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Textured Breast Implants Targeted by FDA Over Cancer Risk

Allergan and Other Cancer Risk Textured Breast Implants 

Medical implants are a common part of many surgeries that patients undergo. Implants can range from life-saving pacemaker’s that assist with a number of cardiac health issues to structural implants that help with broken or fractured bones. We use these implants with the assumption that the will provide a safe treatment of whichever health condition they are meant for yet many medical devices every year cause a number of health issues either because of their negligent design, manufacturing, or labeling. One of the latest products to cause some severe injuries to patients is textured breast implants. 

FDA Crackdown on Textured Breast Implants

The United States Food and Drug Administration has requested that textured breast implant manufacturers, Allergen, recall all of their textured breast implant products from the United States over concerns have been raised about the product’s ability to help cause cancer among the patients it is used in. Specifically, BIOCELL textured breast implant’s ability to cause breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The textured breast implant products that have been linked to BIA-ALCL Natrelle Saline-Filled breast implants, Natrelle Silicone-Filled breast implants, Natrelle Inspira Silicone-Filled breast implants, and Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants and have been marked for recall. In addition to these products, the recall also includes tissue expanders used by patients prior to breast augmentation or reconstruction, including Natrelle 133 Plus Tissue Expander and Natrelle 133 Tissue Expander with Suture Tabs.

Breast Implant-Associated Anaplastic Large Cell Lymphoma

BIA-ALCL is a very rare but devastating form of cancer that affects the immune system. Despite textured breast implants contributing to its development, BIA-ALCL is actually not considered a type of breast cancer. It is a form of T-cell lymphoma that occurs in the scar tissue that surrounds the textured implant and in more advanced cases, it may spread to the lymph nodes near the breasts. BIA-ALCL is typically treated through surgical removal of the breast implants and scar tissue. 

Risk Factors of Breast Implant-Associated Anaplastic Large Cell Lymphoma

The exact cause of BIA-ALCL is not known but it is believed that textured breast implants contribute to the development of this disease whether or not they are made with silicone or saline. It has been shown that textured implants may cause more inflammation than smooth inflammation. Some of the factors that are believed to contribute to the development of BIA-ALCL include reaction to implant particles, long-term allergies, genetic factors, or reactions to bacteria that grow on the surface of the implant.

Symptoms of BIA-ALCL

The symptoms of BIA-ALCL will take eight years on average to appear. The earliest symptoms have been reported to appear in two years. Symptoms of BIA-ALCL may include:

  • Redness
  • Swelling or fluid accumulation in the breast or around an implant
  • Changes in the shape or size of the breast or breasts
  • Lumps
  • Pain

The Damage Caused by BIA-ALCL Caused by Textured Breast Implants

The FDA has provided a new total of 573 individual cases globally of BIA-ALCL and 33 patient deaths which is a significant increase from the last reported update on the number of cases and deaths earlier this year. The increase was 116 new cases and 24 deaths indicating a spike in textured breast implant caused BIA-ALCL.

When someone suffers from BIA-ALCL they will typically have their entire life turned upside down. This illness causes slow destruction of a person’s immune system making them more and more susceptible to even the mildest of illnesses. On top of the pain caused by the cancer itself, people with BIA-ALCL will have to contend with a number of complications that arise from having a weakened immune system. The illnesses that can constantly plague a person have a way of wearing one down physically as well as mentally. 

Damages BIA-ALCL

The damages that are typically caused by a disease as potent as BIA-ALCL can consist of extensive medical bills for initial treatment, multiple doctor visits, medications, therapies, etc. that can recur long into the future to constantly drain a person’s finances. There is also the matter of how a disease like this affects one’s career. A person affected by BIA-ALCL will have a great deal of lost wages while they are unable to work. BIA-ALCL likely will impact their ability to even return to the same job that they once had since they may develop disability causing complications. Then there is the intangible damage of pin and suffering that a person with BIA-ALCL has to live with. Cancer tears apart lives, relationships, families, and even communities. The fallout caused by such a malady is severe and deserves to be compensated by those whose negligence contributed to it. Product liability claims give people that have suffered because of something such as textured breast implant caused BIA-ALCL the ability to seek compensation for the damages that they suffered. 

Contact a Clearwater Products Liability Attorney Today

There is nothing more discouraging than when what was meant to treat or cure a medical condition actually causes greater pain and loss. Few patients understand the weak regulations involving dangerous medical products and may make a decision regarding such without understanding the risks involved. If you have been injured by a medical product, you are entitled to the compensation you deserve to assist you in living life to its fullest. The attorneys at the Sibley Dolman Gipe Accident Injury Lawyers, PA have the experience you need to fight the medical corporations that are turning a fast profit at the expense of your health and well-being. Most corporations will make millions of dollars by rolling out an untested medical product before side effects and symptoms begin to develop in patients. They even anticipate this being the case. Don’t let them get away with it! Call our Clearwater office today at 727-451-6900 or contact us online for a free, no-risk consultation about your rights after a failed medical implant.

Sibley Dolman Gipe Accident Injury Lawyers, PA
800 North Belcher Road
Clearwater, FL 33765
727-451-6900

Product Liability