For many years, defective surgical staples have caused irreparable harm to patients, but these dangers remained hidden. In 2019, the Food and Drug Administration (FDA) acknowledged that thousands of surgical staple malfunction reports were hidden from the public. Here, the medical device litigation team at Peter Angelos Law discusses the various companies under scrutiny for defective surgical staple malfunction and the injuries they continue to cause.
Concealed FDA Database Left Patients Unaware of Potential Dangers
Surgical staples are primarily used during minimally invasive procedures to seal skin or tissue during surgery. Because of their frequent use, defects, including misfired of staples, puncture wounds, and deformed staples left in the tissue, have caused tens of thousands of serious and potentially fatal injuries to patients. Some of the more common injuries include:
- Re-opened surgical wounds along the staple line
- Organ damage
- Fistula formation
In 2019, the FDA announced that over 110,000 malfunctions or injuries caused by defective surgical staples from 2011-2018 avoided required public disclosure in an FDA database. Instead, the surgical staple manufacturers were allowed to send these reports to the Alternative Summary Reporting Program. These private submissions kept the public in the dark about the dangers of these defective surgical staples and staplers.
Companies Remain Under Scrutiny For Inadequate Reporting
To date, more than 3.4 million staplers have been recalled, and many large corporations that have enjoyed massive profits from selling these defective products are finally being held to account for the injuries and deaths they have caused. Medtronic and Ethicon, a subsidiary of Johnson & Johnson, are just a few of the manufacturers that have faced litigation in recent years following Class I recalls of their staplers.
When the hidden stapler malfunction data was finally made public, we learned that at least 412 deaths and tens of thousands of additional injuries have been caused by these products.
Discuss Your Rights With a Medical Device Liability Attorney at Peter Angelos Law
Medical device defects and malfunctions are a leading cause of catastrophic surgical injuries and when companies are allowed to conceal these defects, many patients are left with severe injuries and staggering medical bills, yet never know that their pain and suffering could have been prevented. If you or a loved one has been injured during a surgical procedure, your injury may have been caused by a defective medical device. Contact the Law Offices of Peter Angelos Law today for a free consultation with our experienced litigation team.