The gastric bypass stapler was first manufactured in 1999 by Ethicon, a subsidiary of Johnson and Johnson and since then the device has been cited in numerous complaints as being unreliable and unsafe. Over a period of fifteen years, the FDA received over 9,000 reports of adverse events related to the device and over 90% of the reports cited the failure of the device to work as intended as the cause of harm. Despite this information, the two primary manufacturers of gastric bypass staplers in the nation continue to deflect blame back upon surgeons while refusing to improve product design in order to address safety concerns.
How Gastric Bypass Staplers Function
Gastric bypass is a procedure that divides the stomach into two different parts— one of which is a very small upper pouch and the other which is the remainder of the stomach. The small intestine is attached to the larger portion of the stomach, so a connection is established that allows the upper pouch to connect to the small intestine to aid in digestion. Patients eat less because the upper portion of the stomach becomes full more quickly, resulting in a controlled appetite.
The gastric bypass stapler is a device that allows surgeons to close the incisions that have been made during the procedure since the cuts are too large for stitches. Problems that have been reported about this device include its failure to form correct staples, inability to fire properly and inserting staples that later come loose or fail to keep the incision closed. Injuries that may result from the use of a defective stapler include the following.
- Internal bleeding caused by the failure to close the wound or from the staple site itself.
- The leakage of stomach acid from areas that reopen after the procedure.
- Infection of the staple site or of the incision.
- Hernia resulting from the failure of the stapler to perform as intended.
- Septic shock, which is an infection which reaches the bloodstream and travels to major organs.
- Injuries that require revision surgeries.
- Death, in the most severe cases.
Stapler Manufacturers Playing the Blame Game
Ethicon currently has a market share of 66% of all gastric bypass staplers sold while U.S Surgical controls the rest of the market. Rather than responding to reports of the adverse events related to gastric bypass stapler use by recalling their products or improving their designs, these manufacturers have chosen instead to allow surgeons to take the fall. Ethicon has repeatedly alleged that the equipment malfunctions are the result of human error, but it is becoming increasingly difficult to substantiate this claim when the devices, not the surgeons, have become the common denominator in nearly 10,000 incidents.
In recent years, victims and their families have successfully filed lawsuits against Ethicon for product liability, which states that the manufacturer of a product is responsible for any injuries that the product causes when used as intended. If you underwent a gastric bypass procedure and suffered injuries due to staples not forming correctly or failing to close your wound, you may be entitled to compensation for the cost of medical treatment required to correct the issue, for pain and suffering and for any other financial loss you have incurred as a result.
The Rosenfeld Injury Lawyers have access to all of the resources needed to represent your interests and ensure that you receive fair compensation for your injuries. By enlisting the assistance of experts in fields such as medicine and economics, we are able to properly argue and value your case in order to make certain that your expenses are covered both in the present and the future. Contact us today to schedule a free consultation with an attorney so that we may evaluate your case and begin our own investigation.
Following a thorough evaluation, our attorneys can best advise you on your legal options and how best to pursue your claim. If for any reason we are unable to secure compensation on your behalf, all of our resources and time will be free of charge and you will not owe us a thing.