Boston Scientific's NexStent Headache

Boston Scientific is once again the subject of bad news, as its NexStent medical device has been voluntarily recalled. The devices are used to treat a blockage in the carotid arteries, located in the patient's neck.

According to the FDA's recall notice, "The tip of the stent delivery system may detach from the delivery system during the procedure. This could lead to increased procedure time, cause vessel wall injury, stroke and/or emergency surgery to remove the detached tip." The FDA further notes that the recall does not include already implanted stents.

Of course, this leaves patients who received NexStents wondering if they really are safe from worry. After all, it's never good news to find out that a device that you had implanted, or something that was used to implant your device, has been recalled. So now, they are left asking whether every pain they have is related to a defective implantation device. They worry that pain in their neck, where the stent was implanted, was caused by the tip of the implantation device breaking off.

Patients who had NexStent implanted and suffered serious side effects after the fact may not have realized that the problem was with the stent's delivery system, known as the Monorail. Although no injuries have been reported related to the NexStent medical device, that does not mean that no injuries occurred, since many adverse events are not reported to the FDA.

One clue that a defective device was used in their surgery is that an additional surgery would have been required to correct the problem. So, patients who had the device break during implantation had to undergo additional surgeries, requiring further time off work and more recovery time.

This comes as even more bad news to Boston Scientific, who is currently waiting for the FDA to lift a two-year-old corporate warning letter. The letter cited "insufficient quality management practices and serious regulator problems at numerous facilities." The warning letter has prevented Boston Scientific from introducing new products on the market.

Last year, Boston Scientific agreed to pay more than $195 million to settle more than 4,000 claims against the company's Guidant Corp. defibrillators. The lawsuits alleged the defibrillators failed to work properly, resulting in shocks being applied when not necessary or life-saving shocks not being administered. Boston Scientific became responsible for the lawsuits after the company purchased Guidant Corp.

If you had a NexStent implanted in your neck and suffered serious adverse reactions, including injury to the carotid artery wall, stroke or unexplained pain in your neck, or if you required additional surgeries after the stent was implanted, contact a lawyer to discuss your legal options.