Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Friday, June 29, 2012

Citizen claims right to safer implant devices.

 Medical devices need impartial oversight

JUNE, 27 2012
My husband has a full hip joint replacement, the kind where they lop off the bone and replace it with a metal rod and ball. Fortunately an easier procedure is now available where they just recoat the ball in the hip joint. But we thank our lucky stars that his metal hip joint is, so far, not causing any problems that we know of.

Many people who underwent the same procedure as my husband have had major problems, requiring repeated surgeries and causing long periods of, if not permanent, immobility.

And that is why I was particularly interested to read an article In “Public Citizen Health Letter” about the $350 billion medical device industry's “massive lobbying campaign to weaken the already lax oversight of medical devices and to accelerate the already too-quick review of high-risk medical products.”

The law setting the Federal Drug Administration's user fees and regulation requirements for both new medical device applications and ongoing oversight is up for renewal this year. And already the members of Congress who have received the most campaign finance help from the industry have introduced 14 bills aimed at easing regulation and weakening measures intended to ensure patient safety.

That patient safety measures need to be strengthened, not weakened, may be inferred from the substantial increase in recalls in recent years. Recalls of devices posing high risk to patients have doubled between 2007 and 2011, and recalls of devices posing moderate risk have increased sevenfold.

And the growth of recalls cannot be explained by any increase in the number of new medical devices, whose number has been stable or declining in recent years.

Among recently recalled devices are:

• Faulty implanted heart defibrillators that incorrectly deliver dangerous electrical jolts to the heart.

Surgical clips that pop off, causing patients to bleed to death internally.

Artificial hips that shed metal fragments into the bone and surrounding tissue, causing extreme pain and restricting mobility.

Infusion pumps that shut down unexpectedly or dispense incorrect intravenous medicine doses.

In the face of this record, the medical device industry spent $33.3 million on lobbying in 2007. In the third and fourth quarters of 2011 there were at least 225 of these lobbyists hard at work, including 107 who had previously worked for the federal government.

Interestingly, one of the bills introduced in Congress would weaken the financial conflict of interest prohibition against individuals with industry interests serving on the FDA advisory committee overseeing medical device approvals.

Members of a key House health subcommittee with jurisdiction over medical devices have received campaign contributions from the industry double those of the average House member. And actual sponsors of the House bills seeking to weaken regulation and oversight have received about three times more.

Public Citizen asserts that in addition to allowing far too many dangerous devices to reach the market, the FDA has inadequate post-market surveillance for adverse advents. The FDA primarily depends on manufacturers and hospitals to report incidents of serious injuries or deaths related to these devices. It is not in the manufacturers' or hospitals' interest to do so.

Furthermore, Public Citizen points out, the Republican-dominated Supreme Court held in 2008 that manufacturers of FDA approved devices cannot be held liable for harms. Congress should restore patients' rights to sue in such cases.

Public Citizen calls on Congress to replace the current weak medical device regulatory regime with a process that requires the same scrutiny as that given to new drugs, particularly for moderate and high-risk devices that are permanently implanted in the body.

The whole situation is just one more sad example of our desperate need to amend the Constitution to overturn the Supreme Court's disastrous Citizens United ruling that corporations are people and the Constitution's free speech guarantee protects their right to spend all the money they want to influence Congress.

Only then can we revamp our election process to get campaign contributions out of the picture. And only after that is done, could legislation possibly be enacted to end the “revolving door” between industry regulators and lobbyists.

For further details, go online to And write your representatives and senators.

— “What Do We Really Want?” appears on the second and fourth Thursdays of the month. Mary Boland is a retired teacher and journalist, a proud grandmother, and a longtime resident of Carbondale. Follow her on twitter@grannyboland.

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