Allergan’s Game of Hide & Seek with the FDA

According to complaints filed by plaintiff’s attorneys, Allergan’s misconduct includes using a loophole in the FDAs reporting requirements to hide instances of serious injuries associated with its Biocell textured breast implants. More on that below.

Background on Cancer Linked to Allergan Biocell Textured Breast Implants

Allergan has been accused of failing to warn patients and concealing the dangers related to textured breast implants the company has marketed and sold since the 1990’s. Due to a defect in the “salt-loss” manufacturing process used exclusively by Allergan, the implants can cause chronic inflammation in the surrounding capsules leading to Breast Implant Associated Large Cell Lymphoma or BIA-ALCL. Almost all reported cases of BIA-ALCL have occurred in women who have Allergan textured implants. On December 12, 2019, the Judicial Panel on Multidistrict Litigation consolidated the cases filed against Allergan into MDL 2921.

Like all medical device manufacturers, Allergan has a duty to monitor, track and report adverse events to the U.S. Food and Drug Administration (“FDA”) so they are available to the healthcare community and patients. Allergan is required to formulate and execute a post-market surveillance plan for the purpose of ascertaining any issues regarding the safe and effective use of the textured breast implants once released to the market. They are also required to review and evaluate all patient complaints regarding the implants to determine if further investigation and testing are necessary.

Allergan’s Loophole: Alternative Summary Reports

Instead of protecting patients and living up to these expectations, Allergan did quite the opposite. Allergan is accused of intentionally hiding complaints from the public and the FDA by using Alternative Summary Reports (“ASR”) rather than the FDAs MAUDE database. The purpose of reporting adverse events is so the implants performance can be monitored over time to detect potential safety issues that can cause injuries to patients.

Prior to 2017, the FDA’s Alternative Summary Reports system (“ASRs”) allowed for multiple adverse events to be grouped together and filed as a single instance. Additionally, ASRs require much less detail with little or no narrative describing the problems. Allergan preferred using the ASRs system because the information is not publicly available or subject to public disclosure. However, ASRs were never intended to provide a channel for device manufacturers to bury important information about product defects.

By hiding important information through ASRs, Allergan could have misled healthcare professionals, patients and researchers about the type and severity of the issue associated with their Biocell textured breast implants, undermining patients’ decision making regarding their healthcare needs.

In 2017, the FDA shut down ASRs due in part to the abusive tactics of medical device manufacturers such as Allergan. Once ASR was no longer available, the number of breast implant adverse events sky rocked from around 200 per year to 4,567 in 2017 and 8,242 in just the first 6 months of 2018.

FDA’s MAUDE Database for Adverse Events

The FDA publishes adverse event reports for medical devices in its publicly available database known as the Manufacturer and User Facility Device Experience (“MAUDE”) which was instituted in 1995 and is updated monthly with new reports. Consumers, patients and medical personnel rely on the timely and accurate disclosure of this safety-related information in their healthcare decision making. Delayed or inaccurate reporting prevents the healthcare community and the public from knowing and understanding the risks associated with medical devices they may be considering.

Plaintiffs allege that Allergan neglected to timely report hundreds of known adverse events failing to divulge the risks associated with their textured breast implants. Allergan submitted reports under incorrect manufacturer names such as “Santa Barbra” and “Costa Rica” instead of using the name Allergan. In doing so, a database search for “Allergan” would not fully disclose the number of adverse events associated with their products. Allergan is further accused of burying evidence of implant ruptures and other injuries by reporting them to the FDA as “routine events” that did not require public disclosure.

This level of fraud and the injuries it can cause should not be tolerated by anyone!

Lymphatic Cancer Linked to Allergan Breast Implants

Women across the nation are filing lawsuits against Allergan Inc. claiming they have contracted a rare form of lymphatic cancer caused by Allergan’s BIOCELL textured breast implants. Plaintiffs are alleging that Allergan failed to warn doctors and patients of the increased risk of cancer and concealed known risks from regulators and the public.

Allergan uses a unique manufacturing process known as “close salt-loss texturing” in the production of its BIOCELL implants. Plaintiff’s attorneys claim the technique is flawed and creates defective implants with extreme texturing which can shred apart and leave silicone debris inside the body. When the body reacts to the silicone particles it causes chronic inflammation leading to a rare form of cancer known as Breast Implant Associated Anaplastic Large Cell Lymphoma or BIA-ALCL. In addition to cancer, many women have complained of fatigue, brain fog and other problems, collectively known as “breast implant illness.”

Many women choose textured breast implants because they provide a firmer feel than a smooth round implant. Texturing helps the implant adhere to the breast tissue which prevents rotation of the implant within the implant pocket.

Worldwide Recall of Allergan BIOCELL Textured Breast Implants

On July 24, 2019, Allergan announced a worldwide recall of their popular BIOCELL textured breast implants after the FDA determined that the medical grade implants may be linked to an increased risk of cancer. According to the American Society of Plastic Surgeons (ASPS), every confirmed case of BIA-ALCL has involved textured implants with the overwhelming majority being produced by Allergan. According to the FDA, out of the reported cases of BIA-ALCL, 84% were attributable to implants manufactured by Allergan Inc. While many BIA-ALCL cancer victims are diagnosed early and successfully treated, some women have died from the cancer.

About Case Works

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