Since the July 2019 voluntary recall of textured breast implant Biocell, pharmaceutical company Allergan has been under fire. The recall came after research linked the implant with cases of breast implant associated anaplastic large cell lymphoma (BIA-ALCL). Allergan plans to launch a tracking campaign for U.S. breast implant patients in the near future.
Breast Implant Makers Issued Warning Letters by FDA
On May 14, 2020, the FDA sent warning letters to breast implant manufacturing companies Allergan and Ideal Implant. The companies failed to comply with mandatory post-approval study requirements and adverse event reporting procedures.
According to Binita Asher, director of the office of surgical and infection control devices in FDA’s Center for Devices and Radiological Health (CDRH), these studies are essential to ensuring the safety and effectiveness of the implants. In a May 2020 article entitled “Breast Implant Makers Land in Hot Water with FDA“, Asher says:
Post-approval studies are especially important to inform our understanding of the long-term potential risks associated with Allergan’s implants, including the models that have since been recalled from the market due to increased risk of breast implant associated anaplastic large cell lymphoma.
The manufacturer’s low recruitment and low follow-up rates for these devices is unacceptable.
Since the FDA’s warning letter, Allergan announced plans to launch a digital campaign to improve device tracking. The company also plans to contact individuals who have not yet been notified of the Biocell implant recall. A notice from the FDA sent on June 1, 2020, gives further campaign information:
Allergan Aesthetics will launch a multi-channel campaign which will include digital and social media advertisements further informing patients of the voluntary recall and directing them to Allergan Aesthetics’ www.BIOCELLinformation.com website for education on how to identify their implant type and register their implants.
Allergan’s Tracking Campaign
Since the July 2019 textured Biocell implant recall, pharmaceutical company Allergan has faced difficulties collecting tracking information for affected patients. On June 1, 2020, Allergan admitted they lack tracking information for some 52,000 patients.
According to a June 2020 Fortune article, many women found out about the recall via news reports or social media. Very few women heard about the recall directly from Allergan or the FDA. In addition, many are also critical of the assistance the company has offered to affected patients:
For example, the company has offered up to $7,500 to cover out-of-pocket surgery costs for any woman who has developed BIA-ALCL, and $1,000 toward diagnostic testing for anyone with the implants. But several affected women call those amounts inadequate for the costs of procedures that health insurance won’t always cover.
Carrie Strom, Senior Vice President of AbbVie and President of Global Allergan Aesthetics, addresses Allergan’s stance on the recall in a June 2020 WFMZ-TV article:
We are determined to make sure every woman has the information they need related to the BIOCELL® voluntary recall and we will continue to encourage women with breast implants to determine their implant type and opt-in to our device tracking system. Patient education is a priority. We have partnered with the American Society of Plastic Surgeons (ASPS) and the American Society of Aesthetic Plastic Surgery (ASAPS) on major initiatives to raise awareness regarding the importance of breast implant tracking.
Moving Forward: What Comes Next?
According to a June 2020 article for WFMZ-TV, Allergan Aesthetics is making effort to inform patients of the Biocell recall:
If patients are not aware of the BIOCELL® recall previously announced on July 24, 2019 and do not know the type of implant that they have in place or their implant history, they should either:
– Go to www.BIOCELLinformation.com to reach out to Allergan Aesthetics to determine if the company has their implant information.
– Contact their surgeon or hospital where they received implants to determine if the surgeon or hospital has records of their implant information.
Additionally, in the same June 2020 WFMZ-TV article, Allergan encourages patients to participate in device tracking measures:
Patients who know that they have an Allergan implant, and may not have participated in device tracking previously, or who need to update their information on www.BIOCELLinformation.com. The website will inform them how to register for device tracking, which is strongly advised for all patients, and answer any questions they may have.
As always, we will continue to monitor the worldwide issues surrounding breast implants and BIA-ALCL. We will provide you with any new or relevant information.
We encourage you to visit our Breast Implants Lymphoma Cancer page on our website for more information. Please submit a free case evaluation if you or someone you know has been diagnosed with BIA-ALCL.
Written by: Lauren Schwab, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.