Allergan BIOCELL Textured Breast Implants - Q1 2022 Update
This litigation ended 2021 with a whimper. The last Order was the December 6, 2021, CASE MANAGEMENT ORDER NO. 24 that provided for the fair and equitable sharing among plaintiffs, and their counsel, of the burden of services performed and expenses incurred by attorneys acting for the common benefit of all plaintiffs in this complex litigation. This order typically is set up along the way of the litigation and prior to any settlement. This litigation is still very young. The Initial Case Management Conference was held on January 13, 2020. The prior CASE MANAGEMENT ORDER NO. 23 was entered on June 23, 2021, to address very preliminary procedural issues, namely, the Defendants’ filing of Answers to Plaintiffs’ Master Long Form Complaint for Personal Injuries and Plaintiffs’ Consolidated Class Action Complaint.
Q4 2021 Update
A year ago, you may have received a Notice from Allergan regarding the ConfidencePlus Warranty program. The MDL Judge ordered that one Notice be sent for corrective action and another to explain the legal ramifications for signing any “warranty” release documents in return for compensation. If you signed one of the Releases, please let us know. Original Releases signed between October 2, 2020 and the Stipulation date are VOIDED. Original Releases signed before October 2, 2020 are Not Voided.
Revised Releases do not release claims that are or could be asserted in this litigation by Plaintiffs or the putative classes, no matter when they were signed. Moving forward, if you receive anything other than a Revised Release, please let us know.
About the implants. Allergan has maintained that BIOCELL textured implants reduce capsular contracture rates compared to smooth implants. The truth from Allergan’s CORE Clinical Trial (Spear 2014)1 showed “capsular contracture rates were stratified by implant texture, which did not result in significant differences for smooth versus textured devices.”, from the Hall-Findlay 20112 study entitled “Breast Implant Complications Review: double capsules and Late Seromas, showed “Biocell texturing increased the capsular contracture rate.”, and from Van Slyke 20183 study entitled “Not All Breast Implants Are Equal: A 13-Year Review of Implant Longevity and Reasons for Explantation.” that “Biocell implants have the shortest time to explantation and are more frequently associated with problems related to implant performance failure, specifically pain.” Allergan’s Fine Print regarding Capsular Contracture “Textured surface implants were designed to reduce the chance of capsular contracture. Some information in the literature with small numbers of patients suggests that surface texturing reduces the chance of severe capsular contracture, but clinical information from studies of a large number of women with McGhan Medical implants shows no difference in the likelihood of developing capsular contracture with textured implants compared to smooth surfaced implants.”
Making the point more clear, the incidence of Primary Breast T-Cell lymphoma Anaplastic Large-Cell Lymphoma in the general population of women is 3.7 per 100 million women, or .037 per million. The incidence of women with Allergan Textured Breast Implants is .3102% per million. This means that a woman with Allergan textured implants is 83,838 times more likely to develop Tcell ALCL in her breast than a woman in the general population. Again, this is all related to the textured implants. Some textures are worse than others, but Allergan’s Biocell texture is associated with more cases—by far—than any other textured implant.
Revised Releases do not release claims that are or could be asserted in this litigation by Plaintiffs or the putative classes, no matter when they were signed. Moving forward, if you receive anything other than a Revised Release, please let us know.
About the implants. Allergan has maintained that BIOCELL textured implants reduce capsular contracture rates compared to smooth implants. The truth from Allergan’s CORE Clinical Trial (Spear 2014)1 showed “capsular contracture rates were stratified by implant texture, which did not result in significant differences for smooth versus textured devices.”, from the Hall-Findlay 20112 study entitled “Breast Implant Complications Review: double capsules and Late Seromas, showed “Biocell texturing increased the capsular contracture rate.”, and from Van Slyke 20183 study entitled “Not All Breast Implants Are Equal: A 13-Year Review of Implant Longevity and Reasons for Explantation.” that “Biocell implants have the shortest time to explantation and are more frequently associated with problems related to implant performance failure, specifically pain.” Allergan’s Fine Print regarding Capsular Contracture “Textured surface implants were designed to reduce the chance of capsular contracture. Some information in the literature with small numbers of patients suggests that surface texturing reduces the chance of severe capsular contracture, but clinical information from studies of a large number of women with McGhan Medical implants shows no difference in the likelihood of developing capsular contracture with textured implants compared to smooth surfaced implants.”
Making the point more clear, the incidence of Primary Breast T-Cell lymphoma Anaplastic Large-Cell Lymphoma in the general population of women is 3.7 per 100 million women, or .037 per million. The incidence of women with Allergan Textured Breast Implants is .3102% per million. This means that a woman with Allergan textured implants is 83,838 times more likely to develop Tcell ALCL in her breast than a woman in the general population. Again, this is all related to the textured implants. Some textures are worse than others, but Allergan’s Biocell texture is associated with more cases—by far—than any other textured implant.