BIA-ALCL symptoms

The most common symptoms of BIA-ALCL are swelling (due to fluid build-up) or pain in the area of a textured breast implant. These symptoms tend to develop years after the implant is placed (on average, 7-10 years), but they may develop earlier. Some patients have had a lump adjacent to the implant surface or a lump in the lymph node in the armpit. Other less common symptoms can include enlarged lymph nodes, skin rash, fever, and weight loss.

Diagnosis of BIA-ALCL

According to guidelines from the National Comprehensive Cancer Network (NCCN), if BIA-ALCL is suspected, doctors should order imaging with ultrasound or MRI. If the imaging results show more than minimal fluid collection around the implant or a mass near the implant, then a sample of the fluid should be collected using fine needle aspiration (a thin needle inserted through the skin). The fluid should be tested for CD30, a protein that is found in higher than normal amounts on lymphoma cells, particularly in BIA-ALCL. If the fluid tests positive for CD30, the fluid should also be tested for anaplastic lymphoma kinase (ALK), a protein that helps control cell growth. In BIA-ALCL, the lymphoma cells do not make the ALK protein, so they test negative for ALK. A mass should be evaluated using a tissue biopsy.

Treatment for BIA-ALCL

If the pathology results indicate BIA-ALCL, the NCCN guidelines recommend surgery to remove the implants and the entire surrounding scar tissue capsules. The surgeon should perform an “en bloc capsulectomy” (removing the breast implant and the capsule of scar tissue surrounding it in one piece). Even if only one implant is affected by BIA-ALCL, both implants should be removed. If there are any masses (tumors) or any involved or suspicious lymph nodes, those should also be removed during the surgery.

Some patients have also required radiation therapy, chemotherapy, and/or stem cell transplant therapy.

Since BIA-ALCL is so rare and is a relatively newly identified illness, not many doctors have experience diagnosing and treating it. A number of patients have reported that they did not receive appropriate care when they were going through the process of being diagnosed and treated for BIA-ALCL. Outcomes after BIA-ALCL treatment

For patients who receive appropriate and timely treatment, the prognosis is very good. Research has shown that 93% of patients are disease-free at 3 years following treatment

                                       

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                                                      Allergan Breast Implant Recall List

An FDA analysis demonstrates that the risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately 6 times the risk of BIA-ALCL with textured implants from other manufacturers

Allergan Natrelle Saline-Filled Breast Implants (formerly McGhan RTV Saline-Filled Mammary Implant) approved under P990074. The following are the textured styles:

  • Style 163 – BIOCELL Textured Shaped Full Height, Full Projection Saline Breast Implants
  • Style 168 – BIOCELL Textured Round Moderate Profile Saline Breast Implants, also referred to as 168MP (168 Moderate Profile)
  • Style 363 – BIOCELL Textured Shaped Moderate Height, Full Projection Saline Breast Implants, Allergan catalog includes 363LF, or 363 Low Height Full Projection
  • Style 468 – BIOCELL Textured Shaped Full Height Moderate Projection Saline Breast Implants 

Allergan Natrelle Silicone-Filled Textured Breast Implants (formerly Inamed Silicone-Filled Breast Implants) approved under P020056. The following are the textured styles:

  • Style 110 – BIOCELL Textured Round Moderate Projection Gel Filled Breast Implants
  • Style 115 – BIOCELL Textured Round Midrange Projection Gel Filled Breast Implants
  • Style 120 - BIOCELL Textured Round High Projection Gel Filled Breast Implants
  • Style TRL - Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants
  • Style TRLP - Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants
  • Style TRM - Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants
  • Style TRF - Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants
  • Style TRX - Natrelle Inspira BIOCELL Textured Responsive Silicone-Filled Breast Implants
  • Style TCL – Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants
  • Style TCLP – Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants
  • Style TCM – Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants
  • Style TCF – Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants
  • Style TCX – Natrelle Inspira BIOCELL Textured Cohesive Silicone-Filled Breast Implants
  • Style TSL – Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants
  • Style TSLP – Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants
  • Style TSM – Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants
  • Style TSF – Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants
  • Style TSX – Natrelle BIOCELL Textured Soft Touch Silicone-Filled Breast Implants

Natrelle 410 Highly Cohesive Anatomically Shaped Silicone Filled Breast Implants approved under P040046. 

Allergan tissue expanders for the breast that have BIOCELL texturing originally cleared as:

Natrelle 133 Plus Tissue Expander (K143354)Natrelle 133 Tissue Expander with Suture Tabs (K102806)

         Allergan Implants have been associated with Breast Implant Illness 

Breast implant illness (BII) is a term that some women and doctors use to refer to a wide range of symptoms that can develop after undergoing reconstruction or cosmetic augmentation with breast implants. It is also sometimes referred to as autoimmune/inflammatory syndrome induced by adjuvants (ASIA). 

BII impacts each individual in a unique way. Symptoms can include:

  • joint and muscle pain
  • chronic fatigue
  • memory and concentration problems
  • breathing problems
  • sleep disturbance
  • rashes and skin problems
  • dry mouth and dry eyes
  • anxiety
  • depression
  • headaches
  • hair loss
  • gastrointestinal problems

The symptoms can appear any time after implant surgery — some people develop symptoms immediately, while some develop them years later.

A lot of the symptoms of BII are associated with autoimmune and connective tissue disorders, such as lupus, rheumatoid arthritis, and scleroderma. Some people who have BII also get diagnosed with a specific autoimmune or connective tissue disorder, but many do not.

In many, but not all cases, surgery to remove the breast implants improves or completely resolves the BII symptoms.

If you or a loved one has an Allergan textured implant, contact the attorneys at Ennis & Ennis, P.A. for a free confidential consultation to discuss your legal rights. Contact us 24/7 at 800-856-6405.