Allergan enticed patients with the idea that its BioCell textured breast implants were more natural-looking. What is not natural, however, is the resulting diagnosis of a rare type of lymphoma: BIA-ALCL (or breast implant associated anaplastic large cell lymphoma). The Food and Drug Administration (FDA) issued a Class 1 recall in September after requesting Allergan issue a voluntary recall in August. The FDA found the risk of BIA-ALCL from Allergan textured implants to be six (6) times more than other similar brands.
The products included in the recall according to the FDA notice are the Allergan Natrelle BIOCELL textured implant products as follows:
Allergan Natrelle Saline-Filled Textured Breast Implants
Allergan Natrelle Silicone-Filled Textured Breast Implants
Allergan Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone- Filled Textured Breast Implants
Allergan Natrelle 133 Plus Tissue Expander
Allergan Natrelle 133 Tissue Expander with Suture Tabs
Lot numbers: All lots (for complete listing of all styles, see the FDA Safety Communication)
Manufacturing Dates: July 25, 2014 - June 21, 2019
Distribution Dates: September 14, 2014- July 24, 2019
Devices Recalled in the U.S.: 246,381
Although a FDA Class 1 recall is the most serious but does not necessarily mean that all patients will suffer injury or need to have the product removed. Patients with affect products should talk to their doctors and closely monitor any potential symptoms of BIA-ALCL. These symptoms may include excessive fluid buildup around the breast implant, which can result in severe pain, swelling or lumps in the breast or armpit area. Symptoms may not occur right away and can often take several years if not a decade or more to be revealed.
According to the FDA, there were 573 worldwide reported total cases of BIA-ALCL as of September. Of that number a whopping 481 had Allergan breast implants at the time of diagnosis. 12 deaths have been reported as a result.
If you or someone you know has been affected by Allergan breast implants or have been diagnosed with BIA-ALCL after breast augmentation, call us now for a free consult. You will need a smart and honest lawyer to take on Allergan and its insurance company. We have decades of experience recovering real dollars for our clients against big medical devices companies. Call us now, 281-280-8900 or email us at assistant@jamesdeanlaw.com.