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Shapiro, Lewis, Appleton & Favaloro, P.C.
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FDA Issues a Class I Recall of Surgical Staplers

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On October 26, 2012, the FDA issued a Class I recall of three different surgical staplers that are manufactured by Ethicon, a subsidiary of Johnson & Johnson. A Class I recall is the most serious recall category in which there is a high probability that the product being recalled could cause injury or even death. Users of the staplers have reported difficulties in getting the staplers to work properly. If the staplers do not fire right, the circular or semicircular staples may not close completely, leading to serious complications.

The staplers in question were sold between April 2011 and July 2012 and are used in the repair of anorectal tissue for problems such as hemorrhoids or prolapse. According to the FDA, issues that may result from the use of these defective staplers include “severe pain, sphincter dysfunction, rectal wall damage, sepsis, bleeding, occlusion of the rectal canal… dehiscence of the rectal wall staple line and bleeding.”

Medical personnel who purchased the defective devices will be notified by mail and are asked provide information on whether or not they have the devices and if they will be returning them. It is unclear if patients who were treated with these devices will be notified. If you have had this type of surgery recently, you may want to contact the doctor who performed the procedure to determine if you might have been affected by the recall. If you are suffering from any of the adverse conditions listed above, seek medical assistance immediately.

Our firm provides answers to many questions regarding defective medical products and dangerous drugs here. These situations are unfortunately more common than any of us would like to believe.

About the Editors: Our personal injury law firm has offices in Virginia (VA) and North Carolina (NC). The attorneys with the firm publish and edit articles on three Legal Examiner sites for the geographic areas of Virginia Beach, Norfolk and Northeast North Carolina as a pro bono service to the general public.

MH