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Heart rings get a pass: Annuloplasty rings hit the market without clinical studies to show they are safe.
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By Deborah L. Shelton and Jason Grotto
When U.S. Sen. Chuck Grassley started asking questions in 2008 about a heart valve repair device called the Myxo ETlogix annuloplasty ring, it piqued our interest. A Chicago-area patient had complained to him that the ring had not been approved by the U.S. Food and Drug Administration before it was implanted into her heart. A spokesperson for the ring manufacturer told the Tribune that the company was voluntarily recalling it and submitting an application for approval.
We couldn't help but wonder: How does a medical device get implanted into patients without first going through the FDA?
That question lead to our two-day series that ran in the Chicago Tribune in late May that reported for the first time the rings had been "down-classed" from class III to class II, a regulatory category that required that they undergo less scrutiny, even though the devices are permanently implanted and life-sustaining.
The ring, we learned, was one of two annuloplasty rings produced by the same company, Edwards Lifesciences, which had been stitched into the hearts of at least 700 patients in Chicago and elsewhere without going through proper channels. In fact, even though the company could have submitted both rings for clearance through a less rigorous regulatory pathway known as 510(k), it didn't even do that. In these two cases, the process was skipped in its entirety.
We started out researching two rings but found a much broader and more important story about how all annuloplasty rings fail to get scrutinized the way they probably should. The two we looked at didn't get scrutinized at all.
In reporting this story, we used a handful of key documents and databases that allowed us to track the reclassification of annuloplasty rings. First, we used the Federal Register to build a regulatory history of the rings. To do this, we started by looking up the regulations for the device using the FDA's Code of Federal Regulations Title 21 database.
At the bottom of the regulation, there is a volume and page number from the Federal Register, which tells when the regulations for the device changed and the reasoning behind the change. Once we had that, we went to the Federal Register and tracked the regulations all the way back to 1976, when the medical device laws were first put on the books. (Because not all of the registers are online, we had to use microfiche for older entries.) When the medical device laws were first put on the books, a panel of experts put annuloplasty rings in class III, which means they were supposed to require clinical trials to gain approval. First, however, the agency had to write regulations requiring clinical trials.
About 15 years later, when the FDA finally began promulgating those rules, known as Premarket Approval or PMA, it requested all of the data and other information that manufacturers had on the rings. The FDA also said that a petition could be filed to reclassify the device.
AdvaMed, the medical device industry's trade group, petitioned the FDA in 1997 to have annuloplasty rings reclassified. The FDA reclassified those rings in 2001. Included in every Federal Register entry is a docket number. We FOIA'ed all of the documents from the docket numbers looking for the petition requesting the reclassification. This would normally be the next step in figuring out how the reclassification happened. However, the FDA failed to include the petition in the docket. A lesson learned: If you don't find a petition for a reclassified medical device in the docket, it doesn't mean it's not there. We ended up asking the FDA directly for the petitions, which it provided.
The final piece of the puzzle is the internal memo from FDA, called a "Reclassification Decision Making Document," which outlines the agency's reasoning for the reclassification. In this case, it turned out that the memo was a cut and paste job, which raises questions about how much scrutiny the reclassification actually received. This is important because the FDA has been under tremendous pressure to either write PMA rules for pre-amendment class III devices or reclassify them. The easier, less resistant pathway for the agency (which is grossly underfunded and constantly pressured by the industry) is to reclassify these devices.
Tricuspid valve in a model heart. (Photo by robswatski via Flickr)
To tell the stories in human terms, we turned to patients. An earlier story included an interview with the patient who first discovered that something was amiss. Her story was so compelling that we decided to describe in greater detail how she realized that the annuloplasty ring implanted in her heart was not cleared by the FDA. A second patient filed a lawsuit but didn't want to be interviewed. It took several weeks of persuasion before she agreed to talk to us. We located another patient through a Chicago medical malpractice attorney, and a fourth patient contacted us after reading a Tribune story about the ring published last year. Neither patient wanted to go public, but one eventually agreed. We featured him in the first day's story. The other patient remained off-the-record but provided us with helpful background information and documents.
We spent a lot of time trying to get sources on the record. Patients didn't want their medical problems exposed publicly, or they had other reasons for wanting to maintain their privacy. Most of the doctors we spoke to insisted on remaining off-the-record, reluctant to be interviewed about a nationally renowned colleague. Even so, they provided important background information and gave us feedback during and after the reporting.
Millions of Americans are recipients of medical implants of one kind or another – anything from hip to dental to brain implants. Their numbers are growing as our population ages and technology advances. These surgeries are invasive, risky and costly. That makes oversight of medical implants a huge story, and an area of reporting that can be mined for many important stories, regardless of where a journalist lives or works.
Deborah L. Shelton and Jason Grotto are reporters on the Chicago Tribune's investigative/consumer watchdog team.
