What happened to the the FDA‘s request, NOTHING HAPPENED.
The FDA gets heat put on them especially in todays enviornment and all of a sudden the words FDA appears as they propose 100 different plans to improve their past performance. The reality they are just BULLSHI-ting the very people that pay their salaries and the same people they are suppose to protect.
They have requested post market studies from Smith & Nephew upon the pma approval of their birmingham hip in 2006. When I found the information Smith & Nephew provided I asked myself how in God‘s name doesthis help anyone. The information told me the test group used was 18-21 years of age and that was about it. Young folks with hip resurfacing devices, hmmm not being a doctor I would think an 18-21 year old would heal quickly and probably have no adverse events.
Their first marketing suggests all ages and genders, then that marketing changes as the adversities do start showing up.
I have a letter in my attorney’s possession from Smith & Nephew addressed to a local surgeon I know, addressing the issue of benign, inflammatory ” pseudo-tumors” in metal on metal hip resurfacing. The letter mentions their current investigations and recommendations related to this recent subject in the literature and scientific meetings.
One of the FDA pma approval stipulations was Smith & Nephew was to conduct investigations on the effects metal particles could have on the human body. Where are these investigations ??? If Smith and Nephew does provide any information at all they use the same controlled patient group of the inventor.
Again no USA patients used in a controlled study other than ME and YOU that are now suffering from implanting this device in my ( our) bodies. Had there been proper protocol after the post approval of the birmingham hip perhaps I (others) would not be in a wheelchair today as a result of using the bhr.
The FDA can’t controll it’s existing policies, who could, there are so many organizations, sub-sections, rules it ultimately impossible to try to get an HONEST answer, and if I do what is the FDA prepared to do about it, sit on their A-S as they have been doing regarding metal hips.
Hire me I will be the ” Elliot Ness ” and I will clean the corruption up. Give me a court that will put up with no bullsh-t, when documents are requested by the defendant or plaintiff they will be provided without all the red tape, give me a direct line with the President or person He directs, so there are 100 different people involved trying to decide which organization shouls look at this matter.
I will make more tax dollars for my country by eliminating this cancer. By taking this type of affirmative action people may regain confidence in the medical device world and people may regain confidence in the very Government that is suppose to protect and ensure the quality of our lives.
Yes, their maybe a big shake up and the medical device manufacturers may threaten to take their operations abroad, but stop and think for a second how many of these medical components are actually made in the USA to begin with ???
They may threaten tolay off thousands of workers, they are all ready. Some excuses currently may blame the user tax fee.
All B-S these manufacturers are making billions of dollars each year.
It makes me ill reading about the number of hip devices being taken off the market by the manufacturers and the FDA still sits on their A-s. Then to put the icing on the cake the manufacturers are setteling up with victims by offering chump change for their sufferings.
It reminds me of paying a traffic fine and promising to be good. The system hasen’t improved by payment of these token funds to victims it is very close parallel to the kickbacks these same manufactures have been repeat offenders of.
They get caught-pay a fine and repeat the offense again.
So how is the FDA protecting you or me, they maybe with some devices but that doesn’t give them a free pass to allow devices to be implanted in our USA bodies that have not been properly tested and certainly not in the case with Smith & Nephew and its sole patient group contolled by one of the inventors who also received 99 million pounds for the device—that is a conflict of interest isn’t it.
- Howard Says – And We Agree – Come Clean Smith & Nephew (earlsview.com)
- In Wake of Smith & Nephew Hip Recall, Company Reports Third-Quarter Sales Drop, as Hip Replacement Sales Slide 4% (earlsview.com)
- Growing metal-on-metal hip controversy threatens to swallow more device makers | MassDevice – Medical Device Industry News (earlsview.com)
- Smith and Nephew Issues Failure Warning on Metal Hip Implant – Florida Mass Tort Attorneys, Lawyers | Searcy Mass Torts (earlsview.com)
- In Wake of Smith & Nephew Hip Recall, Company Reports Third-Quarter Sales Drop, as Hip Replacement Sales Slide 4% (prweb.com)
- Smith & Nephew Ethics… (earlsview.com)
- GOT-CHA – Hips: Smith & Nephew issues failure warning on Birmingham metal-on-metal hips | MassDevice – Medical Device Industry News (earlsview.com)
- Q: Who is going to pay the Mortgage Mr Smith & Nephew while two BHR’s are revised? (earlsview.com)
- Hip Resurfacing Draws Warning After Study Published in Lancet – NYTimes.com (earlsview.com)
- NZ – Metal on Metal – Smith & Nephew – Medsafe hip device statement | Scoop News (earlsview.com)