Allergan Natrelle BIOCELL Textured Breast Implants and Tissue Expanders

Attorneys Assisting Victims Injured by Defective Medical Devices

Allergan Breast Implants Allergan breast implants are a type of medical device. They are placed under breast tissue or chest muscle to reconstruct or augment the breast. There are two kinds of implants: those filled with silicone gel and those filled with saline. Irrespective of their type, the thickness of the shell, the shape, the size, and the surface of the implant can vary. Recently, it has been uncovered that there may be a relationship between Allergan breast implants and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). This is a cancer found in the scar tissue and fluid next to a breast implant. When it is not diagnosed and treated right away, it may spread and become fatal. If you have developed cancer due to a breast implant, you should contact the seasoned Allergan breast implant lawyers at Moll Law Group. Billions of dollars in damages have been recovered in cases with which we have been involved.

Health Risks Associated with Allergan Breast Implants

Many people go through breast augmentations and reconstructions. Often, the breast implants used for this work are made of silicone, which in turn is made of silicon, oxygen, and other materials. Textured implants are implants that cling to scar tissue capsules. People who get breast implants need to go through regular visits with their plastic surgeon to make sure that the implants are working correctly.

Late in 2018, the FDA investigated and discovered that some textured breast implants were causing ALCL. It asked the manufacturer to recall the breast implants and tissue expanders because there were 573 people around the world who had contracted BIA-ALCL, and 33 people had died because of the implants. The manufacturer agreed and pulled the implants from the market around the world. It created a BIOCELL Replacement Warranty in 2019. This provides replacements for consumers with the affected breast implants — the brands McGhan, Natrelle, Allergan, and Inamed — but it does not provide assistance with surgical fees, which are expensive.

Symptoms of BIA-ALCL include pain and swelling in the breast, fluid buildup, lumps in the breast, misshapen or asymmetrical appearance, hardening of implants, redness, and inexplicable weight loss. Due to the potentially devastating health risks involved, a consumer should be extremely alert to any of these symptoms.

Product Liability Lawsuits

Allergan breast implant attorneys have filed product liability lawsuits in connection with the implants. According to one lawsuit, the manufacturer has known that there is a link between the implants and an increased danger of acquiring BIA-ALCL since 2011. The lawsuit further alleges that a long-term study was done, but the defendant failed to reveal to the public that there was a link between the implants and lymphoma.

If you were injured by an Allergan breast implant, you can sue the manufacturer for damages. Product liability lawsuits can be brought under theories of strict liability or negligence. With strict liability, you will need to show that the manufacturer sold a textured breast implant that was in some way defective, the manufacturer intended this product to get to you without alteration, and you were injured by the defective breast implant. Negligence will require you to show a duty of care owed by the manufacturer, a breach of the duty of care, causation, and damages. Our Allergan breast implant lawyers can help you identify the appropriate legal theory to support your claim.

Products can be defective in three actionable ways. They can be defective in terms of their marketing, manufacturing, or design. Marketing defects are often failure to warn claims. In these claims, victims will need to establish that the manufacturer knew or should have known that there were risks attached to using the breast implants, but it did not let consumers know about the risks.

In most product liability lawsuits, a victim pursues compensatory damages. These can include medical bills, the costs of future treatment, lost income and earning capacity, and pain and suffering. Punitive damages may be available as well if the defendant’s misconduct was especially severe.

Consult a Knowledgeable Attorney to Explore Your Options

If you were harmed by Allergan breast implants, you may be able to sue for damages. Moll Law Group represents victims nationwide who have been harmed by defective medical devices. Call us at 312.462.1700 or contact us online for a free appointment with our Allergan breast implant attorneys.

List of Affected Products (according to the U.S. Food & Drug Administration)

Allergan Natrelle Saline-Filled Breast Implants approved under P990074. The textured styles are listed below:

  • 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 approved under P020056. The textured styles are listed below:

  • 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. The textured styles are listed below:

  • Style 410FM
  • Style 410FF
  • Style 410MM
  • Style 410 MF
  • Style 410 FL
  • Style 410 ML
  • Style 410 LL
  • Style 410 LM
  • Style 410 LF
  • Style 410 FX
  • Style 410 MX
  • Style 410 LX

The 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)

For more information, visit www.fda.gov, and click here to learn more about the Natrelle BIOCELL recall.

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