Defective Medical Devices
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Health Risks
A defective medical device poses a serious health risk to people requiring its use. Millions of people use a variety of medical devices under the belief that they are safeguarded from a serious health risk. Medical device defects leave patients at serious risk of incurring a debilitating injury or even death if the issue goes undetected.
A medical device is an instrument designed to aid in the diagnosis and/or treatment of health-related issues. When functioning properly, medical devices have the potential to vastly improve the lives of people suffering from chronic diseases, illness or health-related abnormalities. As the technology incorporated in the design of medical devices continues to improve, so too does the potential with which said devices may aid in the diagnosis and treatment of many health-related issues.
Medical Device Approval
In order for medical devices to be marketed to the general public, they must first be approved by a division of the Food and Drug Administration (FDA) known as the Center for Devices and Radiological Health (CDRH). The CDRH has the responsibility of testing and approving each and every medical device to ensure that it is both safe and effective.
The CDRH often discovers medical device defects that prevent approval. If medical device defects are found to be widespread, the FDA may request a voluntary manufacturer recall or issue one itself if the manufacturer refuses to comply. In addition to potentially causing death, defective medical devices may also cause patients to experience a great deal of pain and suffering.
Bard Kugel Hernia Patch FDA Recall
The Bard Kugel Hernia Patch was hit with an FDA recall on December 22nd, 2005 after a troublesome pattern surfaced with regards to a defective "memory recoil ring" within the device. It was determined that a manufacturing defect affecting this ring could potentially lead to rupture, causing bowel perforations and / or chronic intestinal fistulae. Symptoms associated with ring breakage may include chronic abdominal pain, prolonged fever, or tenderness at the implant site.
This initial recall involved devices with lot numbers containing the letter M, N, O, or P as the fourth character. A second FDA hernia patch recall was issued in March of 2006 for Kugel Oval, Large Oval and Large Circle hernia patches. This second recall was also related to the potential rupture of the "memory recoil ring," though this was specifically related to the size of the implant rather than the manner in which it was implanted.
The FDA suggested that hospitals immediately suspend use of all affected Bard Kugel Hernia Patches. Affected patches should be returned to Davol Inc. for examination to help determine the extent of the defect. In cooperation with the FDA recall, Davol, Inc. contacted its patients on December 27th, 2005 warning them of the possible defect and alerting them to the hernia patch recall. Patients implanted with an affected hernia device were advised to seek medical attention immediately to determine the best course of action.
Bard Kugel Hernia Patch
The Bard Kugel Hernia Patch is a medical product that was designed and manufactured by Davol, Inc., a division of the C.R. Bard Corporation. It is constructed from a double layer of monofilament polypropylene and its placement aids in the prevention of new hernias at the three potential sites.
The implant's patented "memory recoil ring" is designed to allow the hernia patch to spring open after insertion while also maintaining its shape throughout the procedure. The Bard Kugel Hernia Patch serves as a reparative device for existing hernias while also serving as a preventative device, minimizing the potential for new hernia formation. The surgical procedure through which the Bard Kugel Hernia Patch is implanted is minimally invasive and can be performed under local or regional anesthesia.
Bard Kugel Hernia Patch Lawsuits
Since the initial hernia patch recall was issued in December of 2005, there have been approximately 24 reported instances of "memory recoil ring" defects. It is the responsibility of medical device manufacturers and parent companies to ensure that their products are safe before marketing them to the general public. Failure to do so is deemed negligent and grounds for litigation. Those who are injured as a result of a product defect may be eligible to receive personal injury compensation from any negligent parties. Contact us today at (850) 916 7450 to get additional information regarding your rights as a Bard Kugel Hernia Patch injury victim.
A Brief Introduction to Davol, Inc.
The Bard Kugel Hernia Patch is produced by Davol, Inc., a leader in the medical product industry. Davol, Inc. was founded in 1874, and in 1980 became a part of the C.R. Bard Corporation. In addition to the development and production of the Kugel Hernia Patch, Davol, Inc. has manufactured a number of innovative products that are used throughout a variety of medical specialties. The Davol, Inc. brand has been associated with the development of high quality products since the company's inception; however, such a long-standing history of excellence has no bearing on the liabilities faced by the company with regards to injuries caused by device malfunctions.