Breast Implant Lawsuit

Breast Implant Lawsuit
Filing a breast implant lawsuit may be an option for women diagnosed with anaplastic large cell lymphoma (ALCL) following breast augmentation or reconstructive surgery. In July 2019, the U.S. Food & Drug Administration directly linked Allergan’s Biocell textured breast implants to this rare cancer, resulting in their recall.

Other breast implant manufacturers are facing mounting lawsuits over “breast implant illness,” the name given to a group of debilitating symptoms reported in breast implant recipients.

Breast Implant Attorneys Now Evaluating Cancer & Illness Claims

Bernstein Liebhard LLP is now evaluating potential lawsuits involving breast implant cancer and breast implant illness. If you were diagnosed with ALCL following breast  augmentation or reconstruction surgery, or experienced symptoms allegedly associated with breast implant illness, please call (888) 994-5118 to discuss your case with a member of our legal team today.

FDA Confirms Breast Implant Cancer Risk

In March 2017, the FDA confirmed a small, but significant risk of anaplastic large cell lymphoma (ALCL) among breast implant patients, after logging more 350 reports of the cancer in patients with silicon or saline devices. At least 9 deaths were linked to the rare form of non-Hodgkin’s lymphoma.

By July 2019, the number of breast implant-associated ALCL cases had risen to 573, and included 116 cases reported since February 2019. The majority, 481, involved women who received Allergan’s Biocell textured breast implants.

At least 33 women died from the disease. The FDA was able to identify the breast implant manufacturer in 13 of those cases, 12 of which involved Allergan’s textured breast implants.

An FDA analysis concluded that women with Allergan Biocell breast implants were six times more likely to develop breast implant-associated ALCL compared to those who receivved other types of textured implants. Following a request from the FDA, Allergan agreed to a worldwide Biocell breast implant recall.

What Is Breast Implant Cancer?

ALCL is a cancer that affects the cells of the immune system. In breast implant patients, the disease is generally seen in the breast, usually in scar tissue around the device. However, ALCL can also occur in the skin or lymph nodes.

Symptoms of breast implant cancer can appear years after augmentation or reconstrution surgery. The FDA is advising women to monitor their breast implants and contact their doctors promptly if they notice pain, swelling or any changes in or around the device.

ALCL is treatable if detected early. Patients with a confirmed diagnosis of breast implant-associated ALCL should undergo implant removal and removal of the surrounding scar capsule, which is a more extensive operation than implant removal alone

Breast Implant Illness: What’s the Problem?

Silicone breast implants were brought to market in 1962, before the law required the U.S. Food & Drug Administration (FDA) to review and approve medical devices for safety and effectiveness. In the 1980s and 1990s, tens of thousands of women filed breast implant lawsuits for autoimmune and connective tissue disorders allegedly caused by leaking silicone implants. Eventually, Dow Corning and other defendants agreed to pay billions to settle the claims.

In 1992, the FDA imposed a near-virtual ban on silicone gel implants that lasted for 14 years. Since lifting the ban, the agency has only approved five silicone breast implants for use in the U.S.:

  • Allergan Natrelle
  • Allergan Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants
  • Mentor MemoryGel
  • Mentor MemoryShape
  • Sientra’s Silicone Gel Breast Implants

Since silicone breast implants were allowed back on the market, hundreds of women have  reportedly expeienced chronic fatigue, muscle pain, cognitive impairment and other debilitating symptoms after receiving the devices. This collection of symptoms has come to be known as “breast implant illness”

FDA Acknowledges Breast Implant Illness

The FDA convened a advisory panel meeting in March 2019 to discuss the risk associated with breast implants, specifically breast implant illness and ALCL. The women who spoke at the meeting asked that manufacturers be required to disclose the materials used in their breast implants. They also called for a Black Box Warning on the devices, and a few even urged the FDA to ban textured breast implants.

The FDA has so far been unable to establish a causal connection between breast implants and symptoms attributed to  breast implant illness. However, the agency did agree that evidence suggests some women experience systemic symptoms, including chronic fatigue, cognitive issues, and  joint and muscle pain, following breast implant surgery, which may resolve once the devices are removed.

In a statement, the FDA indicated it was considering several actions to ensure women and doctors are aware of the risks linked to breast implants, including a Back Box warning and requiring that doctors go over a checklist with their patients prior to surgery.

Filing a Breast Implant Lawsuit Can Help

Women who successfully pursue a breast implant lawsuit may be able to recover financial compensation for all of their injury-related damages, including:

  • Medical billse
  • Disfigurement
  • Lost wages
  • Emotional distress
  • Pain and suffering

If you or loved one were diagnosed with ALCL following breast implant surgery, or developed symptoms of breast implant illness, please call (888) 994-5118 to ensure that your legal rights are protected.

  1. FDA (March 2017) “Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)”
  2. FDA (March 2017) “Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)”
  3. Allergan (July 2019) “Allergan Voluntarily Recalls BIOCELL Textured Breast Implants and Tissue Expanders”
  4. FDA (July 2019) “FDA Safety Communication”
  5. PBS Frontline (N.D.) “Chronology of Silicone Breast Implants”
  6. The New York Times (1998) “Settlement on Breast Implant Claims”
  7. FDA (2017) “Silicone Gel-Filled Breast Implants”
  8. FDA (May 2019) “Statement from FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., and Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health on FDA’s new efforts to protect women’s health and help to ensure the safety of breast implants”



Last Modified: July 25, 2019

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