Boston Scientific Corp. is a named defendant in some 36,000 product liability lawsuits related to its surgical mesh devices, also sometimes referred to as pelvic mesh, pelvic slings or transvaginal mesh. These devices have been touted as a means to repair a host of pelvic disorders in women, but instead, they have proven extremely dangerous.
Now, the company is doing something it probably should have done long ago: Updating its safety warnings.
Of course, it shouldn’t take 35,000 lawsuits to prompt this kind of action from a pharmaceutical manufacturer, but better late than never. The question some people might have, though, is whether the safety warnings will have any impact on their ability to bring a civil lawsuit against the firm. The answer is probably not, so long as the surgery took place before the safety warnings were updated. Each individual case will be different, and there will be a lot of factors to consider, which is why we encourage anyone who suspects they may have suffered injury as a result of these devices to seek immediate legal counsel.
The problem with these devices, say the plaintiffs in the existing cases, is that they suffered injury when the mesh either got infected or eroded around the surrounding tissue. That not only results in horrendous pain and debilitating injury, it’s very difficult and in some cases possible to remove the devices.
So now, the company has vowed to add the words “ongoing pain” and “erosion” to the list of precautions and warnings that are on the labels for these devices, which are still available and still being used in surgeries worldwide.
The question will be whether future transvaginal mesh lawsuits involving surgeries undergone with this particular device after the warning labels were issued will be viable. The company is updating its labels because it will then be able to strike down the accusation that it didn’t warn doctors or consumers of the possible risks.
The new labels are going to indicate that the surgical devices are to be deemed permanent implants, which means that removal of them may not only be complicated but impossible.
The conditions for which these devices are usually implanted are:
- Stress urinary incontinence (slings);
- Pelvic organ prolapse (mesh).
Research conducted last year and published in the journal Obstetrics and Gynecology opined that women at risk for having surgery for any of the aforementioned conditions is about 1 in 5 by the age of 80.
Both the mesh and the slings made by Boston Scientific Corp. (a Missouri-based company) will have the updated label. The brands that will contain it include:
- Obtryx II
- Uphold LITE
- Pinnacle LITE
- Upsylon Y
These changes were unveiled in an “urgent” advisory memorandum issued in May to doctors across the globe.
It’s important to note: These devices aren’t being recalled. There was also no mention of sending the devices back to the company and the company was careful to say the advisory has “no impact” on devices previously planted, meaning they aren’t admitting liability for those past cases. Still, it’s likely to come up in future lawsuits. The company says it wasn’t swayed to alter the label because of the litigation, but rather because of new research out of Australia.
The company has thus far settled about 11,000 transvaginal mesh lawsuits, and there will likely be many more in the future.
If you are the victim of Massachusetts product liability, call the Law Offices of Jeffrey S. Glassman for a free and confidential appointment — 1-888-367-2900.
Boston Scientific Adds New Warnings to Surgical-Mesh Devices, June 15, 2016, By Joe Carlson, Star-Tribune
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Report: New Applications for Anticoagulant Medications – At What Risk? May 17, 2016, Boston Transvaginal Mesh Lawyer Blog