If You Thought the Food and Drug Administration Competently Regulates the Safety of Implanted Medical Devices, You Guessed Wrong Enough to Get Yourself Killed

10 August 2010

Lack of competently-pursued FDA oversight kills people

The Food and Drug Administration supposedly regulates medical devices ─ but its judgment and regulations are so flawed that some really dangerous devices make it into people’s bodies, without a peep from the agency.

While reading this, ask yourself a question

Why is this deadly lack of regulation allowed to continue?

My pertinent background

While a state assistant attorney general, part of my responsibility was to advise the Attorney General regarding multi-state litigation involving pharmaceutical companies and medical device manufacturers.

The amount of unlawful abuses and over-the-top negligence taking place in both sectors of the medical economy was surprising ─ even to someone with my ex-cop’s/ex-medical student’s tendency to be realistically cynical about human motivations.

What follows is another example of the virtually complete failure of our regulatory agencies to reign in the voracious greed that motivates making money at the direct expense of other people’s lives.

What does the Food and Drug Administration do regarding medical devices?

Rita Redberg, an editor for the Archives of Internal Medicine, this week examined the FDA’s miserable performance in regulating medical devices. She noted that the agency classifies devices according the degree of harm they can potentially cause.

Class I and II devices need only to pass a simple premarket notification screening. Class III devices require submission of premarket approval (PMA) clinical data that prove safety and effectiveness.

So far, so good.

But the FDA does not really do what it is supposed to do

The FDA does not actually do much, if any, of what it is supposed to do in regard to regulating medical devices:

A 2009 Government Accountability Office study discovered that the FDA did not deny approval of a single PMA submission between 2003 and 2007.

Moreover, even though the FDA claims that “most Class III devices require Premarket Approval,” nearly 60% of the Class III devices approved during this period failed to undergo the PMA process at all and instead received 510(k) clearances which do not require clinical data.

These statistics alone strongly suggest that the FDA’s device approval process needs urgent improvements.

© 2010 Rita F. Redberg, Medical devices and the FDA approval process: balancing safety and innovation; comment on "prevalence of fracture and fragment embolization of bard retrievable vena cava filters and clinical implications including cardiac perforation and tamponade", Archives of Internal Medicine 170(20):1831-3, DOI: 10.1001/archinternmed (08 November 2010)

Citation to the Government Accountability Office report

United States Government Accountability Office, The FDA Should Take Steps to Ensure that High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process (15 January 2009) http://www.gao.gov/products/GAO-09-190 (visited 10 August 2010)

Notice that the GAO doesn’t mince words in its title: “most stringent premarket review” (underline added).

A deadly example of why this matters

Vena cava filters are medical devices.

Inferior vena cava filters are implanted in patients endovascularly using catheters, rather than via direct surgical access. Placement of the filter in the vena cava vein is intended to prevent thrombi (blood clots) from moving into vital organs, particularly the lungs (where clots are called pulmonary emboli). The formation and/or migration of thrombi can be fatal.

If the implanted filter breaks, it can cause or add to the problem it was supposed to prevent.

Breaking Bard® vena cava filters reported by the Archives of Internal Medicine this week

William Nicholson et al. examined the incidence of broken Bard® (a brand) retrievable inferior vena cava filters in 80 patents.

The researchers found that (a) 25 percent of the older Bard (“Recovery”) filters had fractured (broken) and (b) 12 percent of Bard’s newer ones (“G2”) had, too. One of the 80 people died.

The lower rate of fracture for the newer variety of Bard filters was presumed to have been due to having been in the human body for less time.

Nicholson group’s findings

The Nicholson group’s findings were shocking:

Thirteen of 80 patients had at least 1 strut fracture (16%). At least 1 strut in 7 of the 28 Bard Recovery filters fractured and embolized (25%).

In 5 of these 7 cases, patients had at least 1 fragment embolize to the heart (71%).

Three patients experienced life-threating symptoms of ventricular tachycardia and/or tamponade, including one patient who experienced sudden death at home.

Six of 52 Bard G2 filters fractured (12%). In 2 of these 6 cases, the patients had asymptomatic end-organ fragment embolization.

© 2010 William Nicholson, W. Jay Nicholson, Paul Tolerico, Bradley Taylor, Samuel Solomon, Thomas Schryver, Kevin McCullum, Howard Goldberg, James Mills, Brian Schuler, Larry Shears, Lyle Siddoway, Nikhilesh Agarwal, and Christopher Tuohy, Prevalence of Fracture and Fragment Embolization of Bard Retrievable Vena Cava Filters and Clinical Implications Including Cardiac Perforation and Tamponade, Archives of Internal Medicine 170(20): 1827-1831, DOI:10.1001/archinternmed.2010.316 (08 November 2010) (paragraph split)

Nicholson group’s conclusion regarding the filters’ life-threatening performance

The Nicholson team concluded that,

The Bard Recovery and Bard G2 filters had high prevalences of fracture and

embolization, with potentially life-threatening sequelae.

Now think about the population affected by these filters

Rita Redberg expressed concern about the magnitude of Nicholson’s findings:

Extrapolating this data for the 65 000 G2 filters that have been implanted suggests that more than 7000 Americans may now be carrying a fractured G2 filter, with the potential to embolize to the IVC [inferior vena cava] and beyond.

Moreover, although the devices were approved as retrievable, the data suggest removal is not simple: less than 7% of devices were removed according to the article by Nicholson and colleagues. The safety of removal of the device after long-term use is not well established.

Imagine you are one of these 65,000 Bard® vena cava filter patients

Consider three facts:

(i) Embolisms often kill suddenly and without warning.

(ii) According to Nicholson’s results, each of these 65,000 Bard® vena cava-filtered people have manufactured “embolism bombs” implanted inside them.

(iii) These patients probably do not live in, or next door to, emergency medical facilities.

Therefore ─ not only are these people going to be wondering:

(a) when their filter is going to break and send off bits of itself (and what it has collected) inside their bodies,

but

(b) they will also be wondering, whether they will have enough warning to call for, and get to, the medical assistance required to prevent sudden death.

How would you like to live like that, especially courtesy of (a) a manufacturer’s failure to test its money-making device and (b) the government’s complete failure to check the device for workability and safety?

Gross dereliction of FDA duty

Dr. Redberg continued her indictment of the FDA’s inexcusable regulatory sloppiness in the Bard filter case:

Remarkably, these filters, which are placed inside the IVC [inferior vena cava], were considered Class II by the FDA ─ the same risk category of mercury thermometers ─ and received approval without any clinical data of safety and effectiveness . . . .

Conclusion ─ who put these people in office?

What level of moron-i-tude does it take think that we can place a:

(i) potentially thrombus-creating,

(ii) perhaps fracture-prone device,

(iii) inside a huge central vein ─

without creating high level of medical risk?

Class II medical device? What imbeciles thought that was appropriate?

This is the same level of gross governmental incompetence (or effectively “bribed” non-regulation) that marked the Minerals Management Service’s issuance of a drilling permit to BP in the Gulf of Mexico─ under conditions in which it was clear that the company had no clue regarding how to cope with an oil well blowout 5,000 feet under water.

These are the people we let run our federal government.

PeteFree.com

If You Thought the Food and Drug Administration Competently Regulates the Safety of Implanted Medical Devices, You Guessed Wrong Enough to Get Yourself Killed