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Kugel Mesh Hernia Patch Recall
Since 2005, the FDA has issued three separate recalls on Kugel Mesh Hernia Patches produced by Davol, Inc. (a subsidiary of the Bard company). While initial hernia patch recalls were limited in scope, the latest recall in January 2007 was expanded to include six varieties of these patches.
With its final recall in 2007, the FDA also raised the recall status to the most serious "Class I" category, a distinction indicating that any patients still using Kugel Mesh Hernia Patches are at a high risk of developing potentially serious health complications.
Kugel Mesh Hernia Patch Defects
Used to treat ventral hernias, the Kugel Mesh Hernia Patch is a round, flat prosthetic made of two pieces of mesh with a bendable plastic ring (the "memory recoil ring") between them. The flexibility of the memory recoil ring allows surgeons to:
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- implant bent hernia patches through a small incision
- move them to the site of the hernia
- then release a bent ring so that the device recoils to its naturally flat position
All materials used in the Kugel Mesh Hernia Patch are safe for use in the human body. Consequently, these hernia patches can remain implanted throughout the recovery process, supporting weakened abdominal walls as tissues grow around and over the patches to heal hernia damage.
Despite these features, the Kugel Mesh Hernia Patch has a major defect: its plastic ring can break and damage surrounding organs. When a Kugel Mesh Hernia Patch defect occurs, patients can suffer from:
- bowel obstruction
- bowel perforation
- chronic intestinal fistulae (an unnatural connection between two parts of the intestines)
- infections
- sepsis
- death
To prevent serious health problems and possibly death, doctors (and the FDA) warn hernia patch patients to seek immediate medical care if they start experiencing any of the following symptoms, as these can indicate a Kugel Mesh Hernia Patch defect:
- abdominal pain
- bloating
- constipation
- diarrhea
- high, persisting fever
- nausea
- vomiting
Types of Kugel Mesh Hernia Patches RecalledThe following varieties of Kugel Mesh Hernia Patches have been recalled (The specific product code for each recalled unit is listed in the parentheses):· extra large oval, 8.7" x 10.7" (PC 0010206)· extra large oval, 20.8" x 13.7" (PC 0010207)· extra large oval, 7.7" x 9.7" (PC 0010208)· oval, 6.3" x 12.3" (PC 0010209)· large oval, 5.4" x 7.0" (PC 0010202)· large circle, 4.5" (PC 0010204)
The FDA Investigation: Davol's Negligence
After issuing a series of recalls on Davol's Kugel Mesh Hernia Patches, the FDA launched a complete investigation of Davol's facilities. During its inspection, the FDA found that Davol was in violation of certain regulations and was negligent in the following ways:
- Severe problems plagued the controls, processes and facilities used to make and store medical devices.
- The system used to collect and track patient complaints was seriously flawed.
- Davol lacked any process for managing complaint investigations and product recalls.
- For certain devices, Davol didn't perform proper testing to ensure that products met the company's own standards.
Although the FDA issued a series of warnings to Davol after this investigation, for many patients, the damage has already been done. As a result, patients affected by Davol's negligence and faulty devices have already started filing lawsuits, seeking compensation for injuries they have sustained after using Davol's products.
If you have been injured by a recalled Kugel Mesh Hernia Patch, let us evaluate your case and inform you of your legal options. We look forward to helping you.
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