Lawyers for women with BIA-ALCL welcome Allergan worldwide voluntary recall
Lawyers acting on behalf of 13 women who have the breast implant related cancer BIA-ALCL have welcomed the announcement from the U.S. Food and Drug Administration (FDA) that it had requested that Allergan recall specific models of its textured breast implants from the U.S. market.
Posted on 24 July 2019
Lessons should have been learned by now... yet women are still finding themselves in a position where information which should be readily available to provide answers has not been there to protect them.”
Zahra Nanji, Leigh Day Solicitor
In a statement dated 24 July 2019, the FDA said that this was linked to the risk of women developing Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) from these types of implant. BIA-ALCL is not a form of breast cancer, but rather a form of blood cancer.
Following the FDA request Allergan announced a world-wide voluntary recall of their Biocell textured breast implants.
Zahra Nanji, from the consumer law team at Leigh day who is representing the British women who allege that their implants caused their cancer, said:
“We very much welcome this announcement from the FDA and the voluntary recall by Allergan of their Biocell textured breast implants.
“The scrutiny over the increasing reports of BIA-ALCL globally appears to be driving Allergan into action but we believe this should have happened sooner.
“It is very clear proactive collection and monitoring of breast implant data would ensure that issues with products can be spotted at the earliest opportunity, anything less is putting women’s lives in danger.
In their statement the FDA Principal Deputy Commissioner Amy Abernathy said:
“Although the overall incidence of BIA-ALCL appears to be relatively low, once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women’s health,”
In a press release Allergan said:
“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). BIOCELL® saline-filled and silicone-filled textured breast implants and tissue expanders will no longer be distributed or sold in any market where they are currently available. Effective immediately, healthcare providers should no longer implant new BIOCELL® textured breast implants and tissue expanders and unused products should be returned to Allergan.”
In a tables on the FDA BIA-ALCL webpage, the FDA reported that there are a new total of 573 unique cases globally of BIA-ALCL (481 are attributed to Allergan implants) and 33 patient deaths, 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.
Australian Therapeutic Goods Administration (TDA) announced on 11 July 2019 that that have written to a number of implant producers including Allergan and Nagor about its review and laboratory assessment of textured breast implants on the Australian market and their proposed regulatory actions to cancel or a proposal to suspend the use of these implants.
As of 3 May, the TGA had 78 cases of the BIA-ALCL reported in Australia, including four deaths.
The French National Agency for Safety of Medicines and Health Products (ANSM) announced on 4 April 2019 that it was issuing a macro-textured breast implant recall as a precautionary measure since cases of breast implant lymphoma have been overwhelmingly associated with textured breast implants.
The response of medical device agencies worldwide has therefore been proactive and it does beg the question as to what our own regulator the Medicines and Healthcare Regulation Authority (MHRA) are actively doing to ensure that issues with medical devices, including breast implants are picked up at the earliest opportunity.
The UK Cosmetic Surgery Registry was established in 2016 and is an opt in system. The data collected is unreliable in terms of identifying and spotting trends. The data the MHRA rely upon is inferior compared to other jurisdictions such as Australia who have an opt-out system which ensures more ‘active’ regulation and access to important data which can be monitored so that proactive steps can be taken to protect consumers. These concerns about yet another brand of implant once again highlights the need for proactive monitoring.
Ms Nanji from Leigh Day concluded: “Lessons should have been learned by now, especially following various breast implant scandals such ad PIP and Dow Corning, yet women are still finding themselves in a position where information which should be readily available to provide answers has not been there to protect them.”