Boston scientific logo larger croppedJune 28, 2016, Mesh Medical Device News Desk ~ Boston Scientific Updates Warning in Pelvic Mesh Instructions

In a move that could be considered too little and too late – Boston Scientific (BSC) is updating the warning on its pelvic mesh products.   The news was announced in a Field Safety Notice  released by the International office of Boston Scientific, the Marlborough Mass.- based company.

Here is a Star-Tribune story on the same topic.

The notice also makes changes to the label on the BSC Pinnacle LITE pelvic floor mesh, not current available in the Boston Scientific U.S brochure,  but the label changes for the international community indicate it is still being used overseas. Boston Scientific surgical mesh made after 2012 may be made from counterfeit resin smuggled to the U.S. from China.  See the background here.

Boston Scientific is one of seven companies that is the subject of defective product litigation.  The company is facing 21,494 lawsuits among 93,000 lawsuits consolidated in West Virginia, as well as cases filed in state courts around the country and the world. Is is one of the few companies that is still marketing mesh used for pelvic organ prolapse (POP). BSC also makes mesh “tape” used to treat stress urinary incontinence (SUI).

BSC is adding more warnings and alerts to the Directions for Use (DFU), the label that accompanies the permanent polypropylene implants read by doctors, in case it is accused that the warnings are insufficient.

erosion and secondary infection

EROSION

While BSC and the other mesh makers long denied mesh erosion was a common occurrence, the new language now says that “regardless of the route of delivery” the pelvic meshes have been associated with “erosion.”

Erosion has been the most common complication of pelvic mesh and know about for decades, so this is not news to the women who have filed in excess of 21,000 product liability cases against the company in federal court in West Virginia.

Those defective product trials are full of cases of women suffering from erosion of all kinds as the mesh wears its way through the bladder, vagina, urethra, ureter and bowel.

Pinnacle pelvic floor kit brochure recalled by the fda

Pain by Jade R

Pain by Jade R

ADVERSE EVENTS 

Adverse events have been updated too.

They include perforation or laceration of vessels, bladder, nerves, urethra or bowel that can occur during placement of the mesh through the vagina.  Also listed as additional adverse events are scarring, scar contracture and ongoing chronic pain, an update from just the word “pain.”

These conditions may become permanent, says the press release.

The company has expanded those for whom the medical devices are contraindicated, in other words, patients the device shouldn’t be used in. That includes factors such as diabetes, smokers, age (whatever that means), pelvic floor radiation exposure, impaired wound healing, either from diabetes or steroid use, and an active infection near the surgical site.

What we have seen in mesh trials is evidence that mesh is not inert while in the body, it takes on a life of its own.  Once placed, pelvic mesh incites an inflammatory and foreign body response. Scar tissue forms and contracts oftentimes encapsulating nerves. This explains why so many women have pain that shoots down their leg.

The Directions for Use now say “scarring/scar contracture” can occur.

Explanted mesh.

Explanted mesh

 

PERFORATION

Perforating the colon can be a particular danger of vaginal mesh.  If used in the posterior space between the back of the vagina and the colon, polypropylene mesh can erode into the colon causing a septic condition. Sepsis is a severe and quick moving bacterial infection of the blood which originates in fecal material.

Many deaths have been attributed to sepsis that originated with perforation of the colon by mesh in both hernia mesh patients and women with pelvic mesh.

Now the instructions add “perforation or laceration of vessels, nerves, bladder, urethra or bowel may occur during placement.”  This is not entirely accurate because with time erosion into the bowel can occur.  Uphold

Boston Scientific continues to sell the Advantage and Advantage Fit System, the Lynx System, Obtryx and Obtryx II and the Solyx incontinence mesh placed through the obturator space.   Transobturator placement has already been found to be part of the defective design in the product liability trial of another manufacturer.

SLINGS AND KITS STILL SOLD EVEN THOUGH RECALLED IN U.S.

These devices are called Mid-Urethral Sling Systems, sometimes referred to as the innocuously named “tape” or “sling.”

The updated warnings also apply to the pelvic organ prolapse (POP) devices the company still sells overseas including Uphold LITE, Pinnacle LITE and UPsylon Mesh Kit. Most manufacturers have suspended sales of POP mesh since the greater amount of mesh appears to contribute to additional complications.

In the U.S.,  Pinnacle has been removed from the market. On May 10, 2011, Boston Scientific sent an “URGENT MEDICAL DEVICE RECALL-IMMEDIATE ACTION REQUIRED letter to all affected customers concerning its Class 2 recall for the Pinnacle Pelvic Floor Repair Kit because ‘”the device may exhibit low tensile strength between the needle and suture and led to needle detachment during mesh leg placement.”

Additions to POP mesh include that “mesh is considered a permanent implant. Removal of mesh or correction of mesh-related complications may involve multiple surgeries.”  Also warning is that the complete removal of mesh may not be possible and may result in additional surgeries.

We know from experience that repeated surgeries to try and remove mesh are not uncommon.

In its press release, Boston Scientific stresses none of these products are recalled and you need not return the product to the company. ##