Sauder Schelkopf filed the first nationwide class action lawsuit to protect individuals from the increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), associated with Allergan BIOCELL textured breast implants. The Food and Drug Administration (FDA) recently requested that Allergan recall its BIOCELL textured breast implants and tissue expanders. Allergan agreed and is removing these products from the global market.
The FDA requested Allergan’s recall of all BIOCELL textured breast implants and tissue expanders based on newly submitted Medical Device Reports (MDRs) reporting worldwide cases of BIA-ALCL and BIA-ALCL-related deaths associated with these devices. The FDA’s “analysis was attributed to a new worldwide reported total of 573 unique BIA-ALCL cases including 33 patient deaths. Of the 573 cases of BIA-ALCL, 481 are reported to have Allergan breast implants at the time of diagnosis. In addition, 12 of 13 deaths occurring in patients with BIA-ALCL where the manufacturer was known occurred in patients implanted with an Allergan breast implant at the time of their BIA-ALCL diagnosis. The manufacturer and/or texture is unknown for the remaining 20 reported deaths from BIA-ALCL.”
“Our national class action lawsuit seeks to cover the costs associated with explanting the recalled breast implants and replacing them with non-recalled breast implants. Our clients and the many women who have contacted us should not have to deal with the anxiety of living with a recalled breast implant. We look forward to fighting on their behalf in seeking a resolution that provides them peace of mind” said plaintiff’s attorneys Joe Sauder and Matt Schelkopf of Sauder Schelkopf.
The FDA “analysis demonstrates that the risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately 6 times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S. and continued distribution of Allergan’s BIOCELL textured breast implants would likely cause serious, adverse health consequences and potentially death from BIA-ALCL.”
FDA statement as of August 7, 2019 here
Class Action Press Release here
According to the FDA, the recalled products include:
|Natrelle Saline breast implant styles 168, 363, 468|
|Natrelle and McGhan 410 breast implant styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX|
|Natrelle and McGhan 410 Soft Touch breast implant styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX|
|Natrelle 510 Dual-Gel styles LX, MX, FX|
|Natrelle INSPIRA breast implants, styles TRL, TRLP, TRM, TRF, TRX, TSL, TSLP, TSM, TSF, TSX, TCL, TCLP, TCM, TCF, TCX|
|Natrelle and McGhan Round Gel Implants, styles 110, 110 Soft Touch, 120, 120 Soft Touch|
|Natrelle Komuro breast implants styles KML, KMM, KLL, and KLM|
|Natrelle Ritz Princess breast implant styles RML, RMM, RFL, RFM|
|Natrelle 150 Full Height and Short Height double lumen implants|
|Natrelle 133 tissue expanders with and without suture tabs: styles 133FV, 133MV, 133LV, 133MX, 133SX, 133SV, T-133FV,|
T-133MV, T-133LV, T-133MX, T-133SX, T-133SV, 133FV-T, 133MV-T, 133LV-T, 133MX-T, 133SX-T, 133SV-T
|Natrelle 133 Plus tissue expander styles 133P-FV, 133P-MV, 133P-LV, 133P-MX, 133P-SX,|
133P-SV, T-133P-FV, T-133P-MV, T-133P-LV, T-133P-MX, T-133P-SX, T-133P-SV, 133P-FV-T, 133P-MV-T, 133P-LV-T, 133P-MX-T, 133P-SX-T, 133P-SV-T
Sauder Schelkopf is a nationally recognized class action and personal injury law firm. The firm’s partners currently serve as court appointed lead counsel in courts across the country and have been selected by the National Trial Lawyers Association as some of the Top 100 Trial Lawyers in Pennsylvania since 2012. The attorneys at Sauder Schelkopf have recovered over $500 million on behalf of their clients and class members.
We Want to Hear from You
If you have one of the recalled breast implants, contact the attorneys at Sauder Schelkopf by submitting your information below.