US may lift ban on silicone Bulgarian airbags
FDA probes improved implants
The US may lift a 1992 ban on the use of silicone breast implants, allowing women to enjoy the "gummi bear" consistency sadly lacking in their saline replacements.
According to Wired, Canadian regulators last October cleared "for sale and implantation" cohesive silicone gel breast implants manufactured by Inamed and Mentor.
The US's Food and Drug Administration (FDA) is now pondering the matter. Press officer Heidi Valetkevitch said: "FDA is currently reviewing applications submitted by Inamed and Mentor for cohesive silicone gel breast implants. Canada's decision to approve standard silicone gel breast implants manufactured by Inamed and Mentor is consistent with FDA's determination in 2005 that these devices are 'approvable,' pending resolution of certain issues."
Quite what those pending issues are is not noted. The ban on silicone implants came as a result of health concerns, and according to this cautionary report on the BBC, the effects of a leak can be "dire". Christine Williamson, for example, "lost breast tissue, chest muscle and lymph nodes when her implant ruptured and had to be removed".
Saline implants, however, proved to be unpopular with users because of their "water bag" feel. Wired's reporter explains: "At the Plastic Surgery conference in September in San Francisco, implant makers displayed their wares in the conference's exhibition hall. To this reporter, the saline implant felt like a water balloon. The silicone implants displayed in the exhibit hall felt like a gel - a bit denser than hair gel."
To demonstrate the new, improved silicone implants' safety, one was duly sliced open. "The gel did not run out. It was sticky to touch but stayed in place," the reporter confirmed.
Which, as we all know, is not a proper test. We suggest fitting a willing volunteer with silicone Bulgarian airbags, putting her in a car and then crashing it at high speed into another vehicle. If the bags don't burst, we'll give them the thumbs-up. ®
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