FDA Surveillance Studies of Urogynecologic Surgical Mesh

On January 3, 2012, the FDA ordered postmarket surveillance studies, known as “522 Studies,” (Guidance for Industry and FDA Staff Postmarket Surveillance Under Section 522 of the Federal Food, Drug and Cosmetic Act) of urogynecologic surgical mesh.

Altogether, 99 studies were ordered, including 88 postmarket study orders from 33 manufacturers of urogynecologic surgical mesh for pelvic organ prolapse; and 11 postmarket study orders to seven manufacturers of single-incision mini-slings for stress urinary incontience.

The goal of these studies is to “provide the FDA, manufacturers, and health care providers with data that can inform the FDA’s understanding of the safety and effectiveness profile of urogynecologic surgical mesh.” [source]

Surgical Mesh: 522 Studies Requested by the FDA
522 Application Number Applicant Name Device Name
PS120001 Acell Inc Acell ubm surgical mesh ml and mlplus
PS120002 American Medical Systems Inc. Ams large pore polypropylene mesh
PS120003 American Medical Systems Inc. Ams large pore polypropylene mesh
PS120004 American Medical Systems Inc. Ams elevate anterior & apical prolapse repair system with intepro lite
PS120005 American Medical Systems Inc. Ams elevate anterior & apical prolapse repair system with intepro lite
PS120006 American Medical Systems Inc. Ams elevate apical and posterior prolapse repair system with intepro lite or intexen lp
PS120007 American Medical Systems Inc. Ams elevate apical and posterior prolapse repair system with intepro lite or intexen lp
PS120008 American Medical Systems Inc. Ams elevate apical and posterior prolapse repair system with intepro lite or intexen lp
PS120009 American Medical Systems Inc. Apogee and perigee systems with intepro lite and intexen lp part of the ams pelvic floor repair system; Ams collagen dermal matrix ams apogee system with pre-connected collagen dermal matrix ams perigee system with pre-connected collagen dermal matrix
PS120010 American Medical Systems Inc. Apogee and perigee systems with intepro lite and intexen lp part of the ams pelvic floor repair system; Ams collagen dermal matrix ams apogee system with pre-connected collagen dermal matrix ams perigee system with pre-connected collagen dermal matrix
PS120011 American Medical Systems Inc. Apogee and perigee systems with intepro lite and intexen lp part of the ams pelvic floor repair system; Ams collagen dermal matrix ams apogee system with pre-connected collagen dermal matrix ams perigee system with pre-connected collagen dermal matrix
PS120012 American Medical Systems Inc. Apogee and perigee systems with intepro lite and intexen lp part of the ams pelvic floor repair system; Ams collagen dermal matrix ams apogee system with pre-connected collagen dermal matrix ams perigee system with pre-connected collagen dermal matrix
PS120013 American Medical Systems Inc. Apogee and perigee systems with pc coated intepro lite
PS120014 American Medical Systems Inc. Elevate prolapse repair system with pc coated intepro lite- apical and posterior prolapse repair system anterior and ap
PS120015 American Medical Systems Inc. Ams collagen dermal matrix ams apogee system with pre-connected collagen dermal matrix ams perigee system with pre-connected collagen dermal matrix
PS120089 American Medical Systems Inc. Miniarc precise single-incision sling system
PS120090 American Medical Systems Inc. Miniarc precise single-incision sling system
PS120091 American Medical Systems Inc. Miniarc precise single-incision sling system
PS120092 American Medical Systems Inc. Miniarc precise single-incision sling system
PS120016 BioVascular Inc. Peri-guard cv peri-guard ocu-guard supple peri-guard peri-strips – sleeve peri-strips-strips peri-strips dry vasc
PS120018 BioVascular Inc. Supple peri-guard pericardium
PS120019 BioVascular Inc. Supple peri-guard pericardium
PS120020 BioVascular Inc. Supple peri-guard pericardium
PS120021 Boston Scientific Corporation Lite pelvic floor repair kits
PS120022 Boston Scientific Corporation Pelvic floor repair system (pinnacle duet)
PS120023 Boston Scientific Corporation Pinnacle pelvic floor repair kit ii (uphold)
PS120024 Boston Scientific Corporation Pinnacle pelvic floor repair kits (pinnacle)
PS120093 Boston Scientific Corporation Boston scientific surgical mesh (solyx sis)
PS120025 Brennen Medical Inc. BRENNEN MEDICAL SURGICAL MESH GLUCAMESH/GLUCATEX
PS120026 Brennen Medical Inc. DERMMATRIX SURGICAL MESH
PS120027 C.R. Bard Inc. Avaulta solo synthetic support system avaulta plus biosynthetic support system; Avaulta support system
PS120028 C.R. Bard Inc. Avaulta solo synthetic support system avaulta plus biosynthetic support system; Avaulta support system
PS120029 C.R. Bard Inc. Avaulta solo synthetic support system avaulta plus biosynthetic support system; Avaulta support system
PS120030 C.R. Bard Inc. Bard prolapse repair system
PS120031 C.R. Bard Inc. Bard pelvisoft acellular collagen biomesh
PS120094 C.R. Bard Inc. Ajust adjustable single incision sling
PS120032 Caldera Medical Inc. POPMESH
PS120033 Caldera Medical Inc. ASCEND BLUE AC MESH; ASCEND BLUE PC MESH
PS120034 Caldera Medical Inc. ASCEND BLUE AC MESH; ASCEND BLUE PC MESH
PS120035 Coloplast Corp Exair anterior and posterior prolapse repair systems
PS120036 Coloplast Corp EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS
PS120037 Coloplast Corp MENTOR NOVASILK MESH
PS120038 Coloplast Corp RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH
PS120055 Coloplast Corp MINIMESH POLYPROPYLENE MESH
PS120056 Coloplast Corp MINIMESH POLYPROPYLENE MESH
PS120096 Coloplast Corp GYNE IDEAS MINITAPE RP DEVICE
PS120097 Coloplast Corp MINITAPE URETHRAL SLING
PS120098 Coloplast Corp MINITAPE URETHRAL SLING
PS120039 Cook Biotech Inc. Surgisis staple line reinforcement
PS120040 Cousin Biotech SARL BIOMESH P1 AND BIOMESH PLUG AND PATCH
PS120071 Covidien Parietene duo and quadra polypropylene meshes
PS120072 Covidien Ugytex dual knit mesh
PS120075 Covidien Permacol surgical implant t-piece permacol surgical implant rectocele-piece models 5928-150 5645-150
PS120076 Covidien Permacol surgical implant t-piece permacol surgical implant rectocele-piece models 5928-150 5645-150; Permacol surgical implant
PS120041 CryoLife Inc. PROPATCH SOFT TISSUE REPAIR MATRIX
PS120042 CryoLife Inc. Propatch soft tissue repair matrix
PS120095 Ethicon Inc. Gynecare tvt secur system
PS120043 Ethicon Inc. Gynecare prolift +m* pelvic floor repair systems
PS120044 Ethicon Inc. Gynecare prosima pelvic floor repair systems
PS120045 Ethicon Inc. Tbd ethicon mesh (gynecare gynemesh m)
PS120046 Ethicon Inc. Gynemesh prolene soft (polypropylene) nonabsorbable synthetic surgical mesh for pelvic floor repair
PS120053 Herniamesh SRL Pelvimesh / hermesh 7
PS120048 Kensey Nash Corporation BIOBLANKET SURGICAL MESH
PS120049 Kensey Nash Corporation BIOBLANKET SURGICAL MESH
PS120050 Kensey Nash Corporation MEDEOR MATRIX MODELS 30010-XX (HYDRATED); 30020-XX (DRY)
PS120051 Kensey Nash Corporation Kensey nash ecm surgical patch
PS120052 Macropore Biosurgery Inc. Macropore surgiwrap (ts)
PS120054 Mast Biosurgery USA Inc. Surgi-wrap mast bioresorbable sheet
PS120057 Neomedic International SURELIFT PROLAPSE SYSTEM
PS120058 Organogenesis Inc. FORTAFLEX SURGICAL MESH
PS120059 Organogenesis Inc. FORTAFLEX SURGICAL MESH
PS120060 Organogenesis Inc. FORTAFLEX SURGICAL MESH
PS120047 PFM Medical Timesh also known as timesh-tc models 6000001 & 6000004
PS120066 Promethean Surgical Devices Inc. HYDROCOAT MESH
PS120099 Prosurg Inc. MINISLING ADJUSTABLE POLYMER SLING & SURGICAL MESH WITH SELF-ANCHORING SYSTEM (EASY LIFT PROLAPSE REPAIR & MINISLING)
PS120067 Proxy Biomedical Ltd. POLYFORM SYNTHETIC MESH
PS120068 RTI Biologics Inc. Tutopatch tutomesh
PS120069 Shelhigh Inc. Shelhigh porcine pericardial patch
PS120070 Shelhigh Inc. SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH.
PS120062 Smith & Nephew Immix thin film models: Pss-004-s pss-004-sp pss-004-m pss-004-mp pss-004-l pss-004-lp
PS120061 Smith & Nephew Inc Immix plastifilm
PS120073 Sofradim Production Ugytex mesh
PS120074 Sofradim Production Parietex
PS120063 Synovis Surgical Innovation Orthadapt pr; Orthadapt bioimplant; Pegasus biologics orthadapt surgical mesh
PS120064 Synovis Surgical Innovation Orthadapt pr; Orthadapt bioimplant; Pegasus biologics orthadapt surgical mesh
PS120065 Synovis Surgical Innovations Orthadapt pr; Orthadapt bioimplant; Pegasus biologics orthadapt surgical mesh
PS120077 Synovis Surgical Innovations Veritas collagen matrix
PS120078 Synovis Surgical Innovations Veritas collagen matrix
PS120017 Synovis Surgical Innovations Peri-strips
PS120080 Tei Biosciences Inc. TISSUEMEND SOFT TISSUE REPAIR MATRIX
PS120081 Tei Biosciences Inc. XENFORM SOFT TISSUE REPAIR MATRIX
PS120082 Tei Biosciences Inc. Xenform soft tissue repair matrix
PS120079 Tepha Inc. Tephaflex surgical mesh
PS120083 W.L. Gore & Associates Inc. Seamguard staple line reinforcement material
PS120084 W.L. Gore & Associates Inc. Modification to seamguard staple line reinforcement material
PS120085 W.L. Gore & Associates Inc. Gore bioabsorbable mesh
PS120086 W.L. Gore & Associates Inc. Seamguard staple line reinforcement material
PS120087 Xylos Corporation Xylos porous surgical mesh
PS120088 Xylos Corporation Xylos porous surgical mesh

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