Sometimes I wonder if doctors read. I realize they spend a lot of time taking care of patients, often seeing one right after the other to keep a healthy revenue flow. There is paperwork, expensive medical malpractice insurance and long hours. I respect the medical profession and count as friends a doctor or two. Then I get a note like this one and I have to say “Doctor, Duh!” What are you doing?
This woman writes to me and to Mesh Medical Device News Desk that she recently had a Monarc sling implanted, in fact just this month. Never mind that there are in excess of 19,000 lawsuits filed against the mesh manufacturer, American Medical Systems. and many of those defective product lawsuits name the Monarc. The transvaginal sling is used to treat incontinence (stress urinary incontinence or SUI) where the bladder or urethra sag a bit allowing urine to leak. Sometimes it’s put in prophylactically after a hysterectomy, “just in case” the woman experiences incontinence. As a result, women of all ages have been implanted with “slings” or “tape” made by seven manufacturers.
This woman is beginning to have pain. She wonders whether she will have a sex life again. She is in her 40’s. She is being advised to wait a bit as post-surgical pain is common, but still, she is beginning to worry. I tell her not to worry now, just be mindful, wait about six weeks as the doctor says to do. Maybe she will be one of the lucky ones. Mesh implants do work for the majority of women, maybe about 70%. At least in the short run. No one has studied why, when mesh goes wrong in a percentage of women, it goes very wrong.
I asked her, with all the information out there on social media at least (this site included), what was she told to convince her to take the chance?
The doctor, who is apparently very well respected, said her Monarc was not the mesh that was included in the lawsuits. Besides, his wife had a sling to treat SUI and she is fine.
Is he aware as of today there are 19,698 product liability/ defective product lawsuits filed against AMS? The company took its Perigee and Apogee off the market. The lawsuits do not distinguish between mesh for POP (pelvic organ prolapse) SUI (stress urinary incontinence) or between TVT (transvaginal tape) or TVT-O (transvaginal tape obturator). In other words, that doctor is not telling the truth.
See the So District of West Virginia (here) where the cases have been consolidated. Monarc is among those cases called a defective product. There are 75,000 lawsuits consolidated in this one federal court, more in one court than any other previous mass tort.
Were you told in two separate trials, (Linda Batiste and Jo Huskey) the TVT-O has been found defectively designed? These were meshes made by Ethicon, a division of Johnson & Johnson, but the TVT-O placement is virtually the same, passage through the obturator space a large space where your leg connects to the groin.
The TVT-O must pass through eight layers of muscle and tissue before it exits. When there are complications, as there are in about 30% of the cases, this is delicate surgery fraught with potential problems. Each layer has the potential to produce scar tissue which can shrink and contract, causing immense pain with every movement. Because it is nearly impossible to remove safely, the design of a TVT-O has been found to be defective.
The trials so far have shown us that manufacturers never prepared for that outcome, even thought it was likely it could happen. Early on, companies saw foreign body reaction, infection, chronic pain. They did nothing to address that, likely because it would have meant their product couldn't make it to market.
I asked her if she was told it’s made of polypropylene. Yes, she said. But polypropylene (PP) is not exactly a household name the public has heard such as cyanide, benzene, biphenols or formaldehyde. It’s polypropylene, most commonly seen as the material that makes up indoor-outdoor rugs.
Was she told a percentage of women are developing autoimmune issues following their implant? We know from trials that the body incites a foreign body response to mesh implants and among the results are fibromyalgia, rashes, joint pain, and lupus. Anecdotally, at least, there are more cases than could be considered a coincidence. Yet no one is studying the possible link.
Ask your doctor about his relationship with industry- is he a "preceptor" another word for teacher of other medical professionals. Does he consult and/or give lectures on behalf of the company? Is he paid to travel to nice places to attend weekend cadaver clinics where he can learn about the latest and greatest innovations in pelvic medical device implants? How much has he made from this relationship?
Why does he think AMS has put aside more than $1.6 billion, part of a master settlement to settle mesh-injury cases? See story here:
And despite the effective campaigns calling lawyers ambulance chasers and women looking for some justice a “payday,” these are real injuries causing chronic and debilitating pain, ongoing infections, an inability to function, to have sexual relations or to keep a job. Women are losing their income, their husbands and their homes. Many have expressed a desire to end this post mesh “life.” Women call me, as I display my phone on Mesh News Desk, and they often say the mesh implant was the worst decision of their life.
Your doctor is apparently caught up with the "good doctors don't have complications" mindset. Too often, a woman will not return to the doctor who is denying her pain is mesh-related. She seeks help elsewhere. The physician can then claim he doesn’t have complications, which is what he tells his patients.
Even the medical society, the American Urogynecologic Society, does not call the TVT-O the "gold standard.” That is reserved for the TVT, because at least it can be removed when complications arise. Why didn't he use a TVT? Is he able to do a Burch Procedure, which is using stitches to shore up the prolapse? What does he think about the Burch or about using your own fascia to create a biologically compatible sling?
Hopefully, she will be okay. University of California urologist, Dr. Shlomo Raz, long regarded as a mesh removal expert, says he is seeing mesh complications a decade or so after an implant. We really do not understand the long-term complication rate. We don’t understand how to safely remove mesh. Likely there is no such thing for many of these transvaginally-placed devices.
Were you told all of this as part of true informed consent?
Of course raising all this will set off your doctor. He will label you as litigious and will likely will turn you away as a patient.
Good luck. I do not wish you any complications but an easy outcome. I happens for many and I hope you are one of them.
I'm sorry you were not a truly informed patient. #