Allergan Breast Implant Recall
When people go in for elective surgery, they expect a guarantee that the product is tested and safe. Nobody would opt for a surgery if they have reason to know there is a safer alternative that gives them the exact same result. Every year medical devices and products are recalled, but for many people, its already too late. If you have been injured by a product that was later recalled, you have a strong case for a products liability lawsuit.
On July 24, 2019, the FDA recalled breast implants manufactured by Allergan Biocell®. The Implants are saline and silicone filled textured breast implants. The shell is unique and only used be Allergan. The recall was in response to a finding that the implants may cause a form of cancer known as Anaplastic Large Cell Lymphoma (BIA-ALCL). This is a form of non-Hodgkins Lymphoma: cancer originating in the lymphatic system. In most patients, cancer is found in the area around the implant but has the potential to spread throughout their entire body. Symptoms include persistent swelling and pain as well as the development of seromas, or fluid build-up under the surface of the skin. In most patients, BIA-ALCL can be treated with surgery to remove the implant and scar tissue around the implant, but some may require chemotherapy or radiation therapy.
Before the recall in July, many countries across the world had already suspended use of these implants. These particular implants are linked to a higher risk than other breast implants. 573 cases of BIA-ALCL tracing back to implants have been discovered worldwide, 481 of which involved Allergan implants. What’s more, of 33 deaths resulting from BIA-ALCL induced by breast implants, more than 90% involve Allergan implants. The risk of these implants is more than six times the risk with textured implants from other providers.
The FDA is recommending the following:
- No recommendation for patients with no symptoms. The actual incidence of developing BIA-ALCL is quite low.
- Know the symptoms and monitor the area around the implant.
- If you experience symptoms talk to health-care provider.
- If you are diagnosed with BIA-ALCL, have the implant and scar tissue around it removed.
- Keep a record of device manufacturer, device identifier, and implant model name.
- Understand that many cases may not come to light until many years after breast implant placement.
Here is what is being recalled:
- Natrelle Saline-Filled breast implants (Styles 163, 168, 363 and 468)
- Biocell Textured Round Gel-Filled Implants (Styles 110, 115 & 120)
- Natrelle Inspira Silicone-Filled breast implants (Styles TRL, TRLP, TRM, TRF, TRX, TCL, TCLP, TCM, TCF, TCX, TSL, TSLP, TSM, TSF, and TSX)
- Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants
- Natrelle 133 Plus Tissue Expander
- Natrelle 133 Tissue Expander with Suture Tabs
- Some products have formerly been sold under the brand names McGhan and Inamed. See your health provider to determine if you have one of these.
Physicians highly recommend that any people who have had procedures involving these materials remove them.
The process of having these implants removed can be a physically and emotionally taxing process. The manufacturer should have gotten it right the first time around, and you are entitled to compensation for its mistakes. Our skilled products liability attorneys at Altman & Altman LLP will assess the liability of all parties involved. We have access to product and medical experts that prove invaluable in these types of cases. If you or a loved one has been injured by the use of Allergan implants, please do not hesitate to contact us. Our phones are answered 24 hours a day, 7 days a week. In addition, all emails are responded to within 4 hours, often sooner.
You will not be charged a penny until we recover on your behalf.