In July 2019, breast implant manufacturer Allergen recalled its Natrelle BIOCELL textured implants and tissue expanders.

The Food and Drug Administration (FDA) requested the recall due to the risk of a cancer known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) in patients with these implants.

Allergan Recall Overview

Following the FDA’s request, the voluntary Allergan recall was initiated globally. According to BreastCancer.org, recalls have been issued in 38 countries due to the possible link between breast implants and lymphoma.

At the time of the FDA’s first recall request, the agency had received 573 reports of BIA-ALCL worldwide and 33 deaths. Of the 573 cases, 481 were linked to Allergan implants. According to the FDA, the implant maker was implicated in 13 of the 33 deaths. Twelve of those 13 “were confirmed to have an Allergan breast implant at the time of their ALCL diagnosis.”

“Although the overall incidence of BIA-ALCL appears to be relatively low, 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 to alert the firm to new evidence indicating a recall is warranted to protect women’s health,” FDA Principal Deputy Commissioner Amy Abernethy said in a statement on the agency’s site.

Like most recalls, the Allergan breast implant recall aims to protect consumers from a dangerous product. Unfortunately, the recall may have come too late for some women.

In addition to the hundreds of patients who suffered from BIA ALCL after being implanted with Allergan products, three women died from BIA ALCL within a six month period that started only weeks before the recall announcement, according to Fortune. Even with constantly updated data from the FDA and other sources, there could have been unidentified cases of BIA ALCL which claimed the lives of women and went unreported.

Which Products Were on the Allergan Implant Recall List?

The Allergan recall list includes five different implants. The recall affects all lots of the listed implants made between July 2014 and July 2019. In the U.S., the recall includes nearly 250,000 implants. All of the recalled implants fall under the Natrelle BIOCELL textured product umbrella and include each of the following:

• Allergan Natrelle Saline-Filled Textured Breast Implants
• Allergan Natrelle 410 Highly Cohesive Anatomically Shaped Silicone- Filled Textured Breast Implants
• Allergan Natrelle Silicone-Filled Textured Breast Implants
• Allergan Natrelle 133 Tissue Expander with Suture Tabs
• Allergan Natrelle 133 Plus Tissue Expander

What Can You Do if You Are Affected?

Although the Allergan breast implants have been recalled by the company for their potential link with cancer, this Allergan recall only prevents new implants from being distributed. It has not been recommended that women who have these implants in their bodies already remove them. However, many women with the implants have reported feeling anxious or uncomfortable about keeping the potentially dangerous implants in their bodies.

According to the FDA, patients who haven’t experienced Allergan implant symptoms may not need to have their implants removed. This is due to the relatively low rate of BIA-ALCL among those with breast implants. However, there are warning signs and symptoms to watch out for, according to Cleveland Clinic, such as redness, pain, lumps, changes in the shape or size of the breast or breasts, swelling, or fluid accumulation near the implant.

If you have experienced any of these symptoms, you may want to speak to your doctor about your risk for breast-implant associated cancers.

Although Allergan has offered to pay for the costs of a new set of implants for women who currently have the recalled ones, the company has refused to cover the costs of removal. Women who wish to have their recalled implants removed will have to cover the costs of surgery themselves unless they have already been diagnosed with BIA-ALCL.

As breast implant surgeries are often not covered by insurance, many women may not be financially able to remove their potentially dangerous implants, as the surgery to remove or replace the implants may cost tens of thousands of dollars.

Many women who choose to receive breast implants do so after a double mastectomy or other breast cancer treatments, and this choice may be especially difficult to make. According to one woman who spoke to Buzzfeed News about her decision to get breast implants, “I had my breasts taken out for cancer. I didn’t want to put cancer back in.”

Other women who only have breast implants due to undergoing treatment for breast cancer have also reported being terrified to develop cancer a second time.

Should You File an Allergan Recall Lawsuit?

To ensure consumer safety, medical devices generally have to undergo a series of tests before being released on the market. However, sometimes dangerous or defective devices are still approved. Because of this, some consumers file defective medical device lawsuits against the manufacturers.

If your Allergan implants had to be removed or revised due to BIA-ALCL, you may be eligible to file an Allergan recall lawsuit to recover damages for your pain and suffering, lost wages, medical bills, and attorney fees. An Allergan implant recall attorney may be able to help you make a strong case.

Have Allergan Recall Lawsuits Been Filed?

A number of Allergan BIA-ALCL lawsuits have been filed. Two Florida women reportedly filed an Allergan lawsuit against the breast implant manufacturer in October 2019. The plaintiffs argue that they should not have to choose between increasing their risk of developing cancer and paying out of pocket to have their implants removed. They are seeking compensation for the cost of removing their implants.

The plaintiffs allege that Allergan sold a product that it knew or should have known posed a risk to consumers and that the company has unjustly profited as a result.

A similar suit was filed in August by plaintiffs seeking compensation for their implant removal and replacement. Allergan has also faced litigation from women who claim that their implants caused their cancer. According to MassDevice, two women filed an Allergan recall lawsuit in September 2019 blaming their BIA-ALCL on Allergan textured implants. Allergan has so far refused to pay for implant removal.

In March 2021, a New Jersey judge ruled that Allergan must face a class action lawsuit over its breast implants.

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This article is not legal advice. It is presented
for informational purposes only.