The Kugel Mesh Hernia Patch injury lawyers at our firm are working hard to make sure that victims of the defective Bard Composix Kugel Mesh Hernia Patch receive just compensation for their injuries. The poor design of the Kugel Mesh Hernia Patch has resulted in painful and sometimes life threatening injuries, including bowel perforations, chronic enteric fistulas and infections, in thousands of recipients. In most instances, the injuries caused by the Kugel Mesh Hernia Patch have required patients to undergo even more painful surgeries. Even with surgical intervention, many victims of the Kugel Mesh Hernia Patch will not completely recover from their injuries. Our Kugel Mesh Hernia Patch lawyers are dedicated to making sure that the makers of the Kugel Mesh Hernia Patch are held accountable for these serious injuries.
The Kugel Mesh Hernia Patch was implanted in thousands of patients before Davol finally removed the defective device from the market. Thousands of people still live with the Kugel Mesh Hernia Patch, and the device could fail at any time. Patients with any type of hernia patch – but especially those with a Kugel Mesh Hernia Patch – should seek medical help if they experience unexplained fever, persistent abdominal pain or tenderness at the incision site. These could be a sign that the recoil ring has broken, and only immediate attention can prevent more serious health consequences. Because of the continuing danger posed by the Kugel Mesh Hernia Patch, our medical device lawyers will continue aiding victims of the Kugel Mesh Hernia Patch as long as a need exists.
Our Kugel Mesh Hernia Patch injury lawyers are also offering free consultations to anyone who received other Davol hernia patches and suffered injuries or infections as a result of patch failure. In January 2008, the Federal Court charged with hearing all claims related to the Kugel Mesh Hernia Patch ruled the proceedings would be expanded to include claims against any of Davol Inc’s defective mesh patches, even those that were not involved in the original Kugel Mesh Hernia Patch recall. Our Kugel Mesh Hernia Patch lawsuit lawyers want to hear from anyone who sustained a serious injury as a result of any Davol-manufactured mesh hernia patch.
Kugel Mesh Hernia Patch Recall
The Bard Composix Kugel Mesh Hernia Patch has been the subject of several Food & Drug Administration (FDA) Class I recalls. The FDA only issues a Class I recall when a device poses a serious risk to patients still using it. Our Kugel Mesh Hernia Patch injury lawyers have determined that Davol Inc. and its parent, C.R. Bard, were too slow in issuing the Kugel Mesh Hernia Patch recalls, and needlessly exposed thousands of patients to serious injuries.
The first Bard Composix Kugel Mesh Hernia Patch recall was issued in December 2005. At that time, the company recalled its Bard Composix Kugel Mesh X-Large Patch. At that time, the FDA also warned patients who received the Kugel Mesh Hernia Patch to seek medical attention if they experienced unexplained fever, persistent abdominal pain, or tenderness to the incision site. In April 2006, the Kugel Mesh Hernia Patch Class I recall was expanded to the mid-line sizes of the patch. The Kugel Mesh Hernia Patch recall was expanded for a third time in February of 2007 to include the large size patch.
Unfortunately, the thousands of patients who received the Kugel Mesh Hernia Patch were left with few alternatives, other than to wait to see if their patches malfunctioned. Many of these patients received the Kugel Mesh Hernia Patch long after Davol received the first reports of Kugel Mesh Hernia Patch failure. The Kugel Mesh Hernia Patch lawyers at our firm believe that many patients could have been saved from both serious injuries and anxiety if Davol had moved more quickly to deal the patch safety issues.
Kugel Hernia Patch Problems Ignored by Davol
Davol had received its first Kugel Mesh Hernia Patch complaints in 2002. All of the complaints revolved around the Kugel Mesh Hernia Patch recoil ring. The Kugel Mesh Hernia Patch is constructed with a spring-like recoil ring that opens the Kugel Mesh Hernia Patch after insertion. The recoil ring design was supposed to reduce the incidences of re-tears, but as our Kugel Mesh Hernia Patch injury lawyers have discovered during their investigation, the recoil ring was defective and has caused serious and painful injuries to many Kugel Mesh Hernia Patch patients.
Davol did nothing when it started receiving reports of recoil ring failures causing serious injuries in patients who received the X-large Kugel Mesh Hernia Patch. Davol claims that the “few” number of Kugel Mesh Hernia Patch injury reports did not warrant public notification. But in 2005, Davol received 10 reports about recoil ring breakage over a three month period. Still, Davol did not take responsibility for its defective device and blamed doctors for implanting the device improperly. All Davol did was to start work on new instructions for implanting the Kugel Mesh Hernia Patch, and offer training session for some physicians. But the Kugel Mesh Hernia Patch remained on the market.
It wasn’t until 2005 that Davol quit denying that the Kugel Mesh Hernia Patch was defective. In December, Davol ran tests and discovered that the source of the Kugel Mesh Hernia Patch problems was not doctor error, but failure of the ring weld on the device itself. It was then that Davol decided to issue a recall of the X-Large Kugel Mesh Hernia Patch, but by then this dangerous device had been implanted in thousands of unsuspecting patients. The Kugel Mesh Hernia Patch lawyers at our firm have seen the results of Davol’s negligence, and we know how devastating injuries from the Kugel Mesh Hernia patch can be. We have committed ourselves to insuring that the victims of the Kugel Mesh Hernia Patch receive the justice they deserve.
Davol Inc. FDA Warning Letter
The FDA undertook an inspection of the Davol company headquarters in Cranston, Rhode Island in early 2007, following the Kugel Mesh Hernia Patch recall. That inspection resulted in the FDA issuing a scathing warning letter to Davol. The FDA issues warning letters when an inspection finds serious problems in the methods, facilities and controls used in the manufacture, storage, packing or installation of a company’s products.
The warning letter, dated April 24, 2007, states that the Davol facility lacked procedures to handle everything from complaint investigation to the determination of actual recall actions. The FDA said that the lack of these procedures where directly to blame for Davol’s delays in dealing with the Kugel Mesh Hernia Patch’s problems. The Kugel Mesh Hernia Patch injury lawyers at our firm consider this April 2007 FDA warning letter yet another example of Davol’s negligence in regards to the Kugel Mesh Hernia Patch.
Need Legal Help Regarding Composix Kugel Patch?
If you or a loved one were injured by a Kugel Mesh Hernia Patch, or any of Davol Inc.’s other defective mesh hernia patches, you have valuable legal rights. Please fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529) for a free consultation with a Kugel Mesh Hernia Patch lawyer.