Allergan Breast Implant Recall
July 26, 2019
As many of you have heard, Allergan has issued a voluntary recall of their BiocellÒ. This was issued as a response to the Food and Drug Administration’s (FDA) research into what is known as Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) which it published on July 24, 2019.
In the report, the FDA found that the worldwide incidence of BIA-ALCL showed 573 unique cases and 33 related deaths. Of those 573 cases, 481 (84%) were attributed to Allergan implants. The studies have found that Allergan textured implants (BiocellÒ) are associated with a risk which is 6x the other manufacturers which are marketing in the US.
There are three main manufacturers of breast implants which are marketed in the US: Allergan, Mentor, and Sientra. Dr. Williams exclusively uses Mentor implants and tissue expanders. Dr. Williams has been monitoring this issue closely for the past 2 years when the American Society of Plastic Surgeons (ASPS), to which he belongs, started a task force to evaluate the safety of textured implants. A short time after the task force was started, Dr. Williams independently made the decision to stop using textured implants due to the concerns of the task force.
Below are some common questions that Dr. Williams is asked as well as a summary of the latest news from the major reporting societies and agencies.
Should I have my implants removed?
The FDA notes that women who have these implants but no symptoms, do not need to have them removed.
What symptoms should I watch for to see if I have a problem?
Common symptoms include breast enlargement, pain, asymmetry, lump in the breast or armpit, overlying skin rash, hardening of the breast or a large fluid collection typically developing after receiving an implant and, on average, after 8 to 10 years.
What should I do if I suspect my implants have a problem?
You should seek a consultation with a board certified Plastic & Reconstructive Surgeon. Dr. Williams and his staff are well equipped to answer any questions you may have.
Are there different types of breast implant removals that can be done?
Yes. There are various ways that surgeons can remove implants. In patients with suspected BIA-ALCL symptoms, Dr. Williams recommends an En Bloc capsulectomy. Please see the section heading Breast Implant Removal for a description.
Is breast implant removal and/or capsulectomy covered by insurance?
Generally speaking, implant removal must be medically necessary in order for a surgery to be covered by insurance. In addition, there may be various exclusions based on the insurance coverage you have. Therefore, if you choose to have your implants removed without a medical indication, then it will likely not be covered by insurance. It is best to seek a consultation with your Plastic Surgeon to determine if it will be covered.
Where can I find more information about BIA-ALCL?
The ASPS website has a wealth of knowledge about ALCL. Go to plasticsurgery.org/alcl for more information.
For more information regarding BIA-ALCL, or breast implants, or to schedule a consultation, call Peak Rejuvenation at (970) 259-5990.
(7/24): Allergan plc (NYSE: AGN) today announced a voluntary worldwide recall of BIOCELL® textured breast implants and tissue expanders. Allergan is taking this action as a precaution following notification of recently updated global safety information concerning the uncommon incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) provided by the U.S. Food and Drug Administration (FDA).
Excerpts contained herein. See link for full article.
(7/24) The U.S. Food and Drug Administration today took significant action to protect women from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) by requesting that Allergan, the manufacturer of a specific type of textured implant, recall specific models of its textured breast implants from the U.S. market due to the risk of BIA-ALCL. Following the agency’s request, Allergan has notified the FDA that it is moving forward with a worldwide recall of their BIOCELL textured breast implant products, including: Natrelle Saline-Filled breast implants, Natrelle Silicone-Filled breast implants, Natrelle Inspira Silicone-Filled breast implants, and Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants. The recall also includes tissue expanders used by patients prior to breast augmentation or reconstruction, including Natrelle 133 Plus Tissue Expander and Natrelle 133 Tissue Expander with Suture Tabs. The recall helps ensure that unused products are removed from suppliers and doctors’ offices. The agency also issued a safety communication today for patients with breast implants, patients considering breast implants and their health care professionals outlining the known risks and what steps patients should consider when monitoring for symptoms of BIA-ALCL, including swelling and pain in their breasts. The safety communication also lists information about all models and style numbers included in the recall.
Based on new data, our team concluded that action is necessary at this time to protect the public health. We will continue to monitor the incidence of BIA-ALCL across other textured and smooth breast implants and tissue expanders as well as other devices intended for use in the breast. If action is needed in the future, we will not hesitate to do what is necessary to protect patients.
In a table updated today on the agency’s BIA-ALCL webpage, the FDA provides the new total of 573 unique cases globally of BIA-ALCL and 33 patient deaths, which reflect a significant increase in known cases of BIA-ALCL since the agency’s last update earlier this year —an increase of 116 new unique cases and 24 deaths. Specifically, of the 573 unique cases of BIA-ALCL, 481 are attributed to Allergan implants. Of the 33 patient deaths the FDA is reporting today, 12 of the 13 patients for which the manufacturer of the implant is known, are confirmed to have an Allergan breast implant at the time of their BIA-ALCL diagnosis. These cases include new data reported to the agency since the public advisory committee meeting in March. Based on the currently available information, including the newly submitted data, our analysis demonstrates that the risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately six times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S.
The FDA is continuing to evaluate these additional case reports and will make this information available on its database of adverse event reports within the next few weeks
This voluntary recall is a direct result of the agency’s comprehensive efforts to improve the quality of data collected and analyzed, and the FDA’s ongoing work to evaluate all available safety information.
“We understand that today’s news may be alarming to some patients with breast implants. In the safety communication issued today, we’re providing actionable information for individuals with specific breast implants and their health care professionals. The FDA does not recommend removal for patients without symptoms due to potential risks, but we provide helpful information for patients and providers to consider when discussing next steps,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health….We continue to advise women and health care professionals that the use of breast implants is associated with a risk of developing BIA-ALCL and that the risk is greater with textured implants.”
Textured breast implants overall are less common in the U.S. compared to other countries and specifically, macro-textured implants (the type of textured implant that Allergan manufactures) represent less than 5% of all breast implants sold in the U.S.
The FDA will continue to focus on gathering available evidence to help inform future regulatory actions and assure that women and health care professionals are informed of the risk of BIA-ALCL as they consider breast implants. To this end, the agency has requested that all breast implant manufacturers provide quarterly trending analyses of adverse events, including BIA-ALCL, and require reporting individual events in the adverse event database for devices and in existing registries
Plastic Surgery News (American Society of Plastic Surgeons)
International Society of Aesthetic Plastic Surgery
(7/24) We would like to inform our members that Allergan today voluntarily withdrew BIOCELL Textured Breast Implants and Tissue Expanders from the worldwide market. Effective immediately, healthcare providers should no longer implant new BIOCELL® textured breast implants and tissue expanders and unused products should be returned to Allergan. Allergan will provide additional information to customers about how to return unused products.
Thus, the breast implant manufacturer followed a request of the US FDA, which was based on new available data. It is emphasized again that there is still no recommendation to remove or replace textured breast implants from patients without symptoms. This global recall does not affect Allergan’s NATRELLE® smooth or MICROCELL® breast implants and tissue expanders.
(7/24) reports on Wednesday, Allergan issued “a worldwide recall of textured breast implants…after the Food and Drug Administration found a sharp increase in a rare cancer and deaths linked to the products and asked the company to pull them off the U.S. market.” The Biocell textured breast implants and tissue expanders “had already been banned or recalled in several countries.” According to FDA data, 573 cases worldwide have linked breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) to the devices since 2011.
New York Times
(7/24) reports that “the Biocell textured implants carry a risk that is about six times that of other textured implants sold in the United States, the [FDA] said.” The recalled implants may currently be used by “hundreds of thousands of women in the United States…Dr. Binita Ashar, director of the F.D.A.’s Office of Surgical and Infection Control Devices, said.”
Wall Street Journal
(7/24, Subscription Publication) reports that only a small share of breast implants sold in the US are Biocell textured implants, and that similar products carry lower risk for BIA-ALCL.
According to the AP (7/24), France, Australia, and Canada had ordered similar recalls. Meanwhile, “the FDA is not recommending women with the implants have them removed because the cancer is so rare, but say they should check with their doctor if they have symptoms, which include pain and swelling.”
(7/24) reports, “The FDA also announced that it is considering recommendations to change the labeling of breast implants to include a boxed warning indicating health risks, among other possible actions to help share safety information.”