Allergan’s Failure to Warn on Breast Implant Lymphoma Delayed Diagnosis, Lawsuit Claims

Published on November 25, 2019 by Laurie Villanueva

A California woman claims Allergan, Inc’s failure to warn of a potential link between Biocell textured breast implants and anaplastic large cell lymphoma (ALCL) resulted in the repeated misdiagnosis of her cancer.

Allergan Breast Implant Allegations

According to a complaint filed in the U.S. District Court, Southern District of California, on November 1st, Misty Riportella received Biocell textured breast implants in 2000. At the time, she was not informed of the potential for breast implant lymphoma. (Case No. 8:19-cv-02103)

By 2011, Riportella was experiencing skin rashes, sore muscles, loss of energy, tingling and trouble breathing. Although she underwent numerous imaging scans, blood workups and other tests, doctors were unable to correctly diagnose her condition and attributed her symptoms to congestive heart failure, COPD, blood flow issues, and other problems.

In February 2019, however, Riportella’s daughter noticed swelling in her left breast. She was subsequently seen in the emergency room and referred to other specialists. That July, Riportella was finally diagnosed with breast implant-associated ALCL. Her Biocell breast implants and two lymph nodes were removed that same month, and she is currently awaiting a decision regarding further treatment for the disease.

“Plaintiff Misty Riportella’s case exemplifies what a manufacturer’s failure to warn the FDA and thus doctors of adverse events and associated risks of significant injury means in terms of a patient being able to obtain an accurate diagnosis,” the complaint states. “The saying, “time is of the essence” could not be more apropos then in relation to finding and treating cancer. Ms. Riportella was mistakenly diagnosed with a whole host of issues for years until ultimately she received lab results confirming the presence of Breast Implant Associated–Anaplastic Large Cell Lymphoma.”

Breast Implant Lymphoma

BIA-ALCL is not breast cancer, but a slow-growing form of non-Hodgkin’s lymphoma that occurs in the scar capsule that forms around breast implants. Symptoms typically include:

  • Lumps
  • Swelling in the breast
  • Asymmetry around the breast implant after the surgical site fully heals
  • Pain around the breast implant

The U.S. Food & Drug Administration (FDA) began investigating the link between breast implants and ALCL in 2011, and was already aware that the majority of cases involved women with textured-surface devices.

Earlier this year, the FDA confirmed that Allergan Biocell textured breast implants had been implicated in 80% of BIA-ALCL reports, as well as 12 of the 13 fatalities in which a manufacturer was identified. While Allergan agreed to recall Biocell textured breast implants and tissue expanders at the request of the FDA, the company has not taken any steps to compensate women who received the recalled implants.

Most women with breast implant lymphoma recovered after the devices were removed. However, those who experience a delayed diagnosis may need additional treatment, including chemotherapy and radiation. When deaths have occurred, the cancer diagnosis had been delayed.

 

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