Allergan Issues Worldwide Recall of Biocell Textured Breast Implants and Tissue Expanders
If you are a Breast Cancer Survivor or patient who has had breast reconstructive surgery using one of the following breast implants or tissue expanders, and has experienced problems, contact your breast doctor immediately (breast surgeon and/or plastic surgeon). This boob recall is for real and if you had cancer and have these implants, you may be at risk. The recall comes after a rare type of lymphoma cancer (ALCL) linked to textured breast implants. Learn more below and in the full article posted here.
If you have an implant and are concerned, don't hesitate to call your doctor. Definitely call your doctor if you have symptoms or problems with your implant, such as pain, lumps, swelling, or asymmetry, especially if these problems develop years after the implant was placed. You also can report implant problems on the FDA MedWatch reporting site. Select the consumer/patient form link.
The Breast FACTS:
On July 24, 2019, Allergan announced a global recall of Biocell textured breast implants and tissue expanders after the U.S. Food and Drug Administration (FDA) requested the recall.
The recall comes after a rare type of cancer called anaplastic large-cell lymphoma (ALCL) has been linked to textured breast implants. Lymphoma is cancer of the lymphatic system.
Currently, 38 other countries have recalled this implant because of its link to ALCL.
The FDA also updated the number of worldwide cases of ALCL associated with breast implants: 573 women have been diagnosed, and 33 women have died from the disease.
Of the 573 cases of ALCL, 481 are attributed to Allergan implants. Of the 33 deaths, the FDA reports that the implant maker was known for 13 women. Of these 13 women, 12 of them were confirmed to have an Allergan breast implant at the time of their ALCL diagnosis.
The Recalled Products:
The recalled Allergan 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
As a 12-year bi-lateral Breast Cancer Survivor, this article certainly caught my attention as I was the 4th Research patient in the state of New Jersey to participate in the Allergan clinical trial with the Natrelle 410FX gel implants also known as the gummy bear implants.
I did have numerous complications, and yes, I even had them replaced 4X between December 2007 and December 2011! It was an outrageous experience and one that I do not wish to go thru again but my survivorship taught me a lot about breast health and wellness and what women want and need to wear for quality post-surgical undergarments - hence my utility-patented collection of CRISSCROSSIntimates luxe post-surgical intimate apparel. I learned so much especially after enduring bilateral lumpectomy with radiation at first, then bilateral mastectomy with four reconstructive surgeries and complications within the first 18 months, MRSA, followed by breast cellulitis 3X as well, and other issues.
So with this week’s news, YES, I contacted both my Breast and Plastic Surgeons and await direction if I should need a simple blood test, or other tests, to rule out ACLA or begin discussions for my 5th reconstructive surgery or implant replacement (UGH)!
Earlier this year, I had my annual breast exam, blood marker tests, and even a 10-year MRI and although some fluid was found around both breasts, no further treatment was suggested. Now I am concerned about future implications and complications, as many of you may be too. It doesn’t hurt to ask the proper questions, to be vigilant and take the very breast care of your breast health and wellness. So while I await my direction, I shout-out to my sister-survivors, to share this story and report back with your updates.
Don’t Let Cancer Get the BREAST of You!
I wish you all the Breast!!
Jean Criss, Survivor, Designer & Founder, CRISSCROSSIntimates.com