Phasix Mesh

Description of Event or Problem

As per patient advocate: NI/NI/NI - The patient had a small bowel obstruction and underwent surgery which included creation of an ileostomy. ON (b)(6 )2021- The patient underwent an Ileostomy Reversal and Abd Wall Reconstruction procedure with implant of a XenMatrix AB Graft (device #1). Post implant the patient experienced wound healing issues, seromas, infections and was treated with wound care and antibiotics. ON (b)(6) 2022- The patient was diagnosed with a Ventral Hernia and underwent repair with implant of the Phasix Mesh (device #2). ON (b)(6) 2022 - The patient was diagnosed with an Incarcerated Incisional Hernia and underwent repair with the implant of a Soft Mesh (device #3). As reported, the patient has not had any of the meshes removed. As reported, patient experienced multiple post operative complications including wound healing issues and chronic abdominal pain. Patient has had multiple epidural injections and had a pain stimulator with no relief. Reportedly, the patient is currently experiencing "inflammation in her gut and swelling in her left leg." Patient has seen at least 4 different gastroenterologists for her gastrointestinal issues, had been diagnosed with a pancreas and kidney cysts which continue to be monitored. The patient has been referred to an allergist for evaluation and possible reactivity testing. This file represents device #2 (Phasix Mesh).

Additional Manufacturer Narrative

Based on the information provided, no determination can be made regarding the degree to which the Phasix Mesh implant used to treat the patient may have caused or contributed to the patient's postoperative course. The Adverse Reactions section of the Instructions for Use (IFU) supplied with the device identifies pain and recurrence as known potential complications associated with use of the product. A review of the manufacturing records was conducted and confirmed that the product was manufactured in accordance with established specifications. To date, this is the only reported complaint associated with this manufacturing lot of 119 units distributed. Note, the date of event (25-Feb-2022) is considered to be a best estimate. This MDR represents the Phasix Mesh (device #2). Additional MDRs were submitted to represent the XenMatrix AB (device #1) and Soft Mesh (device #3). Note: Section A through F - The information provided by BD represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to BD.