Recent Finding Reveals Over 50k Surgical Stapler Complications Were Reported to a Hidden FDA Database
Surgical staplers are routinely used in a variety of procedures to cut tissue and vessels and quickly seal the tissue back up. Surgical staplers do not always operate as intended, having the potential to malfunction and cause patients to sustain serious injuries, such as extensive internal bleeding. In some cases, injuries may be fatal.
Device malfunctions reported to the United States Food and Drug Administration (FDA) are typically available to the public in the MAUDE database, which stands for Manufacturer and User Facility Device Experience. Upon recent discovery, a substantial number of surgical stapler malfunctions and associated injuries were being kept in a secret FDA database.
According to Kaiser Health News, from 2011 to 2018, more than 56,000 surgical stapler malfunctions were “quietly” reported to the FDA, where the malfunctions were listed in a database not available to the public. The “secret” compilation of surgical stapler complications was acknowledged by the FDA in a letter to doctors, which stated that “many more device malfunction reports” were reported to the FDA than what was publicly disclosed.
When counting the 56,000 unknown surgical stapler malfunctions and the publicly known surgical stapler malfunctions, the total number of complications reaches nearly 110,000 from 2011 to 2018. According to one doctor in Michigan, “[e]very surgeon I have ever worked with has had stapler failures.”
Because of the large number of surgical stapler malfunctions and injuries, the FDA advisory panel is recommending that surgical staplers be placed in a higher-risk classification for medical devices. When a device is placed in a higher-risk category, manufacturers of these medical devices must meet more stringent testing and safety requirements.
Who Are the Manufacturers of Surgical Staplers?
The companies that manufacture the most-used surgical staplers are subsidiaries of pharmaceutical giants Medtronic and Johnson & Johnson. Medtronic asserts that it was granted an exemption by the FDA for reporting stapler-related malfunctions to the FDA’s hidden database. Johnson & Johnson, on behalf of Ethicon, Inc., the subsidiary that manufactures medical devices, asserts that it did not have the same exemption as Medtronic.
Surgical Stapler Injuries – Here’s What You Need to Know
Surgical stapler injuries that many patients have reported include, among others, the following severe injuries:
- Internal or excessive bleeding;
- Formation of fistulas, which are sores or ulcers caused by inflammation that form on the inside wall of the intestine and/or nearby organs (fistulas can lead to severe infection);
- Damage to internal tissues and organs;
- Permanent injuries to the digestive system or the development of chronic digestive conditions or diseases; and
- Cardiac arrest secondary to blood loss.
Surgical stapler injuries will be dependent upon how the surgical stapler was used. Patients who experience the most severe injuries typically undergo procedures involving the stomach or intestines as well as procedures involving the head. Regardless of how surgical stapler injuries happen, patients deserve to seek recourse for suffering permanent damage caused by a defective medical device.
Contact the Surgical Stapler Lawyers of Searcy Denney Today
Did you suffer an injury involving surgical staplers used during a procedure? If so, you may have an opportunity to pursue legal action against the manufacturer of the surgical stapler that caused you harm. However, time is limited to file a claim, so it is crucial to act quickly.
At Searcy Denney, our team of skilled surgical stapler lawyers has extensive experience and knowledge concerning defective medical devices and an understanding of the types and severity of injuries associated with surgical staplers. To find out how Searcy Denney may be able to help you, contact our office today by calling (800) 780-8607 to receive a free case evaluation or by completing a case inquiry form on our website.