FDA Issues A Warning Letter To Allergan Over Breast Implant

FDA Issues A Warning Letter To Allergan Over Breast Implant

Introduction

The U.S Food & Drug Administration (FDA) has issued a warning letter to Allergan, Inc., as the company failed to conduct post-approval studies on two different breast implant models, which were recalled last year over allegations that they might expose women to a rare form of cancer known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

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.

On May 14, the FDA issued a warning letter to Allergan as the studies on the recalled breast implants were necessary to be completed to assess potential long-term outcomes among women who are already implanted with the devices. Natrelle Silicone-Filled (Round Responsive) Breast Implants and Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants are the two Allergan products that required post-approval assessment.

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.

Allergan must respond to the letter within 15 days by providing a relevant plan to address the issues and violations. Apart from Allergan, even Ideal Implant Incorporated received a warning letter from the FDA over the same issue.

Currently, Allergan faces at least 50 lawsuits over breast implant cancer problems, which may increase gradually. All the breast implant lawsuits have been consolidated to form multidistrict litigation (MDL) before the U.S. District Judge Brian R. Martinotti in the District of New Jersey as it will prevent duplicative discovery and will result in a common outcome of the trials.