Senator Boxer calls for FDA Accountabilty For Medical Devices

Some of you maybe remember the great post on the Beauty and the Breast blog Supreme Court Rules You Can’t Sue Medical Device Makers Because the FDA Does Such a Great Job Assessing Safety?

In response to the ruling, Senator Barbara Boxer (D-CA) introduced a bill last week that would bring greater accountability and transparency to the Food and Drug Administration’s (FDA) regulation of all medical devices. Millions of Americans are implanted with devices ranging from pacemakers to breast implants, yet don’t realize that medical devices are not rigorously approved like pharmaceuticals. The bill (S.3020), the Food and Drug Administration Accountability and Transparency Act, will provide the FDA with several tools to help ensure the safety of these devices.

Because of less stringent safety approval mechanisms, the FDA allows manufacturers to conduct post-approval studies. But in many cases these studies are altered or not completed and consumers are left in the dark about safety problems.

“The FDA has been charged with a central role in safeguarding the health of our nation. Since the creation of this agency more than 100 years ago, the role of the FDA has expanded to ensuring the safety of foods, drugs, medical devices, and even cosmetics. Too often, however, the FDA lacks the authority or the resources to safeguard the health of our nation….[this act] would give the FDA several tools to ensure the safety of medical devices, including larger fines to hold these companies accountable,” Senator Boxer said.

Medical device manufacturing is a $75 billion industry, with considerable lobbying power, which enables them to secretly waive or alter post-approval agreements with the FDA, without informing consumers. This bill would end this practice by requiring such changes to be placed in the Federal Register.

Senator Boxer also stated: “If the Secretary of Health and Human Services determines that a manufacturer’s failure to conduct post-market surveillance is a risk to public health, this legislation give the Secretary the authority to notify health professionals that have been using these devices about any safety concerns.”

Sybil Niden-Goldrich, a long-time advocate of the breast-implant issue, applauded Senator Boxer: “More than 360,000 women received breast implants last year—a 40% increase over the last five years. Yet none of these women knew silicone implants were approved on the basis of post-approval studies that subsequently were watered down by FDA and aren’t being conducted. Senator Boxer’s bill would correct these grave injustices.”

Breast reconstruction and infection: you be the judge

The NYT has run a couple of articles this week on breast implants. I might eventually come back to blog about the first one, but today, it's the second that's got my goat.

The second one reports on a research study published in Archives of Surgery (abstract). The NYT article reports, accurately, that the study found that women whose post-mastectomy reconstruction used silicone implants instead of women's own tissue were twice as likely to acquire infections. But there are a couple of interesting things you might notice, if you go look at the abstract.

One is that the absolute risk of infection in these procedures is 12.4% for women with implants, and 6.2% in women whose reconstructions don't involve implants. Double, yes, fair enough. But the abstract also notes and that women who had mastectomies without reconstruction had a 4.4% risk. So...a fairly substantial increase in relative risk occurs between women who forego reconstruction and those who have it, with still higher risks for those who also choose implants. But if you look at the news reports, no-reconstruction, interestingly, is not even reported on as a possible choice. How come? (No hate mail, please: I don't in any way mean to imply that women should or shouldn't have reconstructive surgery, only that the way this particular study has been reported in the popular press is somewhat misleading.)

If you look at the abstract yourself, you might notice a few other things that might give you pause. The study included only 50 women in total--not a very substantial sample size. And the finding that was picked up by the media was incidental to the primary finding of the project, which focused on the economic costs associated with such infections. Also, the study sample was women on their initial hospital admission for the mastectomy/reconstruction procedure, and women who were readmitted...which could conceivably leave out women who *didn't* experience infections as a result of these surgical procedures.

Given how much of our health information comes to us through media filters, we need to be savvy consumers of that information. We need to understand how research works, so that we don't uncritically accept the media spin of research reports. Something happens to research results when they are morphed into news bites...and if we're basing health care decisions for ourselves and our families based on that information, we've got to know how to read critically. It's my hope that we can educate ourselves about how to be more critical consumers of media products. At the same time, I'd like to see women apply judicious pressure on the media to step up to the educational role, and not just pursue the latest bright shiny object.