2002 Recalls and Safety Alerts: Released from PVC Medical Devices > No recall on breast implants with PVC, or polyvinyl chloride. DEHP

[Guest guest]

The good news is that some of the women have been receiving personal reponses from their Congressmen/women . . . Apparently Congress didn't know what chemicals are used in breast implants. . . Or maybe, with upcoming elections, they're trying to appear more responsive to the public.

Rogene

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Show #6, July 2002

Safety Assessment of Di(2-ethylhexyl)phthalate (DEHP) Released from PVC Medical Devices. http://www.fda.gov/cdrh/ost/dehp-pvc.pdf ...http://www.accessdata.fda.gov/psn/transcript.cfm?show=6 - 35k - similar

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Show #6, July 2002

Recalls and Safety Alerts

FDA is issuing a Public Health Notification informing practitioners and facilities about a possible hazard to patients when medical devices containing the chemical DEHP are used. DEHP is a common ingredient in plastics made of PVC, or polyvinyl chloride. DEHP acts as a softener to keep the plastic from becoming hard and brittle. Everyone is exposed to PVC plastic everyday and thus to low levels of DEHP. Of course these PVC plastics are used in many medical devices, such as IV bags and various kinds of tubing. Patients can absorb DEHP from some of these devices, and that's where the potential problem lies.The FDA notification explains that exposure to DEHP has produced a range of adverse effects in laboratory animals, but the ones of greatest concern are effects on the development of the reproductive system and normal sperm in young male animals. The

notification points out that there are no reports of these kinds of effects in humans, but there are no studies to rule them out. Two factors determine the degree of risk to patients. The first is the patient's sensitivity to DEHP. The FDA notification states that based on the animal data we just talked about, male neonates, along with male fetuses and males at puberty would appear to be the most sensitive groups. The second factor is the amount of DEHP received by the patient, and this is determined largely by the type of procedure performed.That being the case, the FDA compared the exposure to DEHP from various medical procedures, and identified several that would deliver the highest exposure to patients. These include exchange transfusion, ECMO, TPN when lipids are in a PVC bag, and enteral nutrition. The FDA notification recommends that when these high-exposure procedures are done on male neonates, male fetuses, and males at

puberty you should consider using PVC devices that don't contain DEHP, or using devices made of other materials than PVC, such as silicone, polyethylene or polyurethane. What about other patients, who are presumably at lower risk? For these patients, the notification states that the decision to use DEHP alternatives must take into account the medical advantages and drawbacks of the substitute materials, and their availability. The FDA notification stresses that high exposure procedures should not be avoided simply because of DEHP exposure. The risk of not doing a needed medical procedure would be far greater than the risk from DEHP.If you'd like to see FDA's complete safety assessment of DEHP, you'll find it on our web site.

Additional Information:

FDA Public Health Notification: PVC Devices Containing the Plasticizer DEHP. July 12, 2002.http://www.fda.gov/cdrh/safety/dehp.html

Safety Assessment of Di(2-ethylhexyl)phthalate (DEHP) Released from PVC Medical Devices.http://www.fda.gov/cdrh/ost/dehp-pvc.pdf