Government Accountability Office to Review Power Morcellators

powermorcellatorThe US Government Accountability Office announced yesterday it would be investigating the use of laparoscopic power morcellators, at the request of 12 members of congress, who cited the deaths of “hundreds, if not thousands of women in America” who have died from uterine cancer or other gynecological cancer.

Back in November of 2014, the FDA issued a black box warning to ensure physicians and their patients know about the risks of power morcellators. If you are unfamiliar, power morcellation is used in a non-invasive hysterectomy or myomectomy surgeries.  In a laparoscopic hysterectomy surgery, the uterus is minced up, (morcellated), into smaller pieces inside the woman’s belly cavity in order to be extracted from the abdomen. It can consist of a hollow cylinder that penetrates the abdominal wall, ending with sharp edges or cutting jaws, through which a grasper can be inserted to pull the mass into the cylinder to cut out an extractable piece.

But was the less invasive surgery really worth the risk? The advantage of using a morcellator device is of course, a smaller incision and quicker recovery. However, if the woman has undetected cancer such as uterine sarcoma, the breaking up of tissue can increase the risk of cancerous tissue being spread throughout the woman’s abdomen and pelvis. And this has happened a lot. Read much more on fredhutch.org. There have been dozens of reported incidents, and so far about 45 lawsuits have been filed in federal or state court.  The US Judicial Panel on Multidistrict Litigation has consolidated more than 20 lawsuits into an MDL (number 2652) which was approved in October.  Fortunately, the use of morcellators has largely been abandoned.

The companies being sued in power morcellation lawsuits include Johnson & Johnson, which makes the Ethicon Gynecare Morcellex Tissue Morcellator.

Ava Meets Olaf (the inflatable version)


Ava was gone for a few days in Oklahoma for the Thanksgiving holiday, and I missed her so much!! I had some time to do a little Christmas decorating, and while I was at Lowes shopping around, I saw an inflatable “Olaf” snowman from Frozen, our favorite movie. I knew she would just love it him, so I brought him home. When Ava got out of the car, she spotted the deflated snowman and immediately had to investigate. I went and plugged in his little fan, and whipped out my phone to capture the magic. She was so excited!

Xarelto Bleeding Lawsuit MDL Growing, More Lawsuits Filed

xarletoWe’ve been watching Xarelto lawsuits work their way through the legal system since the FDA first issued that warning letter to Johnson & Johnson back in June 2013. It was predicted that lawsuits would continue to be filed, and that’s just what’s happened. One of the legal blogs I follow, Lawyers and Settlements, reported this week that the MDL has more than 2,200 consolidated cases. That’s a lot more than 11 months ago, when about two dozen lawsuits were first consolidated back in December 2014.

Xarelto, generically known as rivaroxaban, was first approved by the FDA as an anticoagulant or “blood thinner” back in July 2011. In November 2011, the FDA approved it to reduce stroke risk in people with atrial fibrillation. In November 2012, the FDA approved Xarelto for deep vein thrombosis.

Xarelto is different than Coumadin / warfarin, the blood thinner that’s been on the market for decades. Unlike  Coumadin, patients taking Xarelto do not need to undergo routine blood tests. However, there is no antidote for Xarelto. With Coumadin, if a bleeding event occurs, a patient can be treated with Vitamin K, and usually the bleeding can be stopped. In a patient treated with Xarelto, a bleeding event is potentially life-threatening.  Bayer, the manufacturer of Xarelto, is working on an antidote. The first Xarelto-related death was reported to the FDA in November 2011.

The thousands of lawsuits that have been filed allege that patients were not warned that there was no antidote to Xarelto, One of the more recent lawsuitd was filed by Ashlie Fluitt, whose grandmother, Hattie Deville Goodwin, was prescribed Xarelto in September 2014 for her deep vein thrombosis. Two months after she began taking Xarelto, Deville-Goodwin experienced an intracranial bleed, which was irreversible and fatal. She passed away on November 14, 2014.

The first bellwether Xarelto cases will likely go to trial early in 2017. From the thousands of cases now in the MDL – and those projected to have come forward by the start of the New Year – 40 cases will be shortlisted. Plaintiffs and defendants will choose 10 cases each, with another 20 cases chosen at random. If you’ve experienced a bleeding event while taking this drug, you should contact a Xarelto lawyer – as soon as possible.

 

Flying Adventures From Oceanside to Carlsbad, Chino, and Back

Yesterday, I did a quick little cross country flight up to Chino, a county-owned “reliever airport” right next to the big Ontario Airport up there in San Bernardino County. As part of my cross-country training, I need 50 hours of cross-country flying time. For the FAA’s purposes and logging,  a cross country flight includes “a point of landing that was at least a straight-line distance of more than 50 nautical miles from the original point of departure.” From my home airport, Chino is a straight line of 48 nautical miles. But, if I fly from Oceanside to Carlsbad Airport (KCRQ), and take off there, it is a 54 NM straight line. So I flew from Oceanside to Carlsbad, picked up Andy and a friend, and we flew that hop up to Chino and back to Carlsbad. Then, I popped in the cockpit GoPro and flew home. Here’s footage of that short six mile flight from Carlsbad to Oceanside.

Checking the Sensitivity of the VOR Receiver (for the IFR Written Test)

CDILet’s talk about radio navigation, VOR’s, and OBS’s.  Three of my favorite things! There are quite a few questions on the IFR written about VORs. And there is one particular  question on the IFR written test about checking the sensitivity of a VOR receiver, and how many degrees in course change there should be as the OBS s rotated, all the way, right or left. This is not the same as checking the accuracy of a VOR (you need to check the accuracy this every 30 days if you’re flying IFR). You turn the knob to move the course deviation indicator (CDI) from the center all the way over to the last dot on either side. The selected course should not exceed 10 degrees or 12 degrees on either side. Each dot on the CDI represents 2 degrees.

 

YouTube Playlist Specifically for Studying for the IFR Written Test

I’ve been busy studying for the IFR written test, which I plan to take in the next month. When I took the Private Pilot written test, I found it helpful to listen to test questions while driving around in my car. There were some good apps for this, but I nothing on Youtube. For the IFR written, I’ve decided to make my own study guide, and publish it on YouTube. I’ve been putting questions together on a YouTube playlist. I cover everything from hazardous weather to aircraft icing, airport signs to gyroscopes. I’m trying to add videos daily. Some of the questions are “easy” and some are harder. I do some questions that are challenging to me, and some questions that I think might help others. Check it out!

Taylor Swift Quote – “There are two ways you can go with pain”

taylor-swift-there-are-two-ways-pain I am a longtime Taylor Swift fan. I admire her confidence, talent and wisdom. This quote about pain is one of my favorite quotes from her. I am not sure when she said it, but it is widely attributed to her. It is a reminder to all of us that when bad things happen, there is always a choice.

Save it For A Rainy Day – Kenny Chesney Lyric Video

I have been loving Kenny Chesney’s single “Save it for a Rainy Day” these last couple weeks. When we did an IFR to VFR on top flight on Saturday, along with some cloudsurfing, it seemed like the perfect song to make a lyric video to. This was just for fun, but I think it came out pretty good. We had some baby rain on takeoff and then went through the clouds, and it wasn’t rainy anymore.  On the way back in my CFI Andy showed me how to do an instrument approach on autopilot – just amazing to see and great stuff to learn for instrument training!!  Plane is N9897F, Pinnacle Aviation Academy

 

 

First Cross Country Flight Video – Carlsbad to Lancaster


For those interested, here is video from part of yesterday’s cross country flight,  – my first ever – from the takeoff at Carlsbad’s Palomar Airport (KCRQ) out to Bonsall and then the landing at Fox Field (KWJF) – and spotting two landmarks, “the prison” and “the racetrack”. I learn something every time I fly. Yesterday, I filed my flight plan under the wrong tail number. It wasn’t that big of a deal, but I know I will never do that again!  Thanks to my awesome instructor Andy for letting me bring the GoPro up and being patient with all my questions.

Understanding Pressure Altitude and Density Altitude


At my next stage check, I know I’m going to have to explain pressure altitude and density altitude. And when I become a CFI I’m going to have to teach other people what they are, so I need to learn it. And understand it. And most importantly, be able to explain it. Thank goodness for Youtube videos, I can get some free education that will supplement everything I’m paying to learn at Pinnacle.

Pressure altitude is simple – it’s what you get when you dial 29.92 in your altimeter.

Density altitude is pressure altitude corrected for temperature and humidity. Or, pressure altitude corrected for nonstandard temperature. Another way of thinking about density altitude is this: Density altitude is the altitude the airplane feels like it’s at.

At some point my examiner is going to ask me to calculate density altitude. I know there are two pieces of information I need to figure this out. Pressure altitude and temperature. I can get the temperature right off the thermometer. I can find the pressure altitude by setting the altimeter to 29.92 and reading the altitude off the altimeter. Another method of calculating pressure altitude: take standard pressure, subtract the current pressure, multiply it by 1,000 and add the field elevation.

If you don’t have a flight computer, or an E6B, you can find density altitude using this formula:

Density Altitude = PA + (120 x (OAT – ISA Temp)

PA = 120 x (Outside Air Temperature – Standard Temperature (always 15))

In the wintertime, when it’s cool, and especially near sea level, density altitude isn’t really a big deal. In the summer time, when it heats up and air is humid, density altitude can be a big deal. Not so much here in Carlsbad, but in other areas, particularly high elevation areas where it gets hot, density altitude is very important. Remember, a high density altitude is NOT a good thing.

A surprisingly accurate rule of thumb (usually any error will be less than 200-300 feet) for determining the density altitude is easy to remember. For each 10-degrees Fahrenheit above standard temperature at any particular elevation, add 600 feet to the field elevation. (And, conversely for each 10-degrees F below standard temperature, subtract 600 feet from the field elevation.)

Example: It is 79 degrees Fahrenheit at Carlsbad, so that’s 20 degrees about standard temperature (standard temperature is 15C/59F) Add 1200 feet (600×2) to the field elevation of 330. Density altitude calculated by the rule of thumb method would be 1550. Using the 29.92 barometric pressure calculated on a flight computer, density altitude would be 1,673. So, pretty close.