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Rick Shapiro
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Boston Scientific Adds New Warnings to Surgical Mesh Medical Devices

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Boston Scientific Corp. is adding new safety warnings to the labels for its medical devices that are among the most heavily litigated: surgical mesh devices that are used to repair pelvic disorders in women.

The medical device manufacturer has faced thousands of personal injury lawsuits from women who claim they were injured when their devices and dangerous pelvic slings became infected, or eroded surrounding tissue. This week, Boston Scientific stated that it was adding ‘erosion’ and ‘ongoing pain’ to the list of warnings on the medical devices.


The new label will state that meshes and slings are considered to be permanent implants, and that removal can be complicated or impossible.

Transvaginal slings are commonly inserted to treat stress urinary incontinence. Surgical meshes are implanted to strengthen tissue in patients who suffer form pelvic organ prolapse.

The label changes affect five Boston Scientific brands of slings – Advantage, Lynx, Obtryx, Obtryx II and Solyx – and three types of mesh – Uphold LITE, Pinnacle LITE, and Upsylon Y.

As of May 2, 2016, the company was facing more than 35,000 product liability lawsuits related to the devices. Boston Scientific has been sued for flaws in design and manufacturing; failure to warn of known dangers; breach of warranty; fraud; and loss of consortium.

Our Take

There are many medical devices and related products coming onto the market every year. One of the common questions our medical device product liability lawyers hear about defective or dangerous medical products are: ‘I don’t know the name of the manufacturer of my medical device. Can I still bring an injury claim?”

Yes. That is a major reason why you should possibly contact a medical device personal injury attorney. He or she can obtain the medical records pertaining to the device and those records usually show the manufacturer, model and even the UPC sticker.

Just as importantly, product liability attorneys constantly share information about lawsuits and medical devices nationwide. We let each other know if there are any class action lawsuits ongoing regarding a certain device, or any mass claims for similar consumer injuries from a device.

This type of information sharing among experienced product liability/medical malpractice attorneys is very important in securing large settlements for clients. Those funds are critically important in assisting their recovery and making up for losses in wages that their injuries may have caused.