In an attempt to force greater transparency in the medical device industry, the FDA is ending alternative summary reporting. This will end two decades of a practice that, for too long, has enabled the medical device and pharmaceutical industries to hide injury reports due to defective health care products – including surgical instruments and breast implants.

Twenty Years of Secrets

The FDA’s alternative summary reporting, or ASR program was quietly instituted in October 1999. It allowed medical device manufacturers to submit reports of device malfunctions in a non-public FDA database, preventing the public and even practitioners from accessing them.

The ASR program got very little in the way of public notification. According to the exposé that appeared in Kaiser Health News in March 2019, many doctors and medical safety engineers knew nothing about it, and a former FDA commissioner said he was never aware that the ASR program even existed.

One surgeon interviewed for the story who experienced a serious malfunction with a surgical stapler said, “It seemed like a cover-up.”

Although deaths due to a defective device must still be reported through the Manufacturer and User Facility Device Experience (MAUDE) database, medical device manufacturers whose products had malfunctioned and caused injuries could still use the Alternative Summary Reporting program by making an “Exemption Request.”

Excuses

One FDA official told KHN that the ASR program was for issues “well-known and well-documented” within the agency, and that reforms had been put in place in 2017. That reform was a “voluntary summary reporting program” that covered as many as 5,600 devices.

Yet despite “reforms” and updates over the past two decades, the program has remained obscure and unavailable to the general public. It took investigative reporters several months before the FDA even acknowledged that Alternative Summary Reporting even existed.

An FDA spokesperson says that the exemptions allowed the agency to “… more efficiently review adverse events … and take action when warranted without sacrificing the quality of our review or the information we receive.” It is difficult to understand how this would be the case when it essentially has amounted to the FDA surrendering its oversight authority over the industry.

Critics say this obscurity and secrecy has resulted in hundreds of thousands of needless injuries, and has spurred massive amounts of litigation.

Alternative Summary Reporting Hid Millions of Incidents

In 2016 and 2017 alone, over 1.5 million injuries and malfunctions were reported through the ASR program. Another million or so reports filed over a 15-year period are still inaccessible by the general public.

It is possible to submit a Freedom of Information Act request about a given incident, but it can take as long as two years to get a response.

Breast Implant – Cancer Link Reports Hidden

Following publication of the KHN exposé, the FDA convened a panel for the review of injuries and diseases attributed to breast implants.

During that meeting, the committee addressed many reports of women who developed Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) as a result of having textured breast implants. Incredibly, the FDA announced that it would not require the manufacturers of textured breast implants to issue a recall for the product; they currently remain on the market.

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This article is not legal advice. It is presented
for informational purposes only.