Surgical Staple Injuries

Manufactured by Ethicon in 1999, the gastric bypass stapler was introduced. A subsidiary of Johnson and Johnson, Ethicon, since then has been cited with this device in a number of complaints as being unsafe and unreliable.

The Food and Drug Administration, over a period of 15 years, received more than 9,000 reports of harmful incidents related to the device; more than 90% of the reports mentioned the failure of the gastric bypass stapler as the cause of harm in many cases.

The two main manufacturers of gastric bypass staplers in the United States, despite this information, continue to reject blame, and place it upon surgeons, while neglecting to improve design of the product in order to address concerns of safety.

A procedure which divides the stomach into two separate parts, gastric bypass could affect one, that is a tiny upper pouch, and another, which is the rest of the human stomach.

Attached to the stomach of the larger portion is the small intestine, so there is an established connection, which enables the pouch to link to the small intestine to help in digestion.

A patient typically eats less due to the fact the stomachs upper portion becomes full easily, which results in an appetite that is under control.

A device that enables surgeons to close incisions made within procedures, the gastric bypass stapler is supposed to be effective since cuts for stitches are too large.

Reports have cited the gastric bypass stapler being problematic due to a failure to fire staples properly, an inability to form correct staples, and inserting faulty staples which subsequently fail to keep closed the incision, or come loose.

Injuries sustained which may result from using a substandard stapler entail the following: internal bleeding as a result of the failure to close a wound, or from the site of the staple; stomach acid leakage from areas after administering the procedure which reopen; infection from the incision or the site of staple; a resulting hernia from the failure of the stapler to operate; an infection which reaches the bloodstream, septic shock, that travels to major organs; injuries which stipulate revision surgeries; and in the most catastrophic cases, death.

Sold in the United States, of all gastric bypass staplers, Ethicon has a market share of over 60% currently, while US Surgical controls the other 40% of the market.

Related to gastric bypass staplers, rather than responding to reports of the negative incidents, by a recall of products, or at least an improvement in designs, these manufacturers decided to allow medical professionals to take the fall instead.

Repeatedly, Ethicon has alleged that the malfunctions in the equipment are due to human error. However, it is becoming abundantly clear that they are responsible for the defects in the devices, not the surgeons, in virtually 10,000 adverse circumstances.

You do not have to remain a victim of surgical staple injuries.

Contact us for a free consultation or call Anzalone Law Firm PLLC, at: 603.548.3797