Allergan breast implants linked to a rare form of cancer were recently recalled nationwide by the U.S. Food & Drug Administration. In late July, the agency announced the implants would also be recalled globally.
The FDA’s decision to recall Allergan textured breast implants which use the company’s Biocell technology comes after an increasing number of women have been diagnosed with implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare form of cancer which affects the immune system, and which may be fatal if left untreated.
Here are some details about Allergan breast implants and their links to cancer:
- According to the FDA, there have been over 570 cases of BIA-ALCL worldwide, 33 of which resulted in death. Regulators have reported that at least 481 of those cases were linked to Allergan Biocell implants, and that 12 of the 13 fatal cases where the type of implant was known involved implants made by Allergan.
- BIA-ALCL associated with Allergan implants is not breast cancer, but instead a type of cancer which develops in the tissue surrounding implants. In the majority of cases, health care professionals are able to successfully cure the condition by removing the implant and scar tissue, but without medical intervention, the cancer can spread and cause death.
- The FDA has been monitoring links between Allergen Biocell implants and cancer since 2011, and has issued both a recall and a safety communication for women who have had breast enlargement procedures and reconstructive surgery following mastectomy for breast cancer, as well as women who are considering such procedures.
- FDA officials say Allergan Biocell textured implants carry roughly six times the cancer risks compared to other textured implants sold in the U.S. They noted hundreds of thousands of women in America currently have the recalled Biocell textured implant products, which include: Natrelle Saline-Filled breast implants, Natrelle Silicone-Filled breast implants, Natrelle Inspira Silicone-Filled breast implants, and Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants, as well as Natrelle 133 Plus Tissue Expander and Natrelle 133 Tissue Expander with Suture Tabs.
The FDA has been careful to note that the recall was issued in an abundance of caution, but statistics released by the agency show there are real, warranted concerns for women with Biocell implants. Many women and victims are impacted by implant-associated lymphoma are increasing existing efforts to ban textured implants in the U.S. entirely.
In addition to preventing their continued use by health care providers, the recall helps spread awareness among women experiencing symptoms of BIA-ALCL – which include pain, swelling, and fluid accumulation around the implant. Women experiencing these symptoms should speak with their doctors about draining the fluid and testing for cancer. Women with the implants who have no symptoms do not need to remove the implants, the FDA said.
You can find more information about Allergan breast implants and BIA-ALCL on this FDA press announcement.
Product Liability & Victims’ Rights
Levinson Axelrod, P.A. encourages women who have experienced symptoms associated with BIA-ALCL to seek immediate medical attention. As a civil trial law firm that handles cases involving defective products, we’re also available to help victims and families learn more about their rights and options for pursuing legal action.
Under product liability laws, manufacturers of defective products can be held financially liable for damages suffered by victims – including their medical expenses, lost income, pain and suffering, and more. Our firm can help you explore whether you may have a valid claim, and explain how we can fight for the compensation you deserve.
To speak personally with a Levinson Axelrod attorney about your potential claim and how we can help, call (732) 440-3089 or contact us online. Consultations are free and confidential.