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What the Heck? Textured Breast Implants Stay on Market Despite Lymphoma Link.

Medical Device Watch
July 18, 2019
Textured Breast Implants and Lymphoma

Despite 732 confirmed cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), including 21 deaths, the U.S. Food and Drug Administration (FDA) recently announced its decision to keep textured breast implants on the market, citing a “lack of definitive evidence demonstrating breast implants cause these symptoms.”  Countries such as France, Canada and the Netherlands have already  banned the implants, previously lauded because of their superior adhesion to surrounding tissue which helped them to stay in place.  A proposed ban on the devices in Australia has also been initiated by its FDA counterpart, the Therapeutic Goods Administration (TGA).  

Symptoms of breast implant-associated anaplastic large cell lymphoma  (BIA-ALCL).

Breast implant-associated anaplastic large cell lymphoma often first presents as a build-up of fluid in the scar tissue surrounding the breast.  Some theorize BIA-ALCL may be linked to a bacterial infection introduced to the site during the initial surgery.  Symptoms commonly appear about eight to ten years after receiving an implant.  Some of the most common symptoms of BIA-ALCL include:

Patients have also reported other health conditions involving their overall immune response to the implants, including chronic fatigue, cognitive issues, joint and muscle pain, and frequent infections.  

Diagnosis and treatment of BIA-ALCL.

The good news is BIA-ALCL is usually curable if caught early.  Treatment usually includes removing the implant and surrounding scar tissue.  There is currently no testing or screening for women who have no symptoms.  If symptoms do appear, your doctor may order a magnetic resonance imaging or ultrasound to check for lumps and swelling.  If a fluid or mass is detected, your physician will need to biopsy fluid from the mass.  If the biopsy is positive for BIA-ALCL, your doctor will conduct further PET/CT scans to see if the disease has spread to other parts of the body.  Removing the implant and surrounding tissue is all that is often required for cases that are caught early. However, if the disease has spread, treatment may require removal of lymph nodes, chemotherapy, and in the most rare cases, radiation and/or stem cell transplant therapy.

Textured breast implant victims suffering from BIA-ALCL let down by FDA reporting process.

While the FDA has known about the issues with textured breast implants since at least 2011, manufacturers have only been required to file individual incident reports as of May of this year.  Prior to this, manufacturers were allowed to accumulate an internal list of incidents and merely submit quarterly spreadsheets reporting only summaries of commonly occurring problems through the FDA’s “alternative summary reporting program,” an initiative designed to reduce paperwork and time spent on reporting singular incidents of injury or malfunction of medical device implants.  

As a result of textured breast implants falling into the FDA’s alternative summary reporting program, surgeons and patients alike have been inadequately informed of the many complications and risks that have been experienced by patients.  And, textured breast implants are just one of many medical device implants currently under scrutiny due to the FDA’s problematic system of approving devices without clinical studies to show that the products are safe for human use.    

Steps you should take if your textured breast implants have caused BIA-ALCL.

If you’ve been diagnosed with BIA-ALCL, you should make sure your doctor reports your case to the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (ALCL) Etiology and Epidemiology (PROFILE) registry.  The registry is a joint venture by the FDA and the Plastic Surgery Foundation to collect real world data on the safety and performance of breast implants.  

Financial compensation for your medical expenses, pain and suffering, and more may be available through a breast implant cancer lawsuit.  If you or a loved one has been injured by a textured breast implant, you may want to consult with an attorney experienced in product liability litigation.  

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Medical Device Watch is sponsored by Wilentz, Goldman & Spitzer, P.A. The medical device approval process in the U.S. allows for the sale of some devices that have not been tested in clinical trials on humans. Our goal is to help people protect themselves from the physical, emotional and financial harm that can be caused by medical devices that are defective.

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