Allergan Launches Campaign Over Breast Implant Recalls

Allergan Launches Campaign Over Breast Implant Recalls

Introduction

The parent company of Allergan, AbbVie Inc., announced to launch a new awareness campaign to inform women implanted with their recalled Allergan Natrelle Biocell breast implants, who might be unaware of the risks associated.

The recall was a result of the link between Biocell textured surface design of the implants and BIA-ALCL, a type of non-Hodgkins lymphoma that may develop in the tissue surrounding the implant. Dozens of women nationwide have filed claims against the manufacturer, alleging that it intentionally covered up the problems and misled patients and the medical community.

According to a press release issued on June 1, the goal of the “dedicated multi-channel campaign” is to directly contact patients with Natrelle Biocell textured breast implants via digital and social media advertisements, which will lead those with the implants to visit www.BIOCELLinformation.com. The company states that this will help the consumers identify which implants they have and register them, which will, in return, help Allergan track the devices.

The announcement of the campaign will also be included on FDA's Biocell recall website. The federal agency also indicated that it will regularly monitor and assess the effectiveness of breast implants and will inform the public whenever new information becomes available.

On May 14, 2020, the FDA notified Allergan and Ideal Implant that the companies were unsuccessful to comply with the post-approval study requirements and procedures for reporting its user. Since the recall of the Biocell implant in July 2019, Allergan has faced hurdles in collecting data to track information of affected patients. Allergan revealed on June 1, 2020, that they failed to track the information of approximately 52,000 patients. 

Breast implants are used in both breast augmentation surgery (to increase the breast size) and in breast reconstruction (to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality).

Allergan Inc.’s breast implants include saline and silicone devices used in breast augmentation and reconstruction. The company is one of the largest breast implant manufacturers in the world and started selling breast implants in 2006. Allergan’s flagship breast implant brand is Natrelle, but it also sells implants under its subsidiaries Inamed and McGhan. The manufacturer received approval from the FDA on 11/17/2006.

Last year, all the breast implant products that featured the macro textured design used in Natrelle implants were recalled by Allergan as ordered by the federal regulators in the United States. The recall was announced by the FDA as all the reported cases of BIA-ALCL were linked to the design of the product.

The warning letter issued by the FDA indicated that the company agreed to conduct the study in October 2006 but failed to achieve it in the coming years. The company even failed to collect crucial data on safety endpoints such as long-term complications, connective tissue diseases, neurological effects, reproductive issues, lactation, suicide, and other issues, including cancer. Allergan was even supposed to collect complication data from physician evaluations on the product's completion of 1, 4, and 10 years.

As per the June 2020 Fortune article, women discovered about the breast implant device via news or social media. There were only a few who heard about the recall from Allergan or FDA. 

Senior VP of AbbVie and President of Global Allergan Aesthetics stated in the latest press release that they will leave no stone unturned to inform every woman about Biocell voluntary recall. Allergan will also educate women to know about their implant type and the level of risk associated with it. Allergan has partnered with the American Society of Aesthetic Plastic Surgery to work on major initiatives and raise awareness of breast implants. 

Allergan Biocell Textured Breast Implant products liability lawsuits are consolidated under MDL No. 2921. The litigation is presided by the U.S. District Judge for the District of New Jersey Brian Martinotti and the U.S. Magistrate Judge for the District of New Jersey Joseph A. Dickson.