blog.bioethics.net

This Product Recall Will Hurt a Lot

Defective heart devices already implanted in lots of folks - devices made by Guidant Corporation, a company soon to be acquired by Johnson & Johnson (unless J&J decides that uh, maybe these guys might be very expensive as a subsidiary...) - are defective, or at least many of them may be, according to recent releases. The devices are internal defibrilators, and the problem is that they can short-circuit when they are called on to restore cardiac rhythym. If they do, you can die.

Writes the Times:

Guidant did not tell doctors for over three years about the electrical flaw in one model, the Ventak Prizm 2 DR Model 1861, that it has recalled. It also kept selling older versions of it after developing a version not prone to short-circuiting ...

The surgery to replace a defibrillator, which is the size of a pager and is implanted under the skin of the upper chest near the shoulder, takes an hour, and many people go home immediately afterwards. Full recovery takes about 7 to 10 days. But like any surgical procedure, the surgery carries a risk of infection.

About 17,000 people, 13,900 of them in the United States, are still implanted with the affected Prizm 2 DR devices, which are those made before April 2002, when Guidant fixed the problem. Another 11,900 people, 6,700 of them in this country, still have the affected Renewal devices, made before last August. The Renewal devices - more complex defibrillators intended for patients with severe heart failure - have pacemaker functions for both sides of the heart.

This isn't the first such device to be recalled. But it is definitely one of the more invasive procedures for removal, and the question of safety trade-off will be enormous, as will the question of who pays for what sort of injury and prevention.