New Findings on Allergan BIOCELL: German Court Finds Lack of ALCL Warning

New documents from a U.S. court proceeding raise additional questions regarding the manufacturer's early knowledge and control over the BIOCELL surface.

Munich, August 27, 2026 - In a lawsuit brought by Patientenanwalt AG, a German regional court ruled that Allergan should have included a warning in its product information regarding a possible link between breast implants and anaplastic large cell lymphoma (ALCL). The relevant product information from 2011 did not contain such a warning.

The court found that a possible link between breast implants and ALCL had already been discussed in scientific circles and by health authorities since 2011. The Federal Institute for Drugs and Medical Devices had recommended to manufacturers--even before the relevant product information was published--that they highlight this potential link.

Nevertheless, the court ruled against the plaintiff in that case on liability grounds based on other factors, particularly those relating to the attribution of individual damages. The proceedings demonstrate, however, that the question of a failure to provide adequate information must be assessed independently of whether an affected patient has already been diagnosed with BIA-ALCL.

New Documents from the U.S.

This judicial assessment takes on additional significance in light of documents recently submitted in a U.S. class-action lawsuit.

The expert reports submitted in that case refer to internal Allergan documents and recorded statements by company employees. According to these, discussions within the company regarding a possible specific link between ALCL and the BIOCELL surface are said to have taken place much earlier than the company's public statements to date would suggest.

Additional documents pertain to the manufacturing process of the macrotextured BIOCELL surface. Among other things, they raise questions regarding

- loose or inadequately adhered surface particles,

- the control of the washing and brushing process,

- the existence of objective particle thresholds,

- the validation of the texturing process, and

- the biological testing of the finished textured implant surface.

These are not yet final judicial findings. The authenticity, specific product relevance, and legal significance of the documents must be examined in the respective proceedings.

Implications for German Allergan Proceedings

"The new documents are significant because they do not merely contain a retrospective scientific assessment. They refer to findings and technical investigations from within the manufacturer's internal operations," explains attorney Christian Zierhut of Patientenanwalt AG.

"In German proceedings, it will now need to be clarified when Allergan was aware of which product-specific risk signals, how the BIOCELL manufacturing process was monitored, and whether doctors and patients were informed in a timely and comprehensive manner."

In the opinion of Patientenanwalt AG, the investigation must not be narrowed down to the question of whether a patient has already developed BIA-ALCL. Specific implant-related complaints, capsular fibrosis, necessary revision surgeries, and mental health impairments may also be legally relevant.

No General Recommendation for Explantation

The new documents do not support a blanket medical recommendation to have BIOCELL implants removed as a precautionary measure. The medical assessment depends in particular on the implant type, symptoms, clinical findings, and the individual treatment situation.

Affected patients should retain their implant passports, surgical reports, informed consent documents, and available product information. If symptoms arise, a specialist examination should be conducted first.

Patientenanwalt AG is currently evaluating the new documents in connection with several German Allergan cases. Details regarding ongoing proceedings, clients, and the internal evidence strategy are not being disclosed to protect client confidentiality.

Further information:
https://patientenanwalt.de/allergan-implantate

Press contact:

Patientenanwalt AG
Attorney Christian Zierhut
Maximilianstrasse 33
80539 Munich
Web: https://patientenanwalt.de

Patientenanwalt AG
Maximilianstr 33
80539 Muenchen
Germany

https://patientenanwalt.de/allergan-implantate

Herr Chris ZIERHUT

Patientenanwalt AG - Specializing in Medical Law - Exclusively Representing Patients
In the area of product liability, Patientenanwalt AG has extensive experience from numerous cases involving defective implants and medical devices.

This release was published on openPR.