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Vertical Expandable Prosthetic Titanium Rib caudal rib supports
Hazard alert - risk of implant breakage that could cause adverse events and require additional surgery
Consumers and health professionals are advised that Johnson & Johnson Medical, in consultation with the TGA, is issuing a hazard alert for Vertical Expandable Prosthetic Titanium Rib (VEPTR) caudal rib supports used in rib-to-rib constructs. The sponsor is also recalling unused stock from specific lots supplied to date.
VEPTR caudal rib supports are implantable medical devices used to treat people with thoracic insufficiency syndrome.
It has been identified that these devices may have a hole at the end of the device that is only partially formed. If such a device is implanted in a patient and the construct is fully lengthened, it could result in the extension bar breaking.
If this occurs, the patient may experience pain, loss of deformity correction and/or injury. It could also result in the patient requiring additional surgery to correct the problem.
There are no confirmed cases of extension bar breakage directly related to a partially formed last hole on a VEPTR caudal rib support. However, since 2004, there have been eight cases worldwide of extension bar breakage after the construct has been fully lengthened that could be related to the above issue.
Please note that the hazard alert only relates to VEPTR caudal rib support implants and not VEPTR lumbar extensions.
Information for consumers
If you have had a prosthetic rib implanted to treat thoracic insufficiency syndrome, contact your surgeon or the hospital where the surgery was undertaken if you:
- experience pain
- experience loss of deformity correction
- have any questions or concerns about this issue.
Information for all health professionals
If you are treating a patient who has had a prosthetic rib implanted to treat thoracic insufficiency syndrome and who has any questions or concerns about the above issue, refer them to their surgeon or the hospital where the surgery was undertaken.
Information for surgeons and hospitals
Johnson & Johnson Medical has contacted surgeons who have implanted VEPTR caudal rib supports advising them of the above issue including procedures for recalling unused stock (contact Johnson & Johnson Medical on 1800 252 194 if you require the details of the affected lots).
Prophylactic removal of implanted devices is not recommended, as the risk of surgery may outweigh the benefit of continued treatment and monitoring of asymptomatic patients.
Potentially affected patients should be closely monitored. Frequent patient screening is part of the standard of care in the VEPTR treatment process.
When performing a lengthening procedure on a patient with an affected device, a decision to lengthen to a partially formed last hole should be based on the individual patient's circumstances, including consideration of the risk/benefit of utilising the last hole versus alternative options, such as revision to a larger construct.
If you have any questions or concerns about this issue, contact Johnson & Johnson Medical on 1800 252 194.
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.