Hidden FDA Databases Concealed Life Threatening Injuries Due To Surgical Staplers And Internal Staples
A bombshell article by Kaiser Health News has revealed that the U.S. Food & Drug Administration allowed surgical stapler manufacturers and other medical device companies a special exemption allowing them to report instances of serious and, at times, deadly device malfunctions in a hidden database. These vital records were concealed for years leaving the public and medical professionals in the dark about thousands of device failures that led to severe injuries.
Just days after publication, the FDA released a detailed letter to medical professionals about the dangers of surgical staplers and internal staples based on a number of adverse events. Over seven years, from 2011 to 2018, the agency received more than 41,000 medical device reports on this common surgical instrument which included:
- More than 32,000 malfunctions
- Over 9,000 serious injuries
- 366 deaths
Meanwhile, these surgical staplers are still being used in almost every operating room in the U.S. during gastrointestinal, thoracic, gynecological surgeries as well as for many other procedures. Surgical staplers and internal staples are used to quickly close wounds, remove organs, cut through organs or tissue and connect internal structures.
Stapler devices and internal staples often are used in place of suturing because they can be placed and implanted into tissues and internal structures quickly allowing for faster surgeries. However, injuries due to staplers misfiring, difficulties in firing or failing to fire can lead to longer surgical procedures and the need for emergency surgical interventions. Post-operative complications can include:
- Risk of increased cancer recurrence
- Fistula formation
If you or a family member have been injured by a surgical stapler or internal surgical staples, Meyers & Flowers can help you explore your legal recourse options. We can be contacted at firstname.lastname@example.org, 877-221-2511 or online.