Harvard Researchers Take FDA's Device Approvals to Task

Jane Akre
April 2, 2014
Sprint Fidelis wire

Sprint Fidelis wire

Using documents that recently came to light, Harvard researchers have traced a troubling approval process within the Food and Drug Administration that allows medical devices to be sold with little oversight.

Essentially the supplemental application resembles the agency’s 510(k) process that allows medical devices to be marketed without clinical trials.

The paper is reported in the Journal of the American Medical Association (JAMA) here.

The New York Times highlights the case of two devices, both implanted cardiac devices considered high-risk and approved at one time under the Premarket Approval (PMA) the standard that requires clinical trial to assure patient safety.

The researchers looked at how the St. Jude Medical heart defibrillator, implanted in thousands of people, and the Sprint Fidelis cardiac devices made it to market. Both had wires that failed to do their job of shocking a heart back into a regular rhythm. Both injured and killed patients and both were later recalled. See NYT story here. (An earlier version of this story said the two devices underwent the 510(k) approval. They actually were approved by the supplement process.).

The Times calls supplemental approvals “a little-known process."

A supplemental application is filed when a company wants to make changes to a product that has been approved. The change can occur throughout multiple versions of the device with no clinical trials required. In the end, the device many not resemble the original device.

For example, the St. Jude defibrillator and its recalled wire was approved in 1996 but had been revised 78 times. The Sprint Fidelis faulty lead had been modified 91 times. In fact the last time an implantable defibrillator underwent a PMA was in the year 2000.

Harvard researchers report in the case of heart defibrillators, follow-up generations can change the electronics and wiring and still receive approval “without testing the changes in a single patient.”

For each device that went through the full premarket approval process, 50 subsequent changes were made, the NYT reports.

Between the years 1979 to 2012, the FDA allowed 77 implanted devices for the heart such as pacemakers and defibrillators to be approved as well as 6,000 supplemental applications.

Supplemental applications have increased ten-fold from 70 to 700 a year over the last decade, reports the Times. Readers may want to add their comments under the NYT story.


The fact is that the vast majority of medical devices implanted and used on Americans bypasses any regulation and oversight. Supplemental approval is one way. 510(k) is the other.

Readers of Mesh News Desk already understand that surgical mesh for hernia repair and transvaginal pelvic mesh were all approved under the 510(k) process.

The process begins with paperwork. A manufacturer who wants to introduce a new medical device, sends an application to the FDA along with naming a "predicate" device that is the "substantial equivalent' of a device already being sold. Never mind that it may have a different design, different electronics and may be made of different materials.

The manufacturer is seeking an approval to sell the device. About 90 percent of medical devices make it to market this way.

prolift box 200

Manufacturers and their lobbying organization, AdvaMed, like the 510k) because it allows devices to market faster, within two months and at a minimum cost of under $5,000. A PMA application can cost millions and take years.

AdvaMed says this is an advantage to the public because it allows devices to make it to market faster without the higher degree of scrutiny.

Advamed logo 205

In the past when the FDA has suggested changes to the 510(k) process, as advocated by the Institute of Medicine in 2011, AdvaMed pushed back. See background story here.

Surgical Mesh and 510(k)

See our Feature story 510(k) Safety Forgotten here.

Readers of Mesh News Desk already that unlike faulty heart defibrillators, polypropylene and other materials that are used for surgical mesh remains on the market even as there are at least 75,000 court cases filed and even though it too was approved via the 510(k) process.

ProteGen mesh was removed for being “adulterated” and “misbranded” but that did not stop it from being used as the predicate for a family of meshes that followed. Kugel hernia mesh was recalled for a plastic ring break but later was put back on the market.

Mesh Recalls

Without calling it a recall, four models of Johnson & Johnson mesh were voluntarily removed from the market in June 2012. They include Prolift mesh kit, Prolift M+, TVT Secur and Prosima surgical meshes. The reason given by the healthcare giant was “ ‘commercial viability’ in light of changing market dynamics and is not related to safety or efficacy” according to the company.

Instead of recalling it, Johnson & Johnson changed the label on the Gynecare Gynemesh PS. Its use would be restricted for use in abdominal sacrocolpopexy procedures for the treatment of pelvic organ prolapse. In other words, it would no longer be indicated for use in transvaginal surgeries and would only be inserted through an incision at the bottom of the abdomen.

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