Boston Scientific Corp. (NYSE:BSX) issued an official statement urging the FDA to leave transvaginal mesh products under their current classification, despite growing concerns that the products do more harm than good.
Women's Health
Pelvic mesh panel convenes, Patient health records exposed online, SyntheMed and Pathfinder merge | MassDevice.com +3
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Update: FDA panel may bump transvaginal mesh up to high-risk without issuing a recall
An FDA advisory panel meeting yesterday and today may lean toward reclassifying transvaginal mesh products as Class III, the highest-risk category for medical devices, without recalling existing products.
FDA transvaginal mesh panel meets today | MassDevice.com On Call
MASSDEVICE ON CALL — An FDA advisory panel will meet today to discuss the possibility of putting transvaginal mesh products into a higher risk category, effectively pulling existing devices off the market until further testing can prove safety and efficacy.
The latest report from the watchdog agency’s Obstetrics & Gynecology Devices Panel recommended revoking 510(k) clearance for the devices, which are used to treat pelvic organ prolapse, over rising concerns that they may expose patients to unnecessary risk without offering clinical benefit above safer options.
Registries for breast implants?
I’m sorry I couldn’t attend the Food and Drug Administration advisory committee meeting the past two days that learned the two manufacturers of silicone gel breast implants — Allergan and Mentor — failed miserably in enrolling sufficient women for the required follow-up studies of their safety.
Stryker/Biomet’s rumored affair with SNN, massage strangler warnings, breast implants, the best of the summer, med-tech spending cuts and Stryker’s overseas efforts made headlines this week | MassDevice.com +7
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No recall for breast implants, BRIC markets go flat, Stryker acquires Concentric Medical for $135 | MassDevice.com +3
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No recall for breast implants, FDA says | MassDevice.com On Call
MASSDEVICE ON CALL — Despite warnings from advisory panels and pressure from consumer groups, the FDA announced that no recall would be issued for silicone breast implants.
FDA may revoke 510(k) clearances for transvaginal mesh products
Acquisition rumors for SNN by Biomet or Stryker, J&J under pressure to recall silicone breast implants, Medtronic and NuVasive rekindle patent spat | MassDevice.com +3
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Recall J&J breast implants, consumer groups tell FDA panel
Consumer groups asked the FDA to recall Johnson & Johnson’s (NYSE: JNJ) silicone breast implants over concerns that they haven’t collected postmarket data on the devices as promised.
JNJ’s Mentor division and Allergan Inc. (NYSE:AGN) won FDA clearance for silicone breast implants in 2006 on the condition that they would collect safety data on 40,000 patients for 10 years.