FDA recalls Allergan-Brand Breast Implants After Cancer Link
August 28, 2019
Countries across the globe have been calling on Allergan to recall many of its textured breast implant products, and the U.S. Food and Drug Administration (FDA) recently followed suit.
Allergan, a Dublin-based manufacturing company, issued a worldwide recall for some of its textured saline and silicone-filled implants, as well as models of tissue expanding products used during breast implant surgeries. This major recall comes after information linking Allergan’s products to increased rates of breast implant-associated anaplastic large cell lymphoma, a rare but deadly form of lymphoma.
FDA Data on Allergan Products and Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)
According to data from the FDA, recent years have seen a “significant increase” in breast implant-associated lymphoma. So far, there have been five hundred and seventy-three cases, thirty-three of which were fatal. The FDA attributed a whopping four hundred and eighty-one – and twelve deaths – directly to use of Allergan’s textured breast implant products. The agency also says the incident rate is growing rapidly: more than one-fifth of the total cases were reported in the last year alone, as well as more than 70% of the cancer’s associated fatalities.
Amy Abernethy, M.D., Ph.D., and Principal Deputy Commissioner to the FDA, said that despite overall incidence rates of breast implant-associated anaplastic large cell lymphoma appearing to be low, that “evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death.” Because of the direct link between Allergan’s products and the serious and deadly harm they cause to patients, the FDA decided to move forward with its recall request.
Which Allergan Breast Implant Products Have Been Recalled?
The recall of Allergan’s products includes the following models and products:
- Natrelle Silicone-Filled breasts implants
- Natrelle Saline-Filled breast implants
- Natrelle Inspira Silicone-Filled breast implants
- Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants
- Natrelle 133 Tissue Expander with Suture Tabs, and:
- Natrelle 133 Plus Tissue Expander
As part of its recall, the FDA has also issued a safety communication for all patients with breast implants or who are considering getting breast implants. The safety communication is also designed for physicians and healthcare professionals outlining known risks to patients and instructing them how to effectively monitor for symptoms. To read the FDA’s official press release or to learn more about the safety communication, please visit: https://www.fda.gov/news-events/press-announcements/fda-takes-action-protect-patients-risk-certain-textured-breast-implants-requests-allergan.
Symptoms of Breast Implant-Associated Anaplastic Large Cell Lymphoma
Breast implant-associated anaplastic large cell lymphoma is not a kind of breast cancer; it is actually a type of non-Hodgkin’s lymphoma, or a cancer of the immune system. Early identification and treatment are some of the best ways to save a person’s life. Here are some of the most well known symptoms L:
- Swelling and/or pain in or around the breast(s);
- Changes in implant or overall breast shape (including an increase in breast size);
- Swollen lymph nodes;
- Itching or redness of the skin on or near the breast;
- The development of a lump or lumps in or around the breast or under the armpit;
- Development or an increase in breast asymmetry, and:
- Severe fatigue, fever, and/or nightsweats
If you are someone with breast implants and you are experiencing any of the symptoms, it is critical to see a doctor right away.
Philadelphia Products Liability Lawyers at Galfand Berger, LLP Represent Victims of Dangerous Medical Products
If you or a loved one has been injured, after receiving Allergen’s saline or silicone filled breast implants, call one of Philadelphia products liability lawyers review your case for free. Galfand Berger has offices located in Philadelphia, Bethlehem, Lancaster, and Reading, and we serve clients throughout Pennsylvania and New Jersey. To schedule a consultation, call us at 800-222-8792 or complete our online contact form.