Defective Medical Device Lawsuit Ongoing

The recall of the defective medical device Allergan BIOCELL® Breast Implants and Tissue Expanders with texture follows a determination by the Food and Drug Administration (FDA) that certain types of textured implants may be linked to an increased risk of developing anaplastic large cell lymphoma (ALCL). Allergan has voluntarily initiated a global recall in order to ensure patient safety.

Textured Implants Increase the Risk of Large Cell Lymphoma

According to the FDA, women with textured implants with bumpy surfaces are more likely to develop ALCL than those with smooth implants. Regarding ALCL risk, the implant material does not seem to matter, whether it is silicone or saline. Women with breast implants, especially textured implants, have a higher risk of ALCL than those without. 

Accumulated Fluid Around the Implant May Indicate Problems

Although the risk of the disease is low, women with breast implants, especially those that are textured, do have a higher risk of the disease than those without. Years after the implant was placed, fluid collected around the implant (called a seroma) in most of the women who have been diagnosed with ALCL.The diagnosis was made in some instances by testing the seroma fluid. ALCL may also be diagnosed due to a breast mass or a tightened tissue capsule (capsular contracture) causing discomfort or cosmetic problems.

Which Implants Are Considered a Defective Medical Device?

Only the Allergan implants with BIOCELL texture are recalled, which include:

  • Natrelle styles 468, 363 and 168
  • The Natrell tissue expanders 133 that either have or don’t have suture tabs
  • The Natrell tissue expanders labeled 133 Plus
  • Textured styles of the INSPIRA® brand tissue expanders
  • Breast implants SoftTouch 410 and the McGhan and Natrelle 410

What Is the Incidence of Cancer Associated With the Breast Implants?

A growing number of cases and deaths associated with breast implants have prompted the FDA to recall them. According to the FDA, a total of 573 cases and 33 cancer deaths have been reported globally, 481 of which relate to Allergan BIOCELL implants. The focus by the agency when recalling the breast implants was the 33 deaths.

Of the 33 deaths, the manufacturer was known in 13 cases. Allergan manufactured the products used in 12 of the cases. The FDA identified the link connecting cancer and these breast implants in 2011. In addition, FDA has made an association with additional health problems associated with both smooth and textured breast implants such as rheumatoid arthritis, fertility problems and lupus. Other problems reported after women have gotten breast implants include autoimmune diseases, joint pain, confusion, muscle aches and chronic fatigue. However, no definite link has been established. 

Evidence Still Being Compiled in Defective Medical Device Case

On March 22, 2023, the FDA invited healthcare providers to submit any cancer diagnoses around breast implants to submit their data. Information on the effects of breast implants is being gathered and monitored. 

Olinde Law Firm: Defective Medical Device Lawyers

You can seek free advice from the Olinde Law Firm if you have been injured or developed cancer due to a defective medical device, such as Allergan breast implants. Call us at 1-800-587-1889 nationwide or 504-587-1440 if you live in the New Orleans area for a free case review. We are also available online. Our team is dedicated to working hard, so you receive maximum compensation for your injuries.