Allergan Textured Implants Recalls

SafetyWatch > Articles > Medical Device Recalls > Allergan Textured Implants Recalls

The United States Food and Drug Administration (FDA) asked for a voluntary recall of textured implants manufactured by Allergan on July 24, 2019. Allergan obliged and removed the implants listed by the FDA from the market.

In an attempt to rectify the situation, Allergan did offer to replace the textured implants, but stipulations apply. If a patient takes the offer, Allergan lays a contract in front of them, and they must sign the waiver releasing the company from further liability.

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What rights do these women have if Allergan blindsided them after the recall?

Why Were The Textured Implants Recalled?

The recalled textured implants have a link to breast implant-associated anaplastic long cell lymphoma (BIA-ALCL). The first case was reported in 1997 and grew to 573 unique cases in 2019. Of these 573 cases, 481 of them are linked explicitly to Allergan implants.

What is BIA-ALCL?

BIA-ALCL is short for breast implant-associated anaplastic long cell lymphoma. BIA-ALCL is a form of non-Hodgkin’s lymphoma, which is a cancer that affects the immune system. Although the origination of the cancer is in the breast, it is not considered a type of breast cancer.

Most cases of BIA-ALCL show the cancerous cells present in the fluid around the implant. The fluid is encased by the fibrous scar capsule and not the breast tissue. If BIA-ALCL goes untreated, it can cause the cells to spread. There have been at least 33 deaths associated with BIA-ALCL. Out of the 33 women, only 13 of their implant types are known.

Of the 13 women who died, 12 of them are linked to products manufactured by Allergan.

What are the symptoms of BIA-ALCL?

The main symptom of BIA-ALCL is painless swelling of the breast. Although this is something that can occur after the implant is placed, most cases of BIA-ALCL begin years after the implant procedure. Over half of the reported cases did not notice the changes until seven or eight years after initial implantation.

Other symptoms of BIA-ALCL can present as a mass in the area of the implant and pain in the implant area. Anytime that you are having problems with your implants, you should schedule an appointment with your doctor.

Treatment for BIA-ALCL

When BIA-ALCL has a definite diagnosis, and the protein CD30 is present in the fluid around the implant, surgery is an effective procedure. The scar tissue capsule and the implant get removed. Depending on the progression, more surgical procedures may need to be performed. Most plastic surgeons will wait another three months before addressing the possibility of reinserting a new implant.

Later stages of BIA-ALCL will require the same surgical procedures, but also the possibility of chemotherapy and radiation treatments.

93% of patients that undergo treatment report being disease-free by year three of diagnosis.

Allergan’s Response To A Recall

When the FDA released the recall notice to Allergan, they voluntarily complied with the recall. The company even went a step further to include replacement implants for those who are not symptomatic of BIA-ALCL. However, they will not cover the surgical costs. They state it clearly multiple times on their site and in their warranty that the FDA has said women who are not symptomatic do not require the implants removed.

The warranty that Allergan offers for their implants does acknowledge the BIA-ALCL possibility. The company will pay up to $1,000 for out of pocket expenses for those who have late seroma (the fluid around the implant) testing to diagnose BIA-ALCL.

For those who have a positive diagnosis of BIA-ALCL, Allergan will replace not only the implant but make the candidate eligible for up to $7,500 of financial assistance for out of pocket expenses, including surgery.

How much does breast implant surgery cost?

Breast implant surgery is considered a cosmetic procedure by most insurance companies, but that does not mean that some circumstances may apply where they pay some of the costs. If insurance does not pay anything, the surgery can cost close to $10,000. The price includes anesthesia, supplies, surgical room, etc.

This is a best-case scenario, too, it does not include complications. As you can see, Allergan’s financial assistance does not help with the entire bill.

Allergan’s Suggestion for Implants

Allergan’s pamphlet and fine print recommend that women who receive implants should have imaging done to check them after three years of having them inserted. Then they should follow up with imaging every two years after that.

Why Are Women Getting Them Removed?

Women, especially those who have already had breast cancer, are opting to have these implants removed and replaced. Even though Allergan is not covering the cost of the surgery, they are not comfortable keeping something in their bodies that could potentially cause them to develop cancer again.

Removal Story

Diana Cavallo received her first breast cancer diagnosis at the age of 44. She followed the recommended course of treatment and had a lumpectomy. Almost five years to the date, she was diagnosed with breast cancer again, at the age of 49. In 2010 she received her silicone implants. Six years later, Cavallo had her right silicone implant removed and replaced with a textured implant. She was told that textured implants adhered better to the tissue, which her silicone was not doing.

Then Cavallo started reading stories of the FDA issuing a recall on Allergan’s textured breast implants. When Cavallo had her textured implant put in, it was a Natrelle 410 Highly Cohesive Anatomically Shaped Silicone Filled Breast Implant, which made the FDA’s list.

After already beating cancer twice, Cavallo decided that she was not taking her chances with another type of cancer. She had the implant replaced with one that was not on the recall list.

Getting Legal Help Against Allergan

TorkLaw is now accepting cases from women and families who have been impacted by Allergan’s negligence. Allergan was aware of the BIA-ALCL that was possible with their textured implants, yet kept quiet about it. The company continued to sell and market these defective implants for almost a decade before the FDA had them recalled.

If you or someone you know has a legal case that needs to be represented, call TorkLaw today, and a staff member will assist you with your free, no-obligation consultation.

This content is informational only and is not legal advice. Please seek the advice of an attorney about your case.

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8 Cited Research Articles

  1. Questions and Answers About Breast Implant-Associated Anaplastic Long Cell Lymphoma. https://www.fda.gov/medical-devices/breast-implants/questions-and-answers-about-breast-implant-associated-anaplastic-large-cell-lymphoma-bia-alcl
  1. BreastCancer.org.  Special Report: Breast Implant Illness and BIA-ALCL. https://www.breastcancer.org/treatment/surgery/reconstruction/types/implants/special-report
  1. I Got Implants After Surviving Breast Cancer Twice-Then I Learned They Can Cause Cancer, Too. https://www.health.com/condition/breast-cancer/woman-removes-allergan-textured-breast-implant-fda-recall-bia-alcl
  1. UT Southwestern Medical Center. BIA-ALCL: 5 questions and answers about cancer linked to breast implants. https://utswmed.org/medblog/bia-alcl-breast-implants/
  1. American Society of Plastic Surgeons. BIA-ALCL Physician Resources. https://www.plasticsurgery.org/for-medical-professionals/health-policy/bia-alcl-physician-resources
  1. BIOCELL Product Safety Alert: July 24, 2019. https://www.allergan.com/medical-aesthetics/biocell-product-safety-alert
  1. Breast Implants. https://www.webmd.com/beauty/cosmetic-procedures-breast-augmentation#1
  1. Defective Breast Implants-Allergan Recall Lawsuits. https://www.torklaw.com/practice-areas/product-liability-lawyers/defective-medical-devices/defective-breast-implants-allergan-recall-lawsuits/
On This Page
  • What is BIA-ALCL?
  • What are the symptoms of BIA-ALCL?
  • Treatment for BIA-ALCL
  • Allergan’s Response To A Recall
  • How much does breast implant surgery cost?
  • Allergan’s Suggestion for Implants
  • Why Are Women Getting Them Removed?
  • Getting Legal Help Against Allergan

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