The United States Food and Drug Administration (FDA) holds the responsibility of ensuring that medical devices and products are safe for consumer use. When a product malfunctions, the FDA’s MAUDE database is meant to receive submissions of product malfunction. Recently, however, in the midst of the surgical stapler reclassification discussions, it has come to light that the FDA has an Alternative Summary Reporting system.
How Alternative Summary Reporting Affects The Surgical Stapler Reclassification
An executive summary published by the FDA has made public over 56,000 previously private surgical stapler malfunctions that were covertly reported to the agency between 2011 and 2018. These newly identified reports have changed the face of the surgical stapler reclassification discussion. Their sheer numbers alone have brought the total count of confirmed surgical stapler malfunctions to over 110,000 and their severity has made many FDA officials and consumer activists question whether surgical staplers are still deserving of their Class I status.
A Class I medical device classification is given to “simple” devices such as bandages and tongue depressors, and affords those devices little oversight due to their perceived safety. The proposed surgical stapler reclassification to a Class II medical device would confer with it more rigorous and scrutinizing analysis of the device’s safety and viability for consumer safety.
Alongside this discussion of surgical stapler reclassification is the presence of this FDA alternative summary database. Until now, the public was only aware of the MAUDE reporting database which had data that was publicly accessible. This is made even more troubling by the fact that in 2016 alone, the MAUDE database received 10 times fewer reports about surgical stapler malfunctions than the alternative reporting system. Also disturbing is the fact that although there have been over 400 surgical stapler deaths reported through the MAUDE database, the alternative reporting system does not allow details about potential fatalities to be reported.
After the reveal of the alternative reporting system, surgical staple mainstays: Medtronic and Johnson & Johnson, weighed in. Medtronic has announced that the FDA granted them exemptions for their surgical stapler malfunctions, Johnson & Johnson stated the opposite. Last Thursday, the FDA advisory panel weighed the evidence and made recommendations favoring surgical stapler reclassification citing a need for the additional safety requirements that come with higher-risk classification
The FDA has now come forward formally acknowledging the health risks associated with surgical staplers on their official page regarding surgical staplers and staples. They have also advised against using the staplers on large blood vessels. Surgical staplers have lost their eligibility to report malfunctions through the alternative reporting system in February 2019, and the FDA has announced it would end the alternative summary reporting program entirely in early May 2019. In many ways, it seems that the surgical stapler reclassification may very well go through.
How The Surgical Stapler Reclassification Affects Your Compensation
Though the surgical stapler reclassification decision has not yet been made, the FDA alternative reporting database files have shed new light on the risks and dangers of surgical staplers. Now more than ever, if you or a loved one have been injured, suffered complications, or experienced wrongful death while using surgical staples compensation may be available to you. To pursue your claim to the fullest, you will need a team of experienced trial attorneys who are motivated and prepared to take the fight to these large companies. Those trial lawyers work for Parker Waichman LLP.
At Parker Waichman LLP, our trial lawyers are ready to represent you in your time of need and earn you the compensation to recover your old life again. Don’t wait. Contact Parker Waichman today for a free consultation.
For more information about the risks associated with surgical staplers, see Parker Waichman’s in-depth coverage on our main page here.
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