Breast Implant Recall

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The FDA Requested Allergan Recall all Breast Implants and Tissue Expanders from the Market to Protect Patients

The Food and Drug Administration ("FDA") has requested that Allergan recall all BIOCELL textured breast implants and tissue expanders marketed in the U.S. based on newly submitted Medical Device Reports reporting increased worldwide cases of anaplastic large cell lymphoma (BIA-ALCL) related deaths associated with these devices. Allergan has agreed to recall its BIOCELL textured breast implants and tissue expanders from the global market.

The FDA revealed a new worldwide reported total of 573 unique BIA-ALCL cases including 33 patient deaths. Of the 573 cases, 481 are reported to have Allergan breast implants at the time of diagnosis. In addition, 12 of the 13 deaths occurring where the manufacturer was known occurred in patients implanted with Allergan breast implants at the time of their diagnosis. Based on this information, the FDA determined that the risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately six times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S.

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FDA identified the following affected products

Allergan Natrelle Saline-Filled Breast Implants (formerly McGhan RTV Saline-Filled Mammary Implant) approved under P990074. The following are the textured styles:

Style 163 – BIOCELL Textured Shaped Full Height, Full Projection Saline Breast Implants
Style 168 – BIOCELL Textured Round Moderate Profile Saline Breast Implants, also referred to as 168MP (168 Moderate Profile)
Style 363 – BIOCELL Textured Shaped Moderate Height, Full Projection Saline Breast Implants, Allergan catalog includes 363LF, or 363 Low Height Full Projection
Style 468 – BIOCELL Textured Shaped Full Height Moderate Projection Saline Breast Implants

Allergan Natrelle Silicone-Filled Textured Breast Implants (formerly Inamed Silicone-Filled Breast Implants) approved under P020056. The following are the textured styles:

Style 110 – BIOCELL Textured Round Moderate Projection Gel Filled Breast Implants
Style 115 – BIOCELL Textured Round Midrange Projection Gel Filled Breast Implants
Style 120 - BIOCELL Textured Round High Projection Gel Filled Breast Implants
Style TRL - Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants
Style TRLP - Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants
Style TRM - Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants
Style TRF - Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants
Style TRX - Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants
Style TCL – Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants
Style TCLP – Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants
Style TCM – Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants
Style TCF – Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants
Style TCX – Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants
Style TSL – Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants
Style TSLP – Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants
Style TSM – Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants
Style TSF – Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants
Style TSX – Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants

Natrelle 410 Highly Cohesive Anatomically Shaped Silicone Filled Breast Implants approved under P040046. The following are the textured styles:

Style 410FM
Style 410FF
Style 410MM
Style 410 MF
Style 410 FL
Style 410 ML
Style 410 LL
Style 410 LM
Style 410 LF
Style 410 FX
Style 410 MX
Style 410 LX

Allergan tissue expanders for the breast that have BIOCELL texturing originally cleared as:

Natrelle 133 Plus Tissue Expander (K143354)
Natrelle 133 Tissue Expander with Suture Tabs (K102806)

If you or someone you know has been affected, please contact us.

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