Summary of MedSun Reports Describing Adverse Events With Breast Tissue Expanders
MedSun: Newsletter #42, November 2009
A tissue expander is a device intended for temporary (less than 6 months) subdermal implantation to stretch the skin for surgical applications, specifically to develop surgical flaps and additional tissue coverage. It is made of an inflatable silicone elastomer shell filled with Normal Physiological Saline (injection grade).
Breast tissue expanders are placed, at the time of mastectomy, to stretch the skin and create a pocket for a breast implant. Tissue expansion typically lasts four to six months. The tissue expander is then replaced several months later with a breast implant (1).
Over the past 2 years, MedSun has received 10 adverse event reports involving Breast Tissue Expanders. These reports are associated with two manufacturers: Mentor Texas, Inc. (5), and Allergan, Inc. (5). The reports were submitted by 9 hospitals between July 2006 and July 2008. The reported device problems were:
• Leakage (5)
• Infection (4)
• Labeling (1)
There are no MedSun reports for this device involving a patient death during this time period. One report mentions a device malfunction and three reports mention device failure. There are 5 reports that mention a patient injury. The patient injuries listed below were reported in 5 of the 10 reports.
• Surgical Procedure (4)
• Infection, Bacterial (2)
• Surgical Procedure, Repeated (1)
There were no MedSun reports for this device involving a patient under the age of 21 during this time period. From the reports that listed patient age the average age was 47 years old with a standard deviation of 12. Of the reports that listed patient gender, 9 reports involved female patients and 1 report involved a male patient.
These MedSun reports contributed to FDA awareness of the device problems. FDA continues to review these devices and their adverse event reports in an effort to increase and uphold patient safety.
|Device||Device Identifiers||Event Description|
|ALLERGAN, MCGHAN STYLE EXPANDER BIOSPAN||No device identifiers available||THE PATIENT UNDERWENT BILATERAL SIMPLE MASTECTOMY WITH SENTINEL NODE BIOPSIES, FOLLOWED BY BILATERAL RECONSTRUCTION WITH TISSUE EXPANDERS ON THE SAME DAY. FORTY (40) DAYS LATER, THE PATIENT UNDERWENT REMOVAL OF RIGHT TISSUE EXPANDER DUE TO INFECTED RIGHT TISSUE EXPANDER. CULTURES WERE POSITIVE.|
|ALLERGAN||Catalog # 133MV-15||AN ALLERGAN TISSUE EXPANDER WAS IMPLANTED. IT WAS REMOVED 6 MONTHS LATER AS IT WAS LEAKING.|
|ALLERGAN, MCGHAN STYLE EXPANDER BIOSPAN||No device identifiers available||THE PATIENT UNDERWENT BILATERAL SIMPLE MASTECTOMY WITH BILATERAL RECONSTRUCTION WITH TISSUE EXPANDERS. ONE MONTH LATER, THE PATIENT UNDERWENT REMOVAL OF LEFT TISSUE EXPANDER DUE TO INFECTED LEFT TISSUE EXPANDER. POSITIVE CULTURES.|
|ALLERGAN||Catalog # 133MV15, Lot # 1480137||THE EXPANDER DID NOT REMAIN FULL. IT DEFLATED. UPON REMOVAL MULTIPLE HOLES WERE NOTED THROUGHOUT THE SURFACE OF THE SIZER. WHEN SQUEEZED IT RESEMBLED A SPRINKLER.|
|ALLERGAN||Lot # 5L030-OEM||TISSUE EXPANDER IMPLANTS DATED WITH STERILIZATION DATE, AND NO IDENTIFIABLE EXPIRATION DATE. THE ASSISTANT MANAGER OF THE OR CONTACTED THE MANUFACTURER, AND DID NOT RECEIVE A CLEAR ANSWER. THE QUALITY ASSURANCE DEPARTMENT OF THE MANUFACTURER CONTACTED, AND A FOUR YEAR GUARANTEE WAS GIVEN FOR STERILITY VERBALLY.|
|MENTOR TEXAS, INC., MENTOR||Catalog # 354-7213, Lot # 5874834||PATIENT HAD SURGERY: LEFT MASTECTOMY, RECONSTRUCTION WITH TISSUE EXPANDER AND ALLODERM. THEN, PATIENT REPORTED SYMPTOMS OF INFECTION: FEVER, REDNESS TO LEFT BREAST. PATIENT ADMITTED TO HOSPITAL AND TREATED WITH IV ANTIBIOTICS. PATIENT RETURNED FOR SURGERY: IRRIGATION, DEBRIDEMENT, AND REMOVAL OF 120 ML SALINE FROM TISSUE EXPANDER. TISSUE AND FLUID CULTURES TAKEN AND STAPHYLOCOCCUS AUREUS TREATED WITH IV ANTIBIOTICS. FINALLY, PATIENT RETURNED TO OR FOR REMOVAL OF TISSUE EXPANDER AND IMPLANTATION OF SILICONE GEL BREAST IMPLANT AND ALLODERM.|
|MENTOR TEXAS, INC., CONTOUR PROFILE BREAST TISSUE EXPANDER||Model # 354-6212 350CC, Lot # 589291504/30/2009||POST BILATERAL MASTECTOMY FOR CANCER, A BREAST TISSUE EXPANDER WAS IMPLANTED IN THE LEFT BREAST AREA. THE EXPANDER WAS FOUND TO BE LEAKING SALINE POSTOPERATIVELY AND WAS REMOVED THE FOLLOWING DAY. NO CRACKS WERE NOTED ON THE DEVICE.|
|MENTOR TEXAS, INC., MENTOR||No device identifiers available||PT HAD A LEAKING TISSUE EXPANDER.|
|MENTOR TEXAS, INC., SILTEX MED HT CONTOUR PROFILE XPNDR||Catalog # 354-6211, Lot # 5821619||THE TISSUE EXPANDER FAILED WHEN THE PHYSICIAN ATTEMPTED TO FILL IT WITH SALINE. THE DEVICE WAS REMOVED FROM THE PATIENT AND ANOTHER DEVICE WAS USED. NO HARM TO THE PATIENT.|
|MENTOR TEXAS, INC.|| Model # 354-6215, Lot # 5727244||LEFT BREAST TISSUE EXPANDER INTRAOPERATIVELY FILLED TO 420 CC A FEW MONTHS AGO REQUIRED EXPLANTATION WITH RE-INSERTION FIFTY-FOUR DAYS LATER WITH NEW EXPANDER. CULTURE AND SENSITIVITY OF SEROMA FLUID PENDING.|
1. 78372 Federal Register / Vol. 73, No. 246 / Monday, December 22, 2008 / Notices