New Breast Implant Recall in the EU Prompts Need for VeriTeQ’s Device Traceability Technology
VeriTeQ Corporation, a provider of implantable medical device identification and radiation dose measurement technologies, today commented on the latest breast implant recall in the European Union. Breast implants manufactured by French company Cereplas are being recalled by The National Security Agency of Medicines and Health Products (“ANSM”) due to concerns regarding sterilization and equipment used in production of the implants.
The ANSM in the EU has suspended the marketing, distribution and use of breast implants and sizers from Cereplas until the company achieves compliance with regulations, which include control of the process of sterilization and qualification of equipment used in production. Cereplas’ CE marking Certificates for its breast implants have also been suspended.
“This new recall of breast implants is the latest example of regulators pushing for higher standards for medical devices following the PIP scare in the EU,” said Scott R. Silverman, Chairman and CEO of VeriTeQ. “Furthermore, it serves as another reminder for manufacturers, physicians and patients of the need for advanced device traceability technologies like VeriTeQ’s Q Inside Safety Technology, that can externally retrieve the device information without the stress and risk of a re-operation.” VeriTeQ’s Q Inside Safety Technology acts as an electronic serial number in breast implants and other implantable and reusable medical devices to identify them during a recall or adverse event to help ensure patient safety.
VeriTeQ is currently working with breast implant manufacturer Establishment Labs, S.A. (“EL”), which markets its Motiva Implant Matrix® breast implants with VeriTeQ’s Q Inside Safety Technology in the EU. EL’s CE cleared Motiva Implant Matrix® product line with VeriTeQ’s Q Inside Safety Technology offers the world’s first externally identifiable breast implant.
By including VeriTeQ’s FDA cleared Q Inside Safety Technology in breast implants and other medical devices, manufacturers, physicians and patients will have access to a secure online database to retrieve device-specific data such as serial number, manufacturer name, date of manufacture, lot number, volume, size, and other data from the medical device manufacturer. Q Inside Safety Technology also provides an extra level of protection to the patient in the event of a recall or other safety event as it provides accurate and immediate confirmation of the origin of a patient’s medical device.