 522 men and women with newly diagnosed type 2 diabetes mellitus (enrolled in the Early Activity in Diabetes trial), randomly dividing them into one of three groups: usual care, physical activity intervention, or diet and physical activity intervention. Participants completed 7-day sleep diaries and calculated their weekday sleep debt. At the study’s start, the researchers recorded their height and weight to determine obesity status, measured their waist circumference for central adiposity, and analyzed their fasting blood samples for insulin sensitivity.  At baseline, compared with participants who had no weekday sleep debt, those who had weekday sleep debt were 72% more likely to be obese, and by the 6-month mark, weekday sleep debt was significantly associated with obesity and insulin resistance. At 12 months, for every 30 minutes of weekday sleep debt at baseline, the risk of obesity was raised by 17% and insulin resistance rose by 39%.  The study authors warn that: “The long-term effects of weekday sleep debt may cause metabolic disruption, which may exacerbate the progression of type 2 diabetes mellitus.”`

How to prevent diabetes

Information on how to prevent diabetes
from A4M Longevity Magazine eJournal . . .

More Fish May Lower Diabetes Risk

Salmon, herring, and sardines are among good sources of omega-3 fatty acids that may help to reduce the risk of Type-2 diabetes.

Type-2 diabetes is becoming increasingly widespread throughout the world. In that previous studies posit that overweight is a significant risk factor, diet and other lifestyle factors may have potential as interventive approaches to reduce a person’s risk of Type-2 diabetes. Jyrki K. Virtanen, from the University of Eastern Finland (Finland), and colleagues analyzed data collected in the Kuopio Ischaemic Heart Disease Risk Factor Study (KIHD), determining the serum omega-3     

      fatty acid concentrations of 2,212 men, ages 42 to 60 years age at the onset of the study, in 1984–1989. During a follow-up of 19.3 years, 422 men were diagnosed with type 2 diabetes. The team found that men in the highest serum omega-3 fatty acid concentration quarter were at 33% lower risk of developing type 2 diabetes, as compared to those men in the lowest quarter. The study authors report that: “Serum long-chain omega-3 [fatty acid] concentration, an objective biomarker for fish intake, was associated with long-term lower risk of type 2 diabetes.”