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Companies often rush unproven devices to market using the FDA's 510(k) loophole. If your hip, knee, mesh, or catheter failed, you deserve compensation for revision surgery and pain.
*Revision surgery is often the primary qualifier.
Many medical devices are cleared for sale without rigorous human testing through the FDA's 510(k) program. This allows manufacturers to bypass safety studies if they claim their new device is "substantially equivalent" to an older one.
This loophole has led to disasters like the Metal-on-Metal hip implant failure and the widespread recall of defective hernia mesh. When these devices fail, they often shatter, migrate, or cause severe infection, forcing patients to undergo risky revision surgeries to remove and replace them.
Exactech polyethylene liners oxidizing/failing early.
Catheters fracturing and causing clots/infection.
Hernia & Transvaginal mesh causing perforation.
Foam degrading causing cancer/respiratory issues.
Tip: Keep your "Device ID Card" or medical records showing the specific model and serial number of your implant.
Settlements for defective medical devices are generally high because revision surgeries are complex, painful, and carry risks of further complications.
Device failure confirmed but surgery was minimally invasive or recovery was full.
Revision surgery required (e.g., knee replacement redo) with extended recovery/pain.
Catastrophic injury, multiple surgeries, permanent disability, or organ damage (sepsis).
Recall alerts and MDL court updates.
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