Sources: FDA [press release], ReWalk [press release]
quote: The sheer number of good things they have done
quote: Like delaying approval of life saving treatments for years?
quote: I. PleuraSeal to seal lung incisions was approved in the EU with minimal testing. Claimed to be superior tostitches in preventing air leaks and subsequent lung collapse, Pleuraseal was withdrawn worldwide after a USstudy showed that 3 times as many Pleura-Seal patients had air leaks as those with stitches.II. Trilucent breast implants were approved in the EU without human testing and implanted in more than 8,000women. After the soybean filler was found to break down into toxic compounds, causing rupture, disfigurement,and potentially cancer and birth defects, the implants were withdrawn.III. Stent grafts to repair aortic aneurysms made by many manufacturers were approved in the EU with limitedtesting. When US approval was sought, FDA found that many of the devices approved in the EU presentedsevere risks to patients, including blood clots, graft failure, and aneurysm rupture.IV. An elbow implant was approved in the EU after FDA told the manufacturer that it had been inadequately testedand was prone to fracture. Once marketed in the EU, many reports of implant fractures caused the manufacturerto withdraw itV. Cardiac constraint devices to treat heart failure were approved in the EU based on limited testing. Testing tosupport US approval showed that the devices were no better than prescription drug therapy, but subjected patientsto invasive surgery, a higher risk of operative death, and precluded necessary bypass surgery for some patients.VI. Over 160 injected dermal fillers containing poorly tested substances have been approved in the EU, causinghigh rates of disfigurement, nerve damage and severe allergic reactions.VII. The Pendra glucose monitor sensor, approved in Europe as the first noninvasive blood glucose monitoringsystem, was withdrawn after later studies showed that the device was inaccurate and failed to warn ofdangerous blood sugar levels.VIII. At least 12 PFO Occluders implanted in the heart to prevent strokes have been approved in the EU. Laterstudies conducted for US approval showed that that a PFO Occluder marketed in the EU is no more effectiveno more effective for stroke than blood thinning medications but, unlike blood thinning medications, cause heartperforation and other serious complications.IX. The CoSTAR drug-eluting stent, approved in the EU with limited testing, was withdrawn from the EU when astudy for US approval showed that patients more often need repeat procedures and suffered heart attacks withCoSTAR than another similar available stent.X. The Biofield device, claimed to detect breast cancer better than mammography was approved in the EU withlimited testing. FDA review showed that the company’s studies failed to demonstrate that the device did, or evencould, work. It was not marketed in the EU.XI. RoboDoc, a robotic device to drill the femur for hip replacement, was approved in the EU with limited data.Later studies showed that the device caused serious complications, including tendon rupture, nerve injury, andhip implant failure.XII. Zephyr, a valve implanted in the lung to treat emphysema, was approved in the EU to replace surgery. Alater study for US approval showed that Zephyr was no more effective than surgery, but resulted in more deathsand serious complications.