Allergan Recalls Textured Breast Implant

The FDA reports that Textured Surface Breast implants, unique to Allergan’s implants, are tied to 481 cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma.

There have been 573 cases of BIA-ALCL worldwide, including 33 deaths. In 13 cases where a patient died and the manufacturer of the breast implant was known, 12 of them involved an Allergan breast implant.

Most cases of this particular cancer, which attacks the immune system, are not diagnosed for years after the original implantation.

The risk of getting BIA-ALCL from an Allergan textured implant is 6 times the risk compared to similar products from other manufacturers. Textured implants represent 10% of all breast implants sold in the United States.

Allergan is taking this action as a precaution following notification of recently updated global safety information concerning the uncommon incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) provided by the U.S. Food and Drug Administration (FDA).

Receiving the diagnosis of BIA-ALCL may cause anxiety and fear. Patients should know that not all cancers are equal. When caught early, BIA-ALCL is curable in most patients.

BIA-ALCL is a rare type of Lymphoma that can develop in the scar tissue surrounding breast implants.

BIA-ALCL occurs most frequently in patients who have breast implants with textured surfaces. This is a cancer of the immune system, not a type of breast cancer. The current lifetime risk of BIA-ALCL is estimated to be 1:1,000 - 1:30,000 for women with textured implants.

Textured breast implants have a rough surface that is sometimes compared to sandpaper. Unlike smooth-surfaced implants, their surface adheres to the tissue that surrounds them, preventing them from moving around within the implant pocket created by the surgeon. This is especially beneficial for implants that are not round but tear-drop shaped, because movement or rotation of these implants would cause the patient’s chest to appear misshapen.

Common symptoms include:

• Breast enlargement
• Pain
• Asymmetry
• Lump in the breast or armpit
• Overlying skin rash
• Hardening of the breast
• Large fluid collection typically developing at least more than one year after receiving an implant

*For any patient experiencing these or any symptoms, they should see their doctor for evaluation.
BIA-ALCL has been found with both silicone and saline implants and both breast cancer reconstruction and cosmetic patients. BIA-ALCL appears to involve patients who have an allergic reaction or infection to textured devices over many years.

• Your physician will refer her for a PET/CT scan to look for any disease that may have spread throughout the body. Any spread of the disease determines the stages, which is important for treatment
• Diagnosed patients will be referred to an oncologist for evaluation of BIA-ALCL, staging of disease, and treatment planning
• For patients with BIA-ALCL only around the implant, surgery is performed to remove the breast implant and the scar capsule around the implant
• Lumps in the armpit may be disease that has spread to the lymph nodes or may still be a normal enlargement of the lymph nodes. Testing of the lymph nodes may be performed with a needle biopsy or with a surgery to remove a lymph node for testing. Additional tests may sometimes include blood tests and a bone marrow biopsy
• Some patients with advanced cases may require further treatment with chemotherapy and in rare cases include radiation therapy and/or stem cell transplant therapy

The U.S. Food and Drug Administration (FDA) recommend that all confirmed cases be reported to the PROFILE registry. The PROFILE registry is a joint effort of the FDA and ASPS/PSF. If you have been diagnosed with BIA-ALCL, please ensure your physician has reported the case to the PROFILE registry for tracking of cases. Information reported to PROFILE is updated with the FDA on a monthly basis.

Miller Weisbrod Olesky, Attorneys At Law, represents victims of defective medical devices in lawsuits against major medical product manufacturers. Our team of attorneys can offer you sound legal advice and decades of experience fighting against big medical device corporations nationwide. We put our knowledge and in-depth trial experience to work on your behalf to achieve the just compensation you deserve for your injuries.

To discuss your rights and legal options with an experienced medical products liability attorney, please call our Dallas office at 214.987.0005. Clients outside the DFW area can call us toll free at 888.987.0005. You may also contact us by e-mail now for answers to your important questions or to schedule a free consultation.