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Boston Scientific Bolsters Pelvic Mesh Warning Label

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. ##

 

20 Comments

  1. Janis Urban says:

    Doing the Smoker pitch again…I’m sure all 96K of us in the MDL are Smokers…Hell maybe the 100,000’s other women worldwide are smokers as well….Bastards! Now What? Where is the Test Results for the alleged counterfeit resin? It’s time to throw in the towel BS. Time!

  2. Jan B says:

    At the time of implant in 2010, non-smoker, non-drinker, fit, active, healthy, young (40), not diabetic, no infections, not overweight. Boston Scientific Lynx mid-urethral sling implanted for moderate SUI – immediate severe pain, became excruciating within 6 weeks, became life-threatening within 5 months. None of their “contraindications” applied to my situation, yet even after “full” removal of this horrible product, I have not been able to sit, work, or have sex since the day of the implant – and am likely dealing with these limitations for the rest of my life. If these products are allowed to remain on the market, which I strongly hope does not happen, companies should be forced to provide a warning to prospective patients similar to warnings on cigarette packages. The Boston Scientific Lynx midurethral sling warning should say “WARNING: 1 in 10 women who have this product implanted will find it eroding through their vaginas at some point in the future. Will have permanent, severe vaginal and urethral pain. Will likely require multiple surgeries to remove the mesh, but will be told it isn’t safe to fully remove it. Will likely never walk, sit, or have sex again – and will likely require pain management care for life. But at least they won’t leak when they sneeze!”

  3. Kitty says:

    All we can hope for is good strong lawyers that will fight for justice.

  4. John says:

    Why are they still being sold overseas? 1 word, bottom line… GREED!

    • Jane Akre says:

      That’s an excellent question. Because regulations there are more lax? Because there are few defective product lawsuits? Because in Australia and New Zealand, they make the taxpayers pick up the cost of catastrophic health outcomes left by medical device manufacturers…. Not even held responsible financially!!

  5. Linda W says:

    I had surgery in 2010, with the Solyx. And started having trouble about 7 or 8 months after surgery. Went back to my Dr. And he said that there was nothing else he could do and threw his hands up and walk out of the room. I have not had sex since before surgery.. Lost a relationship of 13 years. I have lost a lot of things because of this mesh, my incontience is so bad that I can barely go to the store and back with out ruining my clothe before I get back in the house, ( what a way to have to live). I have been to other Dr’s and they all tell me different things, one said I had a fistula,a tear by my vagina, also I went to a urogyncoglist and he Had to put me to sleep just to have and exam ( really) why would that be?) He said the mesh was so imbedded that there is no way to get this out. I will have to live with it. I have a lot of infections and I have chills every day, But the Dr’s won’t tell me why? I’m sick of this going on for 5 years and the courts let them get by with hurting all these women! I cannot comprehend whythiscannotbe settle? Boston Scientific is a in human organization to treat women this way?

    • Jane Akre says:

      Linda- Have you had any mesh removals or even an exam by an expert? There is usually something that can be done. You should not suffer this way. With a mesh removal and a sling made out of your own fascia, which could have been done in the first place likely, you could have a regular life perhaps. I dont know where you live but it would be worth an assessment…. let me know…

    • Bev says:

      Go see Dr Raz at UCLA. He will get all of out. Do allow anyone to do a partial removal.

  6. Louise says:

    Can’t believe they want to blame the people who smoke…ahahahahah…. what will they blame it on, next ? Come on, Boston Sci. you can make a better excuse, than that .You ‘ll do anything and blame anything, for you guys, not to take the blame on yourselves…lol…You’re all a bunch of TERRORISTS…You’re killing us…

    • Still Standing says:

      I am posting an article about post mesh complications. Actually, scientific research has shown that women who smoke have a higher risk of mesh erosion because smoking decreases the amount of oxygen the tissues need to be able to heal. While this has not been proven to be the main cause of erosion, evidence suggests that is it certainly a contributing factor. It can also contribute to device failure because smokers cough, which puts a strain on the pelvic repair. Im not making any judgments here at all, but just providing the scientic evidence that has been found. Here is the link.
      http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3644007/

      • Jane Akre says:

        Personally I believe adding mega doses of Vitamin C will help healing. 5000 to 6000 mg a day… You urinate out the excess

        • Still Standing says:

          Another vital component is proper pain management. Ive said this many times before, but pain causes us to brace, which tightens muscles and other tissue. They need oxygen to promote the healing process. Tight muscles carry less oxygen, and that results in poorer or prolonged healing. You need to use any and every way possible to reduce pain. It is just so important. In conjunction with that thought, the only time our muscles completely relax is while sleeping. If you have poor sleep, that will of course contribute to the healing prognosis. That is why you must look at every angle and address each component individually. Even small changes in one area can provide noticeablec benefits.

        • Still Standing says:

          Just one thing to consider, vitamin C is slightly acidic. Supplements may add ingredients that increase the acidity. This is not good if you have bladder issues, including utis, frequency, and IC. Just to be safe, It would be best to ask your treating physician if extra vitamin C would be recommended.

  7. Sheryl T. says:

    My journey with pain and tears began in 2010. Multiple surgeries and pleas for help and filed suit. No resolutions to any thus far. Praying for justice soon before my family and I lose everything. Please Judge Goodwin… please order these manufacturers to make it right for us before it’s too late as many of us can’t afford the medications and the surgeries we need and our families are suffering emotionally and financially as well.

  8. Margie B says:

    I had surgery in 2009. I have the bsc obtryx. In the last five years I lost my job. I am not able to sit without pain. I have not had a sexual relationship since the surgery due to pain. I have been told I have developed intercystial bladder. I have owned my home since 1997 and it is almost paid for but now I can not pay the note so it will go into foreclosure and i can not refinance because I don’t have a job. I applied for disability but it will take a year before the decision. I am so tired of the pain and incontinence and doctors telling me it can not be removed. When will the companies be held responsible. My attorney told me I would probably die before they settle these cases. I lost my partner and now my home I wish I was dead.

    • Jane Akre says:

      What a lovely uplifting thought from your attorney…… Geezzz.. Do you have access to experts who can assess your situation medically? Do you have the means to undergo surgery if it is suggested. You don’t say you’ve had a revision so please advise.

  9. Jo Sm says:

    Mesh for POP, several surgeries, first time involved scraping my bladder to get as much as possible off but not all. No sex, chronic pelvic pain, severe depression and now having pain in my legs that cause my legs to fold out from under me. I am very angry that they are still being allowed to to this to women!!! I am terrified to think about what my future holds.

  10. jan says:

    These manufacturers have altered woman’s lifes fir what reason other than pure GREED
    Woman need to stop being bullied by these manufacturers and fight
    The judges need to take hold and give harsh judgements on these manufacturers. . Yes,there should be limits but these manufacturers have mutilated these woman they will never be the same.. these women need real judgements
    They will never be the same
    These companies have made billions off these women. . These women should be getting MILLIONS it’s not going to break these companies. Maybe if there is a next time they will make something that is worth having on the market. .

  11. Barb says:

    I want to know what individual attorney o group is best to talk to about a suit? I definitely want to sue but don’t know who to go with. I don’t want to just go with whomever that don’t know what they are doing. I don’t want to just get a mesealy $40,000 that I’ve been hearing about. That’s just judges not truly taking this serious. I’m sick of male controlling attitudes still existing that go back to the stone age. Geez. What is it were your daughter, provided thy do love her enough to care. Oprah or other billionaires who want to good with their money could donate it to women in their fight against these big manufactures. We need to get a petition against the FDA for allowing mesh in the fist place. It is truly their fault as much as the manufacturer, especially to allow it to go on for as long as they have. They have allowed us women to be guinea pigs without our full knowledgeable consent.

    • Jane Akre says:

      Barb- let me know your manufacturer….. there are a few law firms remaining dedicated to individual manufacturers.

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