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.
MARCH 2017 UPDATE:
Our firm has a long history of successfully representing patients with polypropylene mesh related injuries. For nearly a decade, we have represented thousands of women with transvaginal mesh related injuries including incurable, severe pelvic pain caused by acute and chronic inflammation and foreign body response. Medical literature, testimony from both treating and expert surgeons, doctor testimony have confirmed that the excessive inflammation and resulting tissue contraction, mesh erosion, infection and other complications were caused by defective design characteristics of transvaginal mesh. Among these design flaws, it has been argued that the mesh was not lightweight nor porous enough to allow for timely and healthy tissue incorporation into the host tissues of women’s pelvic floors and surrounding tissues. The manufacturers of transvaginal mesh, of note, directed the medical industry and the FDA to the prior clearance for sale of hernia mesh in its bid to bring mesh to market for vaginal indications. These manufacturers relied on alleged similarities with hernia mesh, without performing any clinical trials to examine and test safety and efficacy. Manufacturers prevailed, leading to one of the largest products liability cases in history. Today, much of the transvaginally placed mesh is no longer sold. Unfortunately, we believe that many of the design flaws that were revealed in the transvaginal mesh litigation are incorporated into hernia mesh sold today. Irrespective of the intense scrutiny placed upon their past practices, we believe that accumulated evidence gained during our investigations will show that these companies made many of the same mistakes and have failed to take timely corrective action. We further believe that these manufacturers, including Atrium (now known as Getinge Maquet), Ethicon, Covidien and Bard, rushed products to market in an attempt to compete in the competitive marketplace of hernia mesh.
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 defective products.
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. The Pensacola personal injury attorneys of Aylstock, Witkin Kreis & Overholtz handle national litigation across the United States for victims injured by defective pharmaceuticals and medical devices. Contact Aylstock, Witkin, Kreis & Overholtz today at (844) 794-7402 to get additional information regarding your rights as a Bard Kugel Hernia Patch injury victim.