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N.C. Judge Upholds Award of Summary Judgment to Boston Scientific on Failure-To-Warn Claim in Transvaginal Mesh Case
Jun 8, 2015 | HarrisMartin Publishing
A North Carolina federal judge has refused to reconsider an award of summary judgment to Boston Scientific Corp. in an Obtryx transvaginal mesh case, agreeing with the MDL court that the learned intermediary doctrine defeats the plaintiff’s failure-to-warn claim. -
Consider alternatives to risky transvaginal mesh
Jun 8, 2015 | Montgomery Advertiser
By Dr. Jefferson Underwood
It seems like every day there is a lawsuit for some form of medical product. Lately, if you have noticed, many lawyers are now advertising and soliciting for individuals who have had a transvaginal mesh implanted -
Despite warnings, mesh use for prolapse on the rise
Jun 8, 2015 | Urology Times
By Lisette Hilton
Despite the FDA’s warnings about health risks associated with the use of surgical mesh for transvaginal repair of pelvic organ prolapse (POP), use of the device is increasing, according to a study of POP patients in New York state. -
*New* Urogynecologist Dr. Walker Talks Mesh Removals and Worst Offenders
Jun 8, 2015 | Mesh Medical Device News Desk
By Jane Akre
Dr. Christopher Walker is a Urogynecologist located in Orlando, Florida. His practice focuses on urogynecology and female pelvic reconstruction. H
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Jun 8, 2015 | HarrisMartin Publishing
A North Carolina federal judge has refused to reconsider an award of summary judgment to Boston Scientific Corp. in an Obtryx transvaginal mesh case, agreeing with the MDL court that the learned intermediary doctrine defeats the plaintiff’s failure-to-warn claim.
On June 4, Judge Max O. Cogburn Jr. of the U.S. District Court for the Western District of North Carolina explained that the MDL court properly relied on the implanting surgeon’s admission that he did not read the device’s directions for use.
North Carolina resident Bertie Frankum was surgically implanted with the Obtryx Transobturator Mid-Urethral Sling System on ...
Subscription required, for full article please see: http://harrismartin.com/article/19578/nc-judge-upholds-award-of-summary-judgment-to-boston-scientific-on-failure-to-warn-claim-in-transvaginal-mesh-case/
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Consider alternatives to risky transvaginal mesh
Jun 8, 2015 | Montgomery Advertiser
By Dr. Jefferson Underwood
It seems like every day there is a lawsuit for some form of medical product. Lately, if you have noticed, many lawyers are now advertising and soliciting for individuals who have had a transvaginal mesh implanted. Before we talk about the complications of a transvaginal mesh, let's first understand what a mesh is and its intended use.
A mesh is defined as a barrier. It looks like a fishing net and is usually made of either metal, fiber or plastic. Meshes were first used in the late 1950s for hernia repairs. They were intended to hold back internal organs from bulging through the surgical incision after it was repaired.
Approximately 20 years later, surgeons, specifically gynecologists, started to use meshes to treat specific gynecological problems. These conditions were primarily pelvic organ prolapse, as well as stress urinary incontinence. Pelvic Organ Prolapse occurs when organs from the pelvis, such as the uterus, bladder or bowel, begin to push against the bladder wall due to weakened muscles. Usually, this occurs in females who have given birth, thus leading to weakening of these muscles. Stress urinary incontinence is when one has leakage of urine usually with increased physical activity from pressure being placed on the bladder. With stress urinary incontinence, you may find yourself leaking urine when you cough, laugh or exercise.
In the 1970s, doctors started placing a mesh in females to keep the pelvic organs from protruding through the vagina. The way this was done was transvaginally, that means implanted through the vagina. It was estimated at the height of its popularity, over 100,000 procedures using transvaginal implantation were being performed in the United States alone.
In 2008, the Food and Drug Administration took notice and reported about an increased number of adverse events most likely due to transvaginal placement of mesh. The most common complication noted was vaginal bleeding. Also, recurrence of prolapse and incontinence was occurring. All of these conditions, as you can imagine, can not only cause physical problems, but emotional problems as well. As a result, the FDA is now asking for careful consideration of other treatment options prior to the implantation of mesh transvaginally. This is because the mesh is a permanent implant and may not be able to be removed if complications should occur.
Some options are the ones that many doctors have been preaching for years. That is, weight loss and exercising, along with Kegel exercises, which may help improve stress incontinence. Also, reduction of the amount of liquid as well as avoidance of caffeinated products may be helpful. Studies have shown that weight loss has also reduced the amount of urinary incontinence episodes by an average of 10 per week.
When it comes to Kegel exercising, it has been proven to help strengthen the muscles of the pelvic floor and help reduce urinary leakage. Patients who tend to benefit the most are those under 60 years of age. In order for Kegel exercises to be effective, it is recommended to do at least 24 contractions a day for at least six weeks.
Other options before surgery is undertaken may not be as desirable. Some of these include the wearing of incontinence pads as well as electrical stimulation. Biofeedback using electronic devices or diaries may help some individuals. Other devices include a pessery which is inserted in the vagina. This device presses against the vaginal walls. Some people may benefit whereas others may not. Vaginal cone is another medical device with a string attached similar to a tampon. The contracting of the pelvic floor muscles will keep the cone from falling out, thus strengthening the vaginal walls.
Finally, there are a few other surgical procedures which one may consider as a last result. One such procedure is called a urethropexy. Urethropexy is the insertion of a sling through the vagina. This has a very low complication rate and takes about 25 minutes to perform. A sling is when the patient's own tissue or sometimes a synthetic material is inserted to help support the bladder and urethra, thus decreasing incontinence episodes. There are different types of slings. One is a tension free transvaginal tape, another one is a transobliterator tape. There is the readjustable sling and then there are a few others called the mini-sling and the needleless sling. All of these procedures should be discussed with either your gynecologist and/or your urologist who has experience performing sling procedures.
The bottom line is that before you run off and have any type of major procedure done, it is first best to try nonsurgical options.
Jefferson Underwood III, M.D., is a Montgomery physician.
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Despite warnings, mesh use for prolapse on the rise
Jun 8, 2015 | Urology Times
By Lisette Hilton
Despite the FDA’s warnings about health risks associated with the use of surgical mesh for transvaginal repair of pelvic organ prolapse (POP), use of the device is increasing, according to a study of POP patients in New York state.
At the same time, risks of reinterventions within 1 year and post-surgery urinary retention continue, said the authors of the study, which was published online in BMJ (June 2, 2015).
Researchers at Weill Medical College of Cornell University in New York analyzed a statewide database of nearly 28,000 women who had prolapse repair procedures in the state from 2008 to 2011. More than 7,300 women underwent prolapse repair with mesh and 20,653 had the procedure without mesh.
They found POP repair with mesh rose from 21% in 2008 to 30% in 2011. While more than 62% of the patients in the cohort were younger than 65 years, there were more 65-and-older patients in the mesh group than in the non-mesh group.
Although post-surgery complications were not common whether surgeons used mesh or not, researchers reported that mesh recipients were more likely than non-mesh recipients to have a reintervention within 1 year and to have urinary retention within 90 days.
In subgroup analyses based on age, researchers found that younger mesh patients had a 66% increased risk of reintervention within 1 year, compared to non-mesh patients. Mesh use was associated with a 36% increased risk of developing in-hospital complications, such as urinary retention, among older patients.
"This study is addressing the real-world, population-based application of mesh as a medical device, and it yields a different profile for its safety—that mesh is not as safe as people believe it is," said senior author Art Sedrakyan, MD, PhD, in a Weill Cornell news release.
Despite these findings, Dr. Sedrakyan and colleagues said, mesh is not always dangerous and these and other results should not be taken to the extreme.
But the FDA continues to send messages about mesh’s potential harm. The agency has issued proposals that would include the reclassification of surgical mesh used for POP from a moderate-risk to a high-risk, or class III, device.
“The authors present a manuscript which highlights the need and the benefit for patient registries for new surgical implants, such as what we’ve seen with the… POP mesh kits,” Daniel S. Elliott, MD, of Mayo Clinic, Rochester, MN, told Urology Times. “This current large-scale problem that we are dealing with shows the need to change how new surgical products are introduced to the market by industry, and then readily accepted by many surgeons and implanted in unsuspecting patients.”
While patient product registries help to fix the problem, they are not the entire solution, according to Dr. Elliott, who was not involved in the study.
“A registry occurs too late in the process to prevent complications. A registry only serves to alert the surgical community after the problem occurs,” he said. “My argument is that unless medical industry is forced to prove a product’s long-term safety prior to the release of a product (as with what occurred with POP mesh kits), then this whole mesh fiasco is doomed to be repeated. If the medical industry had been forced to definitely prove the long-term benefits of a new medical implant prior to release, and surgeons critically assessed all new products devoid of financial bias or incentive introduced by industry, then this whole POP mesh mess could have been avoided.”
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*New* Urogynecologist Dr. Walker Talks Mesh Removals and Worst Offenders
Jun 8, 2015 | Mesh Medical Device News Desk
By Jane Akre
Dr. Christopher Walker is a Urogynecologist located in Orlando, Florida. His practice focuses on urogynecology and female pelvic reconstruction. His HealthGrades link is here.Mesh News Desk editor, Jane Akre recently interviewed Dr. Walker who has patients from around the world visiting his Orlando facility to undergo mesh revision surgeries.
Currently he is doing about 30 to 40 a month. To make their trip as comfortable as possible, he has assembled a team to take care of flight arrangements, ground transportation and hotel accommodations. He has created an alliance with many surgical centers in an effort to decrease the patient’s bill and make the process of pelvic reconstruction financially feasible.
Dr. Walker spoke with Mesh News Desk editor, Jane Akre about his practice.
Q: Do you take insurance?
I take insurance. A lot of women do not have insurance and are suffering from complications which need a surgical intervention. We therefore have options for them to help them with their financial burden. My goal is to get them back on their feet and restore their lives.
Q: A lot of women are told by their doctors, they’ve never seen women with pain after a mesh implant – you’re the only one. Of course it’s impossible that they are the only one. There still seems to be a great deal of denial even among urogynecologists that a procedure could have gone wrong. Do you hear that?
I hear it all the time. I think the answer is two-fold. First, the ego of the doctor. He/she cannot fathom that a procedure they performed caused harm to their patients. The second factor of concern on the part of the physician is a potential malpractice claim against them as an individual. As a result of these two factors, some physicians defer the root cause of a patient’s symptom away from a defective transvaginal mesh product and link it to another diagnosis.
What physicians need to understand is that the problem stemmed from a defective manufactured mesh product and like an automobile with a defective transmission, such a product if proven to be defective, gets recalled. Many mesh manufacturers knew the design of the mesh had innate problems and instead of initiating a product recall, they continued to have physicians implant defective devices. Thus, physicians need to be transparent with their patients and admit the fact that they implanted with no mal-intent a defective product and then assist them to find the experts in the field available who can correct the adverse complications that may have arisen.
Personally, I always consider what I would do for my wife is what I would do for any patient. With that said I changed my treatment algorithm for pelvic organ prolapse. Instead of implanting a transvaginal mesh product as a first line option, I implant in over 97% of my patients a human biologic product and resort to a mesh option as my last resort and only in the right circumstances.
Q: What kind of injuries are you seeing and how has that changed in recent years, if at all?
The injuries I see are mainly centered around nerve injuries and the mesh product eroding into organs or becoming exposed in vagina. The result of the above is significant pelvic pain. The nerve related pain usually starts immediately post op or about 6 months to a year after the implant, when the product has scarred in and nerve entrapment occurs in the scar. Patients will often complain of having a persistent chronic pelvic pain which may radiate into the lower abdominal area or down the leg. They may also have lower back pain and sciatica. Patients will also state that they are no longer capable of engaging in sexual relations especially vaginal penetration. Some patients will experience an abnormal vaginal odor or discharge; incomplete emptying of the bladder resulting in symptoms of urinary urgency and frequency, recurrent bladder infections and having to void multiple times at night. Many will say they have to lean forward when sitting on the commode to empty their bladder.
Q: In your interview with Drugwatch I think you said you’re still using mesh?
In 99 percent of my patients I perform the reconstruction procedure vaginally using a human biologic tissue graft. As a last resort, I will use an abdominal approach to place a mesh product to address pelvic organ prolapse. The human tissue product comes from the dermis of a human donor. It is also used for burn victims and in breast reconstruction procedures. The FDA does not classify it as an implant but as a graft….. simply put it is not a permanent lifelong foreign body being placed in a patient’s body; after six (6) months the graft is replaced by the patient’s own tissue.
I take particular pride in ensuring I am not implanting a product that is being called biologic but was harvested from a pig (porcine) or bovine source since those products are also considered to be implants versus what I’m using which is considered a graft.
Q: Tell me more about the human graft that you use?
It is a dermal graft obtained from a cadaver- usually harvested from the side of the thigh or the back. Coloplast Corporation then processes the harvested product so that there is no risk of infection or any rejection of the tissue. It’s like a framework and six months after placement of the product it is replaced by the patient’s own tissue.
Q: What about harvesting fascia from the patient, in other words using their own ligaments?
If I am doing an abdominal surgery I will harvest some of the rectus abdominis fascia and use it as a sling. However, in most of my patients I perform vaginal surgeries and thus I use the grafts as I described before. In addition, by using the donor graft versus harvesting from a patient, it allows me the ability to make fewer incisions for the patient. Thus the recovery time is significantly less and patients are able to resume their lives much faster.
Q: What trends are you seeing in terms of mesh usage and complications?The trend I see is it’s becoming more prevalent. More and more people are now realizing this is the cause of their problem because of the World Wide Web, they are able to seek help and a lot of patients are coming in with complications.
Q: What I hear is some women are being told the lawsuits are lawyer generated as a way to discount them.
That is very unfortunate. In my opinion women who are truly suffering from the effects of defective transvaginal mesh products have no reason to lie and go through the arduous process of a lawsuit.
If they are faking their symptoms it will be quickly identified by an expert physician and the lawsuit will be dismissed.
In my personal experience I see on average 30-40 patients a month who present complaining of symptoms possibly related to a defective mesh product. Of that, less than one percent are faking it or they have symptoms that are not the result of the mesh product but are suffering from another condition such as diverticulitis, endometriosis etc.
So I strongly object to that statement and as an advocate for women, I implore them to seek expert help and get second opinions if they truly feel they may be suffering from complications related to a mesh implant.
Q: Have you notice patients reporting autoimmune complications among the others? I’d say two thirds to three quarters (who I talk to) have some autoimmune reaction. Have you noticed that?
I have seen it. It’s very interesting. Dr. Shlomo Raz in California (UCLA) presented his personal finding where some of his patients developed an immune reaction to polypropylene. Some of my patients upon presenting to me have already seen a Rheumatologist or an Allergist because they have generalized joint pains and a low grade fever. They may also complain of malaise and fatigue.
In some of my patients I have given them a course of steroids and I have seen an improvement in their symptoms- specifically relief of the joint pain or a low grade fever.
So with that said, I will like to see further research being conducted into this interesting finding by the medical community, major centers such as myself and others that have a high volume of patients who have mesh implants should collaborate and conduct a study to figure this out. My personal belief is that some patients do have an allergy to polypropylene.
Q: The TVT-O, has been found in a couple of courts been found defectively designed. Would you agree with that?
200 percent! It’s an innately bad product. What makes me sad is the manufacturers knew it was a bad product to begin with. The design in many ways was faulty. Everyone has a different anatomy. Therefore every pelvis is different …. So how can you design a trocar to be used for every patient knowing the exiting points of the trocar are going to vary?… sometimes the trocar will either hit a nerve or come in close proximity to a nerve. The inventor of TVT-O in his own paper expressed these concerns so why was it allowed on the market? In my opinion, that thing should be banned. If a doctor does not have the training to do the TVT retropubic approach, he/she shouldn’t perform that form of surgery.
They don’t need huge trocars going through multiple muscle groups. The TVT-O goes through four muscle groups and comes close to pelvic nerves. I have seen multiple cases involving mesh sling complications and in most the problem is related to the obturator approach which gives some surgeons the false hope that it has minimal complications. To the contrary the mesh arms become tight, nerves get injured at the time of the surgery or become entrapped, resulting in the patients suffering from pelvic pain.
The manufacturers tried to simplify the complex process of pelvic surgery so they could send doctors on a weekend course to learn on a cadaver and then practice on their patients. They don’t understand this nonsense should not be allowed. It is critical for surgeons to understand the complexity of pelvic anatomy and to be aware of the bio-mechanics of the available products on the market prior to attempting these forms of surgery.
Q: Which others are the worst offenders in your opinion?
All mesh kits with arms going through multiple muscle groups especially those that come in proximity to the sacrospinus ligament and pudendal nerves and vessels should be banned, every one of them.
The vagina is a clean contaminated area. If you put a mesh kit in the vagina, the mesh will be infected with bacteria resulting in a state of chronic inflammation arising over a period of six months to a year. This in turn will result in the mesh tightening decreasing its initial volume by 25-30% especially the mesh arms. The result is excessive tension on the genital tissue and pelvic pain.
If you are going to put in something with mesh, do it via an abdominal approach which is sterile- example a sacrocolpopexy. Of course it is still imperative in my opinion for any mesh product to be the last resort…. i.e use it when everything else has failed.
Q: How often do you have to put in a PP mesh?
I would say once every six (6) months.
Q: And that’s because her tissue is poor and she has numerous failures?
That is correct. So in my hands I have a treatment algorithm. I use physical therapy in my office for mild genital prolapse followed by the use of human biologic grafts and only as a last resort using some form of mesh implanted via an abdominal approach after giving informed consent to my patient.
I also offer my patients who are no longer sexually active the option of a Colpoclesis procedure which simply means- surgically closing vagina
Q: What I hear from some doctors is in the proper hands, the TVT still is a good option? Do you agree with that?
I don’t agree with it. Knowing what we have today, I would not implant that in my wife.
The absolute last resort should be any mesh product. I would like to suggest to my colleagues to look at the option of surgically placing a biologic sub-urethral sling using human tissue.
Truthfully the process of implanting a mesh sling is much easier and faster versus placement of a biologic sling. However, if we remember we took an Oath to do no harm….bearing that in mind I rather spend the extra time putting in a product that is best for the patient in terms of the potential adverse sequelae.
It’s important for us as a medical community to put patients first and treat them like your own family. Spend extra time in the room, give them an extra five minutes of our time. Some doctors are quick to send patients to the psychiatrist and pain management. Just pause, take and look and say ‘what would be done if this was my wife or my mother?
Q: Have you ever been a consultant, or a preceptor for any mesh maker?
Excellent question. I have never been a consultant for mesh. I was a consultant for Gynecare for their balloon endometrial ablation system known as the Thermachoice System. This system is designed to stop abnormal uterine bleeding.
Q: As you know, many members of AUGS (American Urogynecologic Society) serve in the capacity of being a consultant for mesh manufacturers
That’s correct… they are consultants for manufactures and we therefore have to be careful to interpret the AUGS position statement…. Which states that mesh is the Gold Standard in the treatment of stress urinary incontinence. Gold Standard is not a medical term when I was trained, we didn’t use that terminology, it’s a marketing term, and it’s an industry term. So the term Gold Standard should not even be used.
Dr. Dennis Miller, urogynecologist
Q: My question is how many members (of AUGS) have been polled for their opinion… But you’ve got Davila, Miller, Nager, Visco who are aligned with industry, who are also the people coming out with the position statement.
I can say that the AUGS position statement does not represent my opinion and that of many AUGS members. An exact number I cannot give you.
Further, it is my belief the term “Gold Standard” should be abandoned. Each patient needs to be treated individually and thus receive the best surgical option for her presenting complaint.
Q: Insurance is part of the problem isn’t it?
Insurance companies and managed care has been a source of the problem. It is unfortunate for Managed care not to understand the technical skill and experience required to remove a mesh implant and so they reimburse more to put it in a mesh implant versus taking it out.
That’s a problem… a surgeon can receive about $350 to take out mesh which can take sometimes 4 to 7 hours. Occasionally the mesh revision/removal surgeries have to be performed in multiple steps.
The answer is however simple…. When I ask myself what I would do if the patient were my wife/mother I resort to a biologic approach as my first line and I remember money is only a tool; God gave me a surgical talent and I try to serve him by helping my patients to the best of my ability. #
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