LifeCell Tissue Matrices: new alternatives for soft-tissue repair
There are many reasons patients may need an operation to repair weak or damaged tissue. Hernia surgery, breast reconstruction after mastectomy, revision procedures after breast augmentation surgery, and other diseases and degenerative conditions can all require tissue repair.
To help reduce the risk of potential problems in repairing or replacing weak or damaged tissue, your surgeon may choose to use an alternative: AlloDerm® Regenerative Tissue Matrix or Strattice™ Reconstructive Tissue Matrix from LifeCell. AlloDerm® Tissue Matrix and Strattice™ Tissue Matrix support regeneration (growth of new tissue) and they actually become part of your own body.
Every patient is different and results may vary. Only a physician can determine the best treatment for you. Please ask your doctor to explain the benefits and risks to see if LifeCell products are right for you.
From the manufacturer:
AlloDerm® Regenerative Tissue Matrix provides a strong, intact repair for challenging hernia repair and breast reconstruction postmastectomy procedures. Unlike other acellular human dermis products, AlloDerm® Tissue Matrix is produced through a unique non-damaging process that allows the body to mount its own tissue regeneration process.
Donated human skin tissue supplied by US AATB-compliant tissue banks is aseptically processed using LifeCell’s proprietary technique to remove the epidermis and cells that can lead to tissue rejection and graft failure. The result is an intact acellular matrix of natural biological components that promotes rapid revascularization, white cell migration and cell repopulation.
AlloDerm® Tissue Matrix provides excellent handling properties, exhibits a remarkable versatility to convert into functional tissues that provide structural support (e.g., gingiva and fascia), and is screened and tested according to FDA regulations, AATB standards and appropriate state regulations.
Used in challenging hernia and abdominal wall repair and breast reconstruction postmastectomy procedures, AlloDerm® Tissue Matrix transforms into host tissue for a natural repair and a safe and clinically optimal outcome. Its benefits include:
Abdominal wall reconstruction
Breast reconstruction postmastectomy
LifeCell Corporation Instructions for use:
http://www.lifecell.com/downloads/LC_Alloderm114_IFU_B_T4.pdf
Please review all information with your doctor to see if this is an option for you.
Maude Adverse Event Data on AlloDerm:
MAUDE Adverse Event Report
Results for 'AlloDerm® Regenerative Tissue Matrix' in All of FDA
... LIFECELL CORPORATION ALLODERM REGENERATIVE TISSUE MATRIX MESH, Back to Search Results.
Event Date 04/04/2008. ... Brand Name, ALLODERM REGENERATIVE TISSUE MATRIX. ...
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1045000 - 23k - Cached
Enforcement Report for April 16, 2008
... Recall # B-0911-08; d) AlloDerm, Oral Plastic ... B-0912-08; e) Graftjacket Regenerative
Tissue Matrix 5x5cm, .89 ... B-0913-08; f) Repliform Tissue Regeneration Matrix ...
www.fda.gov/Safety/Recalls/EnforcementReports/2008/ucm120502.htm - 67k - Cached
MedSun Reports
... Manufacturer response for Regenerative Tissue Matrix, AlloDerm
===== LifeCell was notified and will reveiw. ...
www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?id=%25%22-_%3E%25_%3C%20%0A - 16k - Cached
TPLC - Total Product Life Cycle
... Injury, 1. MDR Distribution by Brand. STRATTICE, 15. ALLODERM, 1. ALLODERM REGENERATIVE
TISSUE MATRIX, 1. ALLODERM TISSUE, 1. LTM, 1. Device Problems. Device emits ...
www.accessdata.fda.gov/.../cfdocs/cftplc/tplc.cfm?id=FTL&min_report_year=2007&long_name=LIFECELL%20CORP. - 20k - Cached
MedSun Reports
... Device brand name: Straight Plate Self Drilling Screws AlloDerm Regenerative
Tissue Matrix. Device manufacturer's name: Medtronic ...
www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?id=%25%22-_%3C%26_%5C%20%0A - 16k - Cached
MedSun Reports
... Device brand name: Straight Plate Self Drilling Screws AlloDerm Regenerative
Tissue Matrix. Device manufacturer's name: Medtronic ...
www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?ID=%25%22-_%3C%26_%5C%20%0A - 16k - Cached
Medsun: Newsletter #36, May 2009
... LifeCell Corporation, AlloDerm Regenerative Tissue Matrix Other: 402025, Patient
underwent resection of pilocytic astrocytoma in the posterior fossa. ...
www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/printer.cfm?id=994 - 19k - Cached
MedSun: Newsletter #36, May 2009
... LifeCell Corporation, AlloDerm Regenerative Tissue Matrix Other: 402025, Patient
underwent resection of pilocytic astrocytoma in the posterior fossa. ...
www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newsletter.cfm?news=36 - 91k - Cached
Enforcement Report for June 18, 2008
... PRODUCT Human Cornea Tissues, Recall # B ... Tissue Matrix, 2x4 cm, .33-76 mm; AlloDerm
GBR; 2x2 cm, .46-86 mm; Graft Jacket, Regenerative Tissue Matrix Ulcer Repair ...
www.fda.gov/Safety/Recalls/EnforcementReports/2008/ucm120511.htm - 193k - 2009-05-28 - Cached
There are many reasons patients may need an operation to repair weak or damaged tissue. Hernia surgery, breast reconstruction after mastectomy, revision procedures after breast augmentation surgery, and other diseases and degenerative conditions can all require tissue repair.
To help reduce the risk of potential problems in repairing or replacing weak or damaged tissue, your surgeon may choose to use an alternative: AlloDerm® Regenerative Tissue Matrix or Strattice™ Reconstructive Tissue Matrix from LifeCell. AlloDerm® Tissue Matrix and Strattice™ Tissue Matrix support regeneration (growth of new tissue) and they actually become part of your own body.
Every patient is different and results may vary. Only a physician can determine the best treatment for you. Please ask your doctor to explain the benefits and risks to see if LifeCell products are right for you.
From the manufacturer:
AlloDerm® Regenerative Tissue Matrix provides a strong, intact repair for challenging hernia repair and breast reconstruction postmastectomy procedures. Unlike other acellular human dermis products, AlloDerm® Tissue Matrix is produced through a unique non-damaging process that allows the body to mount its own tissue regeneration process.
Donated human skin tissue supplied by US AATB-compliant tissue banks is aseptically processed using LifeCell’s proprietary technique to remove the epidermis and cells that can lead to tissue rejection and graft failure. The result is an intact acellular matrix of natural biological components that promotes rapid revascularization, white cell migration and cell repopulation.
AlloDerm® Tissue Matrix provides excellent handling properties, exhibits a remarkable versatility to convert into functional tissues that provide structural support (e.g., gingiva and fascia), and is screened and tested according to FDA regulations, AATB standards and appropriate state regulations.
Used in challenging hernia and abdominal wall repair and breast reconstruction postmastectomy procedures, AlloDerm® Tissue Matrix transforms into host tissue for a natural repair and a safe and clinically optimal outcome. Its benefits include:
Abdominal wall reconstruction
Breast reconstruction postmastectomy
LifeCell Corporation Instructions for use:
http://www.lifecell.com/downloads/LC_Alloderm114_IFU_B_T4.pdf
Please review all information with your doctor to see if this is an option for you.
Maude Adverse Event Data on AlloDerm:
MAUDE Adverse Event Report
Results for 'AlloDerm® Regenerative Tissue Matrix' in All of FDA
... LIFECELL CORPORATION ALLODERM REGENERATIVE TISSUE MATRIX MESH, Back to Search Results.
Event Date 04/04/2008. ... Brand Name, ALLODERM REGENERATIVE TISSUE MATRIX. ...
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1045000 - 23k - Cached
Enforcement Report for April 16, 2008
... Recall # B-0911-08; d) AlloDerm, Oral Plastic ... B-0912-08; e) Graftjacket Regenerative
Tissue Matrix 5x5cm, .89 ... B-0913-08; f) Repliform Tissue Regeneration Matrix ...
www.fda.gov/Safety/Recalls/EnforcementReports/2008/ucm120502.htm - 67k - Cached
MedSun Reports
... Manufacturer response for Regenerative Tissue Matrix, AlloDerm
===== LifeCell was notified and will reveiw. ...
www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?id=%25%22-_%3E%25_%3C%20%0A - 16k - Cached
TPLC - Total Product Life Cycle
... Injury, 1. MDR Distribution by Brand. STRATTICE, 15. ALLODERM, 1. ALLODERM REGENERATIVE
TISSUE MATRIX, 1. ALLODERM TISSUE, 1. LTM, 1. Device Problems. Device emits ...
www.accessdata.fda.gov/.../cfdocs/cftplc/tplc.cfm?id=FTL&min_report_year=2007&long_name=LIFECELL%20CORP. - 20k - Cached
MedSun Reports
... Device brand name: Straight Plate Self Drilling Screws AlloDerm Regenerative
Tissue Matrix. Device manufacturer's name: Medtronic ...
www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?id=%25%22-_%3C%26_%5C%20%0A - 16k - Cached
MedSun Reports
... Device brand name: Straight Plate Self Drilling Screws AlloDerm Regenerative
Tissue Matrix. Device manufacturer's name: Medtronic ...
www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?ID=%25%22-_%3C%26_%5C%20%0A - 16k - Cached
Medsun: Newsletter #36, May 2009
... LifeCell Corporation, AlloDerm Regenerative Tissue Matrix Other: 402025, Patient
underwent resection of pilocytic astrocytoma in the posterior fossa. ...
www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/printer.cfm?id=994 - 19k - Cached
MedSun: Newsletter #36, May 2009
... LifeCell Corporation, AlloDerm Regenerative Tissue Matrix Other: 402025, Patient
underwent resection of pilocytic astrocytoma in the posterior fossa. ...
www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newsletter.cfm?news=36 - 91k - Cached
Enforcement Report for June 18, 2008
... PRODUCT Human Cornea Tissues, Recall # B ... Tissue Matrix, 2x4 cm, .33-76 mm; AlloDerm
GBR; 2x2 cm, .46-86 mm; Graft Jacket, Regenerative Tissue Matrix Ulcer Repair ...
www.fda.gov/Safety/Recalls/EnforcementReports/2008/ucm120511.htm - 193k - 2009-05-28 - Cached
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