2012 Update Medical Device Patient Safety Act proposed

Medical Device Patient Safety Act-Call to Action!

Waddling Gait from Greater Tronchanter Avulsion fracture

I am seeking people who have had implants as a voice to Congress!  Are you interested in supporting a non-profit or being a voice for the Medical Device Patient Safety Act?

As a Texas resident and effected American I am calling on your support for the Proposed Bill called the Medical Device Patient Safety Act, Sponsored by Senator Richard Blumenthal (D-Conn.) and Co-sponsored by U.S. Sens. Chuck Grassley (R-IO) and Herb Kohl (D-WI) would mandate that the Food and Drug Administration (FDA) track recalled medical devices and better manage recalls when problems occur.

Faulty medical devices such as metal-on-metal hip implants require “Strong action to stop defective medical devices”. Consumer must have safeguards implementing protocol for doctors, hospitals and other medical professionals involved. The bill should protect Americans requiring notification to Americans from the FDA and manufacturer about faulty products and recalls more quickly. In the Bill I would like to see Kickbacks from Manufacturers to Doctors and Hospitals be Illegal and Human testing for medical devices required prior to release for implantation in Americans.

I Suzy Britz age 43, married 25 years, mother of 4 and real estate agent in Flower Mound Texas, would like to express how urgent and critical this proposed legislation is to get passed for Medical Device Patient Safety. After talking at length with my doctor it was my understanding that the metal on metal devices were described to be best for active people. At age 41 on 2/2/2010 I had bi-lateral hip metal-on-metal devices installed. Since the surgery I have experienced infections, muscle pain throughout my body, inflammation, the inability to walk more than half mile distance and a host of other ailments. I have visited multiple doctors and underwent batteries of tests.

Awareness must be made to patients who have the metal-on-metal hips or other implanted devices. Prior to having the hip replacements I did not experience muscle pain and other aliments I face today. It was my understanding that the hip replacments would allow me to lead a more active lifestyle giving more mobility. The current hip implants I have are the S-Rom total hip metal on metal which have not been recalled however I suffer daily with a severe waddling gait and chronic pain.

 

 

Left Fracture on doctors X-ray dated 3/15/2010 on my post op visit for Hip Replacements showed greater trochanter avulsion fracture HOWEVER the fracture was not DISCLOSED- TOLD to myself or husband until 11 months later.

Going through Bi-lateral hip implants has left me crippled and in daily pain!

I walked around 11 months without knowing that I had a fractured left greater trochanter avulsion fracture. I pushed through over 6 months of Physical therapy and went to numerous doctors trying to discover WHY? My left pelvis was dropping when I walked. I have terrible lower back pain L5-S1 pain and moderate neuropathy on my left leg confirmed by neurologists!

The left Tip of Femur cracked off taking the hip abductor muscles and or group of muscles attached to the tip of the femur causing the waddling gait pattern when I walk. I have been to numerous orthopedic surgeons for opinions and have emailed doctors in other countries only to be told they do not have a procedure to perform so I can walk without my pelvis falling. Any surgery in the future to try and correct this would be experimental!

Why did the surgeon who performed the Bi-Lateral hip replacement not identify the greater trochanter avulsion fracture on my 6 week post op visit after the bi-lateral hip implants? Why did the orthopedic and or trauma surgeon who saw me in the ER 8 weeks post op when I broke my left Right femur not identify the Left avulsion fracture?

The orthopedic surgeon who performed the femur fracture surgery on the right leg never identified the left avulsion fracture. So I was sent home putting my weight walking on crutches on my left avulsion fracture. Why did the x-ray or CT scan radiologist not add the Left avulsion fracture to the report when he x-rayed both legs? The doctors and hospital had been told and it is documented in patient records I was only 8 weeks post op from Bi-lateral hip implants.

Why when I went back to my original orthopedic hip surgeon for follow up a few weeks after the Right femur fracture surgery did the orthopedic surgeon not see the fracture on the left side? Time after Time Doctors and Radiologists missed the greater trochanter avulsion fracture!

A Pain Management doctor I sought out IDENTIFIED 11 months after Bi-lateral hip implants an old displaced avulsion fracture during a pain injection on the TV screen as he was guiding the needle in.

Wow! Oversight after Oversight and I am paying for it with daily waddling and pain! So when I fell at IHOP and was on crutches putting my weight on my left leg. I was walking on an avulsion fracture that had occurred within the past 6 weeks.

I am now 2 years post op from the 2nd femur operation on my right side and my left femur that I did not fall on is still fractured since the doctors have no way of repairing the fracture due to the fracture not being identified.

Is this fracture on the left side from improper medical device installation? Is the fracture on the left side from weakness in the bone due to the metal hip implant? No medical professional can tell me! Best news is that the S-Rom metal on metal hips inside me were NEVER been tested on humans prior to being approved for use in the USA!