The Public Citizen has sent the FDA four letters this week about regulation and approval of medical devices. The first letter is about the FDA’s approval of a Anti-Scarring Device for children. The SyntheMed’s REPEL-CV device is designed to reduce post-surgical scarring in children following open-heart surgery. Public Citizen found some major problems.
In the trial, there were also signs of possible dangers associated with REPEL-CV, including trends toward higher risks of death and chest infection. These differences were not statistically significant, but the consistent direction of the adverse effects observed, even if non-significant, is concerning. Because the trial was so small, we can only be assured that there was not more than a three-fold increase in mortality and not more than a 10-fold increase in chest infections for patients implanted with the device. This is hardly reassuring.
The approval of REPEL-CV bears an eerie resemblance to another device, Intergel, an anti-scarring device intended for pelvic surgeries that also demonstrated reduced scarring without clinically validated outcomes. That trial was also underpowered for safety and showed a consistent but non-statistically significant increase in infection rates. Less than two years after Intergel was approved, the company removed the product from the market due to reports of post-operative pain, foreign body reactions and tissue scarring requiring repeat surgery, including three deaths among women who received it. This history should have given the FDA pause before once again approving a similar device with a questionable safety record.
The second letter dated March 10th, concerned the FDA’s negligence in delaying their response to problems with a pediatric breathing device. The FDA on Monday, finally announced a Class I recall of the Shiley 3.0 PED tracheostomy tube.
The FDA’s lack of response is obscene.
This highlights the painfully slow and lethargic way that the agency responds to emerging problems with medical devices. This delayed and therefore negligent FDA announcement comes three months after the agency was first aware of problems with the device and two months after the company had warned its customers and begun a recall.
Class I recalls are reserved for cases in which the device may cause serious health problems or death. The recall of roughly 5,000 Shiley tracheostomy tubes is due to a modification that led to difficulty inserting the tube into the neck and difficulty inserting a secretion suction device into the tube. Nellcor sent an urgent alert to customers Jan. 14 warning of the problem and initiated a recall.
The Public Citizen hammered the FDA with a third letter on March 12th, condemning the Commissioner regarding the delayed recall of defective Intravenous Infusion Pumps. The manufacturer has admitted the use of their infusion pumps “may lead to serious injury and/or death.”
The first Class I recall of these devices was on July 19, 2005, and was due to pumps shutting down without warning.[3] At this time, the company acknowledged six serious injuries and three deaths were associated with the device. Since then, there have been six additional recalls including the one announced yesterday. The recalls and the reasons for the recall are listed in table below.
Amazingly, because of problems such as battery failures, false alarms and alarm failures, and inadequate infusion, Baxter has not sold the pumps in the U.S. since 2005, according to The Chicago Tribune.[4] But pumps continue to be used for patients in this country.
The fourth and final letter was sent by Dr. Wolfe, Director for The Public Citizen asking the FDA why they hadn’t announced the recall of a Welch Allyn automatic external defibrillator (AED), a life-saving device typically used by emergency personnel to resuscitate patients in cardiac arrest.
Malfunctions related to this recall have been linked to two deaths.
On Feb. 26, Welch Allyn initiated a Class 1 recall of 14,000 of its AEDs. As of this morning, the FDA has not tried to alert the American public.
Incredibly, this is the eighth – and most serious – recall of a Welch Allyn AED since 2004.
The FDA’s miserable failures have been well documented. My question: how many people have to die or get seriously injured for life before the FDA gets a complete personnel overhaul?
TheZoo 
freb,
All of this is a gift from the G W Bush admin. It seems this misery will be undone by this September or October. Egads, W, had seven years to clean up his litter box!
Good Morning Walt 🙂
I agree, it is a gift that keeps giving unfortunately. Andrew von Eschenbach left a hell of a mess for Frank Torti to clean up in the meantime.
What doesn’t look good is the fact Torti has been with the agency since last year as Chief Scientist and is aware of the problems. His secondary title as Principal Deputy Commissioner put him second in command under the Commissioner.