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FDA Calls Surgical Staplers and Staples Unsafe

FDA Calls Surgical Staplers and Staples Unsafe

The Food and Drug Administration (FDA) has released reports detailing more than 56,000 medical malfunctions related to surgical staplers that were reported between 2011 and 2018. Many of these reports were not previously disclosed to physicians or the public.

These reports detailed malfunctions related to various brands of medical grade surgical staplers. After analysis, the FDA proposed reclassifying internal surgical staplers from Class I—which is regarded as generally controlled and regulated—to Class II. This change in classification would entail premarket review of all internal surgical staplers and staples before they could be used in a medical setting. Discussion of separating internal and external staplers into specific classes is also under review by the FDA.

Complications with Surgical Staplers

The FDA released a letter in March of 2019 to healthcare providers that included reports of frequent problems with internal surgical staplers. Common difficulties cited in many of the reports included complaints that the staplers would misfire into incorrect tissue, that the stapler itself would lock up, that the stapler would not fire at all, and sometimes, that the staples would be malformed within the stapler itself. In total, over 9,000 serious injuries and close to 400 deaths were caused by these frequently reported malfunctions.

The reports also detailed common health-related complications after a defective stapler or staple were used. For some, the internal medical staplers would cause fistulas to form, internal bleeding, sepsis, tearing of internal organs and tissues, and even death.

Those who were injured or witnessed a loved one die due to device-related malfunction have expressed anger at the hidden network of reports and databases that track the failure of these medical devices. While some medical products have well known databases to track side effects, issues, and warning signs, those who experienced injury due to internal staples or medical staplers were not informed of the potential side effects of this medical product. Furthermore, if a reporting program or database for medical stapler device failures did exist, some physicians and patients cited that they were not made aware of the outlets they should check.

Determining Liability

In instances of defective medical instruments, there is the opportunity for a person to file a product liability claim in tandem with the opportunity to file a medical malpractice suit. While a person’s injury may be due to stapler malfunction, there could also be the element of a physician’s error. A surgeon has a standard of care for their patient, similar to the duty of care a product manufacturer has for those who use their product.

As a result, major manufacturers for medical staples—such as Covidien, PLC, and Ethicon— might be held accountable for fatalities or injuries associated with their staples and defective medical devices. While the necessities for filing a malpractice claim and a product liability claim differ, there could still be opportunities to receive damages against multiple neglectful parties, such as a physician or manufacturer.

Contact an Experienced Attorney Today

We understand how discouraging and frustrating it is to go to a medical professional for the treatment of one medical condition, only to end up with the pain and distress of another. If you wish to file a medical malpractice or a product liability claim regarding defective staples or a faulty medical stapler, it is important that you obtain the help of legal counsel that has experience in these areas of the law.

The attorneys at the Whitley Law Firm have more than 80 years of combined experience helping individuals claim the financial damages they rightfully deserve, and we might be able to help you too. With compassionate and responsive legal representation, we could aid you in understanding your situation and the path your legal battle could take in the future.

Do not hesitate to reach out to our dedicated legal team today. We could explain your legal rights and work to get you the compensation you deserve.