VCU DEATH AND COMPLICATIONS CONFERENCE

Brief Overview of Case  Diagnosis/Complication: Readmission with SBO following laparoscopic incisional hernia repair 11/17/11

Clinical History  49 y/o  PMH: asthma, depression, breast Ca PSH: cervial spinal fusion, lumbar spine fusion, BTL, segmental mastectomy (06/2010), lipectomy (2010), BSO/fundal myomectomy  11/17 – Lap incisional hernia repair with Proceed mesh  11/20 – ER abd pain – acute series with ileus  12/7 – 24 hours abd pain, N/V, CT-SBO

Analysis of Complication Was the complication potentially avoidable? – Yes, likely technical Would avoiding the complication change the outcome for the patient? – Yes – readmission, reoperation What factors contributed the complication? – Technical, pervious surgery

Evidence Based Literature ETHICON's PROCEED ® ETHICON's PROCEED ® Surgical Mesh- Multilayer tissue-separating mesh for open & laparoscopic incisional hernia repair. New PROCEED® Surgical Mesh features a thin, bioresorbable fabric layer that effectively separates its strong, supportive mesh from underlying viscera. A composite of proven products from ETHICON Products, PROCEED® Mesh can be placed both below the muscle layer and outside of the peritoneum or in the intra-abdominal cavity and offers the following benefits: Effectively seperates mesh from underlying viscera Does not harbor bacteria that can lead to infection Lightweight monofilament construction for patient comfort Properties: PROLENE Soft Mesh -Polypropylene encapsulated with polydioxanone (PDS) -Designed for strength, durability and adaptability Oxidized regenerated cellulose (ORC) fabric -Minimizes tissue attachment Absorbable polydioxanone(PDS) -Bonds the ORC to the mesh

The Proceed Surgical Mesh was hit with an FDA recall on December 21st, 2005 after a troublesome pattern surfaced with regards to a the soft mesh layer of the patch delaminating from the polypropylene layer, leaving it exposed. It was determined that this exposure to the polypropylene could lead to an increased risk of adhesions and bowl fistulization. Symptoms associated with these injuries may include chronic abdominal pain, prolonged fever, or tenderness at the implant site. The FDA suggested that hospitals immediately suspend use of all affected Proceed Surgical Meshes. In cooperation with the FDA recall, Ethicon, Inc. contacted its patients on January 4, 2006 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. The Proceed Surgical Mesh is a medical product that was designed and manufactured by Ethicon, Inc., a division of Johnson & Johnson Gateway, LLC. It is constructed from a layer of soft polypropylene and an oxidized regenerated cellulose and its placement aids in the prevention of new hernias at various potential sites. The construction of the Proceed mesh was specifically designed to minimize tissue attachment and provide flexible scar tissue. The Proceed Surgical Mesh 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 Proceed Surgical Mesh is implanted is minimally invasive and can be performed under local or regional anesthesia.