Breast Implant Recall Lawsuit
Breast implant maker Allergan Inc. issued a worldwide recall on July 24, 2019 for textured models due to a link to a rare form of cancer. The U.S. FDA said that it called for the removal after new information showed Allergan’s Biocell breast implants account for a disproportionate share of lymphoma cases. The Allergan implant features a textured surface that experts feel contributes to the rare cancer. The FDA action follows similar recalls made in France, Australia, and Canada. More than 30 other countries recalled the Allergan product before the FDA acted.
The U.S. FDA announced on July 24, 2019 that it took “significant action to protect women from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).” The FDA requested that Allergan, which makes a specific type of textured implant, recall specific models of its textured breast implants from the U.S. market due to the risk of BIA-ALCL. The FDA said that following its request, Allergan notified the agency that it is moving forward with a worldwide recall of its BIOCELL textured breast implant products.
The Recalled Allergan products include:
- Natrelle Saline-Filled breast implants
- Natrelle Silicone-Filled breast implants
- Natrelle Inspira Silicone-Filled breast implants
- Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants
Related Allergan Products Recalled
The FDA said the recall also includes tissue expanders used by patients prior to breast augmentation or reconstruction. Those products include the Natrelle 133 Plus Tissue Expander and the Natrelle 133 Tissue Expander with Suture Tabs. The agency said the recall helps ensure that unused products are removed from suppliers and doctors’ offices. The agency also issued a safety communication on July 24 for patients with breast implants, patients considering breast implants, and their health care professionals. The communication outlined the known risks and the steps that patients should consider when monitoring for symptoms of BIA-ALCL, and it also lists information about all models and style numbers included in the recall.
Symptoms of BIA-SLCL include:
- Swelling in the breasts
- Lack of symmetry in the breasts
The FDA had ruled earlier this year that the implants could stay on the market. The FDA does not recommend that women with the implants have them removed if they are not experiencing problems.
Biocell implants feature a textured surface designed to prevent their slipping and to minimize scar tissue. Biocell models account for just 5 percent of the U.S. market. Most breast implants used in the U.S. have a smooth surface.
Allergan’s Textured Surface linked to Cancer
Health authorities first linked textured implants to cancer in 2011. The disease, however, is not breast cancer. It is lymphoma that grows in the scar tissue surrounding the breasts. It grows slowly and can usually be treated successfully by surgical removal of the implants.
Just two months ago, in May 2019, the FDA said that the danger did not warrant a national ban on the devices. But the FDA said on July 24 that new data show Allergan’s implants show a direct link to cancer, a link not seen with other textured implants.
FDA Deputy Commissioner Statement
FDA deputy commissioner Amy Abernethy said in a statement: “Once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action.”
FDA said the latest figures show more than 80 percent of the 570 confirmed cases of the lymphoma worldwide have been linked to Allergan implants. The updated figures reflect 116 new cases of the cancer since the FDA last released figures earlier this year.
An estimated 10 million women globally have breast implants, so the new numbers still reflect a rare disease, according to the FDA.
Breast Implant-Associated Anaplastic Large Cell Lymphoma
Nobody is sure of the disease’s exact frequency. The disease is known as breast implant-associated anaplastic large cell lymphoma. Published estimates range from 1 in 3,000 patients to 1 in 30,000 patients.
A researcher who has studied breast implant safety, called the removal of the devices inevitable: “Either the company would voluntarily decide to withdraw them from the market to protect from lawsuits, or the FDA would persuade Allergan to do so,” said Diana Zuckerman in an email.
In May 2019, the country’s three largest breast implant manufacturers – Allergan, Sientra, and Mentor – presented a unified on-point message to defend their breast implants. They told CBS News that textured implants have been extensively tested for safety, that they comply with FDA monitoring, that patient safety is their top priority.
Implants Fail ‘The Sister Test’
Breast surgeon Dr. Elisabeth Potter, however, told CBS News that she won’t use these types of implants anymore. She said they fail what she calls “the sister test”. If you wouldn’t give it to your sister, she said, you shouldn’t give it to your patients.
Instead of using implants, Dr. Potter now specializes in using a woman’s own belly fat to reconstruct a new breast. If a patient wants a non-textured implant, she’ll provide i. But she said, “The power [to choose] should be in the woman’s hands. Let’s give her the information and let her choose. (This) implant carries greater risk. Would you like it in your body? It’s that simple.”
Free Legal Consultation
Our law firm is nationally recognized for handling medical device litigation. If you or someone you love was implanted with a textured breast implant made by Allergan, contact our firm today for a free legal consultation regarding a potential breast implant recall lawsuit.