Collplant Biotechnologies Ltd. has signed a collaboration agreement with 3D bioprinting company Cellink AB for future commercial production of regenerative breast implants. Rehovot, Israel-based Collplant has developed prototypes of 3D bioprinted implants and is evaluating them in preclinical studies. The regenerative implants are designed to degrade over time and be replaced by new, naturally grown breast tissue. The technology aims to overcome the challenges of existing breast procedures that use silicone implants or autologous fat tissue transfer.
The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has issued an advisory regarding the risk of anaplastic large cell lymphoma (ALCL) in association with breast implants, but stopped short of recommending explant for asymptomatic patients.
The FDA has undertaken several new actions in connection with breast implants, including a new restriction on distribution to implant centers that review a pre-implant checklist with patients receiving implants. However, the agency has also mandated that manufacturers add a black-box warning of potential adverse events, such as the risk of developing anaplastic large cell lymphoma (ALCL).