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I looked through a few Bard mesh reports and they all look about the same. “Attorney says patient was harned by mesh”. Manufacturer says “No manufacturing lot number is present therefore no conclusion can be drawn”.
The manufacturer is saying that it must be a problem in the manufacturing process. Pretending that it is not a fundamental aspect of the product design. Makes no effort to find out what happened.
The FDA does nothing.
It is pretty depressing reading so be ready if you decide to browse a few. But it’s easy to see where the lawsuits are coming from.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=12479336&pc=FTL
“Manufacturer Narrative
No conclusions can be made. The patient’s attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient. The patient’s attorney alleges that the patient had subsequent surgical intervention; however, no details have been provided. No lot number has been provided; therefore, a review of the manufacturing records is not possible. This emdr represents the bard mesh (bard flat mesh) (device #1). An additional emdr was submitted to represent the bard/davol marlex mesh (bard flat mesh) (device #2). Should additional information be provided, a supplemental emdr will be submitted. Not returned.Event Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard mesh (bard flat mesh) and bard/davol marlex (bard flat mesh) on (b)(6) 2013. As reported, the patient is making a claim for an adverse patient outcome against both devices. Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device. It is also alleged that the patient experienced emotional distress, sustained personal injury and the device was defective.”