What is an X-Plant

Self Advocate:  So here I am and what I'm wondering:  

• Why didn't I get a notification?  FDA recall?  
• No communication from Allergan/Abbie;
• No emails from concerned doctors;
• No letters from Stanford ;
• No email from Oncologist;
• Nothing in my health carts or health portals notifying me;
• No contact from breast surgeon;
• I was left to sort out what I wanted to do next.  

This experience has shaped me in so many ways, both personally and professionally. My journey through breast cancer, dealing with multiple doctors, and eventually facing the aftermath of recalled implants, taught me invaluable lessons in resilience, patience, and the importance of advocating for my health.

Article from FDA

AmericanCancerSociety   : What ACS suggests, click here

Allergan / AbbVie Recall:   the merger

Key Details of the Recall:

• Products Affected: All BIOCELL textured breast implants and tissue expanders, including specific Natrelle and Natrelle 410 models. 
• Reason for Recall: Increased risk of BIA-ALCL, a cancer of the immune system, found in the fluid or scar tissue around the implant. 
• FDA Action: The FDA requested the recall in July 2019, and Allergan voluntarily complied. 
• Not Breast Cancer: BIA-ALCL is a type of lymphoma, not breast cancer, but can spread. 

Allergan is a global pharmaceutical company, famous for products like BOTOX and eye care treatments (e.g., Restasis, Refresh), focusing on medical aesthetics, eye care, neuroscience, and gastroenterology, and is now an AbbVie company after being acquired by Actavis (which then renamed itself Allergan plc). They develop, manufacture, and market branded pharmaceuticals and medical devices, with a strong focus on innovation in areas like dermal fillers, body contouring, and regenerative medicine. 

The key FDA documents for the 2019 Allergan breast implant recall are the July 24, 2019, press release requesting the recall of BIOCELL textured implants and expanders, along with related Safety Communications, and subsequent Class 1 Device Recall notices (like the one dated September 11, 2019) posted on the FDA website. These documents detail the link to Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) and list the affected textured products, available for review on the FDA's medical device recall database. 

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