Table 3.
Summary of High-risk (Class III) Plastic Surgery Devices
| PMA Number | Manufacturer | Device | Approval Year | Product Codes | Type of Device | No. Supplements | FDA Recall Class (Posting Date) | Withdrawal Date | Device-years |
|---|---|---|---|---|---|---|---|---|---|
| P800022 | Allergan | Zyderm collagen implant(Zyderm CI) | 1981 | LMH | Dermal implant | 35 | 10/25/2011 | 30 | |
| P850053 | Mentor Corp. | Fibrel | 1988 | LMH | Dermal implant | 4 | 02/28/2008 | 20 | |
| P870069 | UDL Laboratories, Inc. | Biobrane(R) II | 1989 | FRO | Wound device | 1 | 01/19/2010 | 21 | |
| P890002 | Alcon Laboratories | Polypropylene Surgical Suture | 1989 | GAW | Suture | 0 | 29 | ||
| P900033 | Integra LifeSciences Corp. | Integra Dermal Regeneration Template | 1996 | MGR | Wound device | 64 | 2(2009) 3(2008) | 22 | |
| P960007 | Shire Regenerative Medicine | Transcyte Human Fibroblast-Derived Temporary Skin Substitute | 1997 | MGR | Wound device | 12 | 21 | ||
| P950032 | Organogenesis, Inc. | Apligraf (Graftskin) | 1998 | MGR | Wound device | 63 | 2(2011) 2(2011) 2(2010) 2(2009) 2(2008) 3(2006) | 20 | |
| P990004 | Ferrosan Medical Devices A/S | Surgifoam Absorbable Gelatin Sponge, USP | 1999 | LMF | Hemostasis adjunct | 0 | 1(2012) 1(2012) 2(2012) | 19 | |
| P990019 | Dusa Pharmaceuticals, Inc. | Blu -U Blue Light Photodynamic Therapy Illuminator | 1999 | MVF | Laser | 5 | 19 | ||
| P990021 | Concordia Laboratories, Inc | Diomed 630 PDT Laser | 2000 | MVF | Laser | 3 | 18 | ||
| P990049 | Lumenis | Coherent Opal Photoactivator Laser System | 2000 | MVF | Laser | 1 | 09/10/2010 | 10 | |
| P990074 | Allergan | Natrelle Saline Breast Implants | 2000 | FWM | Breast implant | 34 | 3(2005) 3(2005) | 18 | |
| P990075 | Mentor Worldwide LLC | Mentor Corporation Saline-Filled And Spectrum (R) Mammary Prostheses | 2000 | FWM | Breast implant | 41 | 2(2017) | 18 | |
| P000036 | Shire Regenerative Medicine | Dermagraft | 2001 | MGR | Wound device | 13 | 2(2003) | 17 | |
| P010016 | Forticell Bioscience | Orcel Bilayered Cellular Matrix | 2001 | MGR | Wound device | 2 | 17 | ||
| P020023 | Q-Med AB | Restylane Injectable Gel | 2003 | LMH | Dermal implant | 12 | 15 | ||
| P060028 | Mentor Worldwide LLC | Mentor Memoryshape Breast Implants | 2003 | FTR | Breast implant | 24 | 15 | ||
| P010061 | Photo Cure Asa | Curelight Broadband (Model Curelight 01) | 2004 | MYH | Laser | 0 | 08/28/2008 | 4 | |
| P030032 | Genzyme Biosurgery | Hylaform (Hylan B Gel) | 2004 | LMH | Dermal implant | 12 | 02/10/2016 | 12 | |
| P030050 | Q-Med AB | Sculptra And Sculptra Aesthetic | 2004 | LMH | Dermal implant | 19 | 14 | ||
| P040024 | Q-Med AB | Restylane Injectable Gel | 2005 | LMH | Dermal implant | 92 | 13 | ||
| P020012 | Suneva Medical, Inc. | Artefill, Bellafill PMMA Collagen Permanent Dermal Filler | 2006 | LMH | Dermal implant | 15 | 12 | ||
| P020056 | Allergan | Natrelle Silicone-Filled Breast Implants | 2006 | FTR | Breast implant | 33 | 12 | ||
| P030053 | Mentor Corp. | Memorygel Silicone Gel-Filled Breast Implants | 2006 | FTR | Breast implant | 31 | 2(2016) | 12 | |
| P050033 | Anika Therapeutics, Inc. | Hydrelle | 2006 | LMH | Dermal implant | 17 | 12 | ||
| P050037 | Merz North America, Inc | Radiesse 1.3CC And 0.3CC | 2006 | LMH | Dermal implant | 85 | 2(2011) 3(2011) | 12 | |
| P050047 | Allergan | Juvederm 24HV, Juvederm 30 And Juvederm 30HV Gel Implants | 2006 | LMH | Dermal implant | 61 | 12 | ||
| P050052 | Merz North America, Inc | Radiesse Injectable Implant | 2006 | LMH | Dermal implant | 93 | 2(2016) 2(2015) 2(2011) 3(2011) | 12 | |
| P070013 | Colbar Lifescience Ltd. | Evolence Collagen Filler | 2008 | LMH | Dermal implant | 3 | 12/03/2010 | 2 | |
| P060029 | Ethicon, Inc. | Ethicon Omnex Surgical Sealant | 2010 | NBE | Vascular reconstruction adhesive | 3 | 8 | ||
| P090016 | Merz North America, Inc | Belotero Balance | 2011 | LMH | Dermal implant | 23 | 7 | ||
| P070004 | Sientra, Inc | Sientra Silicone Gel Breast Implants | 2012 | FTR | Breast implant | 8 | 6 | ||
| P120011 | Idealimplant | Ideal Implant Saline-Filled Breast Implant | 2012 | FWM | Breast implant | 12 | 6 | ||
| P040046 | Allergan | Natrelle Highly Cohesive Silicone-Filled Breast Implants | 2013 | FTR | Breast implant | 23 | 5 | ||
| P110033 | Allergan | Juvederm Voluma XC | 2013 | LMH | Dermal implant | 37 | 5 | ||
| P140029 | Q-Med AB | Restylane Refyne, Restylane Defyne | 2016 | LMH | Dermal implant | 12 | 2 | ||
| P150046 | Scibase AB | Nevisense | 2017 | ONV | Electrical impedance spectrometer | 2 | 1 | ||
| P160042 | Prollenium Medical Technologies Inc. | Revanesse Ultra | 2017 | LMH | Dermal implant | 2 | 1 | ||
| P170002 | Teoxane S.A. | RHA 2, RHA 3, RHA 4 | 2017 | LMH | Dermal implant | 0 | 1 |