Surgical staplers are used millions of times each year to close internal surgical incisions in bariatric patients and for other gastrointestinal procedures, gynecological surgeries and thoracic procedures.
Surgical staplers work by simultaneously cutting tissue and stapling the tissue back together during surgical procedures. In gastric bypass surgeries, for instance, the incision and stapling is made for the purpose of making the stomach smaller.
Though surgical staplers can provide a benefit to patients, many designs are fraught with problems that can lead to disastrous results.
Staplers can misfire and not staple the tissue at all points or they can staple part instead of all of the tissue that has been exposed by the instrument. Defective staplers can result in a “C” shape to the staples when placed on the tissue instead of the familiar looking fully closed staples one would see when non surgical staples are used on paper.
Misfires and malfunctions of surgical staplers are caused, in part, by the design of the stapler, and in part by issues with the instructions for use. For instance, physicians are told they should measure the tissue which is being stapled so that the proper size stapler and staples can be selected. The manufacturer is aware, however, that it is not possible for the physician to follow those instructions because there is no method and no instrument which will accurately measure the thickness of tissue in a closed surgery.
On March 8, 2019, after years of problems with staples misfiring the FDA issued a report raising concerns about the safety of medical staplers.
“Today, the U.S. Food and Drug Administration issued a Letter to Health Care Providers to alert them that the agency is aware of an increasing number of medical device reports associated with the use of surgical staplers for internal use and implantable surgical staples—common devices used in many surgeries—and to provide updated recommendations to help reduce risks associated with their use.”
FDA News Release, May 8, 2019
The FDA went further in its communication, warning of the number of reported adverse events with surgical staples.
Lawsuits involving surgical staples are currently being filed by the Martin Baughman law firm. Martin Baughman has been a leader in the surgical staple litigation and attorney Ben C. Martin obtained one of the first verdicts ever in a surgical stapler case. That case arose from the tragic death of a young mother who was the victim of a surgical stapler misfire. That stapler was manufactured by Ethicon Endo-Surgery, Inc., the leader in market share of surgical staples, Ethicon Endo-Surgery, Inc. was found liable by a jury in Dallas County, Texas, for the death of the patient. Gillies v Ethicon Endosurgery, Inc., Dallas County, Texas verdict, 2009.
Martin Baughman continues to pursue surgical stapler cases involving injuries caused by staplers manufactured by Ethicon and other medical device companies, all of which are currently under scrutiny by the FDA as well as the watchful eye of Martin Baughman.
If you or a loved one has been affected by medical negligence, a failed medical device, a pharmaceutical issue, catastrophic injury or wrongful death, we can help. Fill out this form or call 214.761.6614 for a free consultation.