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Boston Scientific 39 articles

Boston Scientific faces IVC filter injury lawsuit

A lawsuit alleging Boston Scientific didn’t adequately warn a man that its blood clot catching device could perforate a major vein in his body will move forward, an Illinois federal judge ruled. Willie Tyler filed a lawsuit against the medical device manufacturer alleging the company’s Greenfield IVC filter carried dangerous side effects. IVC filters are tiny cage-like devices that are implanted in the inferior vena cava, a large vein that carries deoxygenated blood from the lower extremities to the heart. The device is intended to catch blood clots before they reach the heart, which can lead to complications including pulmonary ... Read More

Transvaginal mesh maker accused of using counterfeit materials

Boston Scientific is adamant that it didn’t purchase counterfeit plastic materials from a Chinese supplier to produce its transvaginal mesh device for the treatment of pelvic organ prolapse. But a 60 Minutes investigation has uncovered evidence that suggests otherwise. CBS’s 60 Minutes reported that emails show the company knowingly bought the counterfeit parts from a Chinese supplier and even repackaged the material to hide that it was an imitation product. Boston Scientific and other manufacturers of transvaginal mesh devices have been caught up in massive litigation for years alleging the devices are defective and have caused women serious injuries from ... Read More

federal prosecutors are moving forward against alleged counterfeit transvaginal mesh

The Boston Globe reports that a criminal investigation against Boston Scientific has begun to get underway. This is different from the thousands of civil suits against Boston Scientific that are a part of the tens of thousands of transvaginal mesh lawsuits consolidated in multidistrict litigation (MDL) in West Virginia under U.S. District Judge Joseph R. Goodwin. The civil suits involve individual plaintiffs who are suing the respective manufacturers of transvaginal mesh devices for alleged complications such as infections, bleeding, severe pain and discomfort, urinary and fecal incontinence, erosion of the mesh into the vaginal tissue, organ perforation, and painful intercourse. ... Read More

Boston Scientific recalls 20,000 thrombectomy catheters

Boston Scientific Corp. is recalling more than 21,000 of its catheters used to remove blood clots during surgery due to reports of the devices breaking during procedures. The worldwide recall involves all models of Boston Scientific’s Fetch 2 Aspiration Catheter, a thrombectomy catheter used during procedures to remove small blood clots from the coronary arteries. The Food and Drug Administration (FDA) has classified the action as a Class 1 recall, reserved for devices in which use exposes patients to a reasonable chance of serious adverse health consequences or death. “There have been no reports of patient injury or death, and ... Read More

FDA notifies public, Boston Scientific may have used counterfeit raw materials in surgical mesh

The Food and Drug Administration wants health care professionals and patients to be aware that they are in the process of investigating allegations that Boston Scientific used counterfeit raw materials in its urogynecologic surgical mesh products. Additional testing is being done to determine if the mesh manufactured using the raw materials that have come under recent allegations is equivalent to the mesh originally approved by the FDA. The tests will also address the safety and effectiveness of the final product. The FDA anticipates these tests lasting several months and it will update its webpage with new information as it becomes available. It ... Read More

Stock analysis deems Boston Scientific transvaginal mesh allegations ‘quite serious’

Stock market analysis site Trefis.com, which helps people to understand how recent news might impact a company’s stock, says that the “Latest Allegations (against Boston Scientific are) Quite Serious.” The analysis refers to ongoing litigation surrounding the company’s transvaginal mesh products, which have been linked to serious complications and injuries. The U.S. Food and Drug Administration (FDA) issued a warning earlier this year that these devices, which are used to treat pelvic organ prolapse, are now considered high-risk devices. The FDA is requiring all manufacturers to submit a premarket approval application proving safety and effectiveness of the product. A future ban, ... Read More

Surgical guiding sheaths recalled due to design defect

Boston Scientific is initiating a worldwide recall of its UPN Chariot Guiding Sheaths used for the introduction of interventional devices during peripheral vascular procedures, because the shafts may separate, which may cause patient injury. Boston Scientific has received 14 complaints of the shaft separating, four of which involved the separation of the distal shaft. The separations occurred during device preparation or use. The most severe outcome was the embolism of device fragments, which could lead to obstruction of blood flow or additional intervention to remove a device fragment. Obstruction of blood flow can lead to injuries including stroke, kidney damage, ... Read More

Injuries, death linked to faulty guidewires used in heart procedure

Boston Scientific Corp. is recalling guidewire components for its Rotablator Rotational Atherectomy System used to open narrowed arteries and improve blood flow to the heart by cutting plaque from the artery wall, after receiving reports of the core wires cracking and separating from the rest of the system, causing serious adverse events including one death. The recall involves the RotaWire Elite Guidewire and wireClip Torquer Guidewire, components of the Rotablator Rotational Atherectomy System. Serious injuries reported include tamponade (blood in the sac around the heart causing decreased heart function), myocardial infraction (heart attack), and migration of wire fragments elsewhere in ... Read More

Bard ordered to pay $3.6 million over defective transvaginal mesh

C.R. Bard was slapped with a $3.6 million verdict in the first lawsuit to go to trial involving the medical device manufacturer’s allegedly defective transvaginal mesh. The ruling comes just months after the company agreed to settle thousands of other lawsuits from women who claim to have been injured by the transvagainal mesh. The jury had awarded the plaintiff in the case $5.5 million in damages, but the court slashed the award to $3.6 million after finding some fault with the doctor who had implanted the plaintiff with the company’s Avaulta transvaginal mesh. Transvaginal mesh, also known as bladder sling, ... Read More

Bladder sling market expected to grow despite safety risks

Transvaginal mesh, also called a bladder sling when used to treat stress urinary incontinence, has been linked to serious complications. Manufacturers have shelled out millions to settle lawsuits waged against them by women who claim they have been injured by the devices. But analysts say that the urinary sling market in the United States is expected to grow at a compound annual growth rate of 11.85 percent through 2019. The report published online at MedGadget.com covers the present scenario and the growth prospects of transvaginal mesh as well as male slings in the United States using in-depth market analysis with inputs from industry ... Read More