Textured breast implants account for only about 5 percent of total breast implant procedures in the United States, according to the New York Times. On Wednesday, the United States Food and Drug Administration (FDA) issued actions designed to restrict the sale and use of textured breast implants from Allergan. The FDA Allergan recall was issued after conclusive evidence came out connecting the company’s implants to Breast Implant-Associated Large-Cell Lymphoma (BIA-ALCL).
What Led to The FDA Allergan Recall
In a statement released by the FDA, Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. justified the FDA Allergan recall by stating:
“Although the overall incidence of BIA-ALCL appears to be relatively low, once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women’s health.”
According to their press statement, the FDA requested that Allergan recall devices from their BIOCELL product line including:
- Natrelle Saline-Filled breast implants
- Natrelle Silicone-Filled breast implants
- Natrelle Inspira Silicone-Filled breast implants
- Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants
- Natrelle 133 Plus Tissue Expander
- Natrelle 133 Tissue Expander with Suture Tabs
These products were targetted by the FDA Allergan recall following an updated report that recorded 573 cases of complications and 33 deaths from BIA-ALCL. The report significantly expanded the FDA’s number of cases by 116 complication cases and 24 deaths from earlier this year.
Of the 573 complication cases, 481 could be “clearly attributed” to Allergan implants, approximately 84%. From 33 deaths the type of implant was known in 13. Of those 13 deaths, 12 were products made by Allergan. That means that 36% of the fatal cases of BIA-ALCL were attributed to Allergan in a report where only 39% of the cases could recover breast implant information.
The FDA Allergan recall announcement also included information about identifying BIA-ALCL development in the body, citing main symptoms as swelling and fluid accumulation around the implant. If those symptoms occur, the FDA recommends that the fluid should be drained and tested for BIA-ALCL.
The FDA has also determined that implant filling, usually silicone or saline, is irrelevant to the development of BIA-ALCL. According to the FDA, the only major factor at play for the development of BIA-ALCL is whether the covering is textured. With these revelations, the FDA hopes that the FDA Allergan recall will help to preserve women’s health moving forward.
For more information about BIA-ALCL and the risks posed by textured breast implants, visit Parker Waichman’s Textured Breast Implants Page.
How The FDA Allergan Recall Helps Litigation
The FDA Allergan recall is a great step forward in the name of women’s health. The recall has not only instructed doctors and hospitals to end implants and should return any in storage to Allergan, but it has also helped to inform the nation of this serious threat.
Despite this, it does come after BIA-ALCL has affected hundreds of women across the nation. For those women, compensation is owed for the FDA’s slowness to act. Luckily for those affected, the FDA’s identification of Allergan’s textured implants as a definitive cause gives great credence to lawsuits filed against the manufacturer. If you or a loved one are thinking of pursuing justice for your BIA-ALCL complications, be sure to move forward with a law firm that will be able to earn the compensation that you deserve. Choose Parker Waichman LLP.
At Parker Waichman LLP, teams of experienced trial attorneys are prepared to take your case to its ultimate ends in order to ensure that you get the compensation that you are entitled to. Let Parker Waichman be your voice as you cry out for justice. Contact Parker Waichman today for a free consultation.
