Evaluating the New Mesh
The thousands of us who are injured can’t take back what happened to us and what our permanent health consequences of mesh products are. However, because I want this blog to be continuing education to inform all women of the issues of mesh BEFORE they undertake any pelvic surgery, I have spent time researching to find one of the so called NEW meshes that doctors are now recommending to women with statements such as “We don’t use THAT mesh”, when women question them about the current lawsuits and their concerns.
My research took me to a so called ‘new’ mesh product that was released according to their pamphlet on January 20th 2015. For me January 2015 means it is a NEW MESH implant they are using as of this year. However I believe by what I found out, that it is the same old mesh because I found the link to when this mesh passed through the FDA and it was in 2012. You will find that link at the bottom of this blog. I wonder how many women who will read this and have had complications from this mesh were ever told of the complications or given any such pamphlet. If you were one of them please use a fake name and leave a comment for other women to see.
I believe these new pamphlets are meant to cover the tracks with damage control because of continuing lawsuits. I am sure there must still be thousands these implant packages sitting on operating room shelves and women need to understand what this is all about. So I hunted and found a complete write-up about this implant product called Artisyn Y-shaped Mesh. Even though I am evaluated one type of implant, I want women to know that this evaluation is indicative to all ‘new’ mesh that is now on the market. I don’t care what the company behind the name is, you need to know that what I have been saying that MESH is MESH regardless of the brand, is my honest opinion and this article is proof of what I have been saying all along. I am also giving you a link at the bottom of this blog for another Y-shaped mesh implant made by Boston Scientific.
I am also going to do my best to decipher some of the medical language on this pamphlet that was provided on the same link and offer how I feel about it. I found the following information about this product on the Ethicon site owned by Johnson & Johnson and I will supply that link here. I am copying the entire article because once the word is out, these links tend to go away
Now read the full article.
The less mesh evolution. This short sentence is at the very beginning of their article which is obviously aimed towards surgeons. To me means this statement is saying they are using less mesh, but NOT no mesh. Let’s be clear it IS mesh regardless of how much is in a product. Now continue.
You understand that caring for your patients means using a mesh that complements your technique and her anatomy. ARTISYN Mesh, the only Y-Shaped Mesh designed to provide efficiency and support while evolving to leave less mesh behind (understand that this line says that mesh WILL be left behind according to their very own statement).127,142
For the Surgeon118,127
Support with Less Mesh
For the Patient118,127,142
Excellent Intra-Operative Handling
Unique Bi-Directional Design
- Mesh optimized to resist wrinkling and folding
So they knew about the problems with wrinkling and folding all the time. Resist means it may not happen, but it also means it COULD happen.
- Pre-creased vaginal flaps designed to reduce steps
Vaginal flaps designed to accommodate lengthening and disention
According to the dictionary, disention means strong disagreement; a contention or quarrel; discord. Or difference in sentiment or opinion; disagreement.
Sacral flap designed to limit elongation
So to help us understand ‘limit elongation’ means elasticity during stress and strain. So I suppose you should not do a thing after your implant or it will stretch and CAUSE complications.
Easy Mesh Placement
Tell that to someone who couldn’t pee at all after implant. Yes that’s me in March of 2010 after my implant surgery.
Mesh is Designed to be Strong
This must be where bench pressing comes in. (read further down on this blog about the things Boston Scientific wrote) I am not sure if weight lifters test it or who else does it but I am sure if they do they will experience stretching and elongation.
- Blue lines and orientation and visibility
- Sacral arm tapered to reduce trimming Wait what the hell does that mean? Trimming? I thought mesh implants are not supposed to be cut because that can cause problems.
- Strong mesh tear strength* So strong it is hell to remove and half your tissues will come away with it.
- Strong suture pullout strength in the sacral flap†
Precision During Fixation
Mesh Evolves Over Time
This is the problem with everything that doctors DON’T tell their patients and deny us when we complain of pain. Over time, in the human body mesh will not stay the same as when implanted.
- Blue lines facilitate accurate suture placement
- Large pore size makes suturing easy In past meshes everything has been blamed for complications from implants including hole size. The truth is mesh will eventually cause deep infection after being left in the body for a long period, regardless if it doesn’t happen at first or of the hole size.
- 46% of the mesh absorbs by 84 days. Is it absorbing in the blood stream, organs or where? No real answers of course so we are left putting two and two together and figuring out this is the problem with mesh because it causes immune complications, not just pelvic.
- Remaining mesh stays strong after tissue integration. There are other words for integration. Granulation is another. In other words it sticks to any interior body surface it can and becomes the same as scar tissue.
For the surgeon it offers EFFICIENCY According to my doctor it was a quick procedure and nothing to worry about. According to me, with my remaining complications, I am left to worry about it for the rest of my life.
- Excellent intra-operative handling with mesh optimized to resist wrinkling and folding and pre-creased vaginal flaps designed to reduce steps.
- Easy mesh placement with blue lines that aid orientation and visibility. The sacral arm is tapered to reduce trimming.
- Precision during fixation with blue lines to facilitate accurate suture placement. The large pore size makes suturing easy.
For the patient it provides SUPPORT WITH LESS MESH127,142
- Unique bi-directional design with vaginal flaps designed to accommodate lengthening and distention. The sacral flap designed to limit elongation.
- ARTISYN Mesh tear strength and suture pull-out strength characteristics are greater than or equal to that of Bard Alyte and Restorelle, Y meshes in benchtop testing.
Mesh evolves over time118,127,142
- 46% of the mesh absorbs by 84 days.
- Remaining mesh stays strong after tissue integration.
There was a link on this page for revised instructions posted on May 2015, so I clicked on it and a hard to read pamphlet came up. So I have taken care of that by changing everything so you can read it all without difficulty.
Instructions for Use For surgeons of course.
Please read all information carefully.
Failure to properly follow instructions may result in improper functioning of the
device and could lead to injury.
Federal (USA) law restricts this device to sale by or on the order of a physician. The ARTISYN™ Y-Shaped Mesh graft is intended for use only by physicians who are trained in the surgical procedures and techniques required for pelvic floor reconstruction (including abdominal sacrocolposuspension/sacrocolpopexy) and the implantation of synthetic meshes. The physician is advised to consult the medical literature regarding techniques, complications, and hazards associated with the intended procedures.
ARTISYN™ Y-Shaped Mesh is indicated for use as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy or laparoscopic approach) where surgical treatment for vaginal vault prolapse is warranted.
Mesh should not be used in infants, children, pregnant women, or in women planning future pregnancies, because the mesh will not stretch significantly as the patient grows. By this it is your fault if you accidentally get pregnant because they are saying “Don’t”.
Y-Shaped Mesh must always be separated from the abdominal cavity by peritoneum.
I am not a medical professional so my first thought was, what the heck is peritoneum? So I looked it up and this is what it is.
/ˌpɛrɨtənˈiəm/ is the serous membrane that forms the lining of the abdominal cavity or coelom in amniotes and some invertebrates, such as annelids. It covers most of the intra-abdominal (or coelomic) organs, and is composed of a layer of mesothelium supported by a thin layer of connective tissue. The peritoneum supports the abdominal organs and serves as a conduit for their blood vessels, lymph vessels, and nerves.
The abdominal cavity (the space bounded by the vertebrae, abdominal muscles, diaphragm, and pelvic floor) should not be confused with the intraperitoneal space (located within the abdominal cavity, but wrapped in peritoneum). The structures within the intraperitoneal space are called “intraperitoneal” (e.g. the stomach), the structures in the abdominal cavity that are located behind the intraperitoneal space are called “retroperitoneal” (e.g. the kidneys), and those structures below the intraperitoneal space are called “subperitoneal” or “infraperitoneal” (e.g. the bladder).
Here is an easier explanation of the peritoneum
While I was searching I also came across a cancer and that surprised me. This is that information.
Peritoneal cancer is a rare cancer. It develops in a thin layer of tissue that lines the abdomen. It also covers the uterus, bladder, and rectum. Made of epithelial cells, this structure is called the peritoneum. It produces a fluid that helps organs move smoothly inside the abdomen.
Peritoneal cancer is not the same as intestinal or stomach cancer. Nor is it to be confused with cancers that spread (metastasize) to the peritoneum. Peritoneal cancer starts in the peritoneum, and hence is called primary peritoneal cancer.
Peritoneal cancer acts and looks like ovarian cancer. This is mainly because the surface of the ovaries is made of epithelial cells, as is the peritoneum. Therefore, peritoneal cancer and a type of ovarian cancer cause similar symptoms. Doctors also treat them in much the same way.
Despite its similarities with ovarian cancer, you can have peritoneal cancer even if your ovaries have been removed. Peritoneal cancer can occur anywhere in the abdominal space. It affects the surface of organs contained inside the peritoneum. Read more on this link
More on the mesh pamphlet.
• ARTISYN™ Y-Shaped
or accidental opening of the gastrointestinal tract. Use in these cases may result in contamination of the mesh, which could lead to infection that may require removal of the mesh.
• ARTISYN™ Y-Shaped Mesh should not be used in the presence of active or latent infections or cancers of the vagina, cervix, or uterus.
• Patients who are on anticoagulation agents and undergoing surgery using ARTISYN™ Y-Shaped Mesh must have their anticoagulation therapy carefully managed.
• A digital rectal examination may be performed to detect possible rectal perforation. I can’t tell you how many women I know who have colon complications and this is where removing mesh gets very, very complicated. Urologists for the most part are not colon surgeons, so when they try to remove it, they do terrible damage to women. The only one I know who has any experience in colon surgery and is a urologist is Dr. Raz. Most doctors specialize in one area of the body and do not know enough to remove it from the colon and yet they don’t say that to women. They just get in there and try regardless of the consequences of what will happen to the woman. This is why many women lose their colons and some wind up close to dying from sepsis.
• Cystoscopy may be performed to confirm bladder integrity or to detect possible bladder or ureteral perforation. If you are a mesh injured woman, did your doctor tell you there was a chance for perforation of the bladder? Mine didn’t. Perforation of the bladder is so painful and it may need surgery to fix it.
• Postoperatively, the patient should be advised to refrain from intercourse, heavy lifting, and/or exercise (e.g., cycling, jogging) until the physician determines when it is suitable for the patient to return to her normal activities. I know women who after years began having terrible complications and had to give up their athletic careers because they can’t be fixed ever again.
• Use ARTISYN™ Y-Shaped Mesh with care, and with attention to patient anatomy and to proper dissection technique, to avoid damage to vessels, nerves, bladder, bowel, and vaginal wall. This line is HUGE for me and many women whose nerves were damaged by mesh at time of implant. No one told me that it could happen especially not my surgeon. Now I am disabled and I also know many women who are also messed up. So how much information about anatomy is enough when the procedure itself is flawed. There is no camera to see where they push a giant needle up through our delicate nerves and muscles. So how the hell do they avoid hitting nerves and muscles? Beats me.
• The safety and effectiveness of this product has not been validated in clinical trials. Now you know. There have never been any clinical trials done on women because once mesh has been placed in your body it has to be surgically removed if complications arise which can cause major injury. So no one has ever done clinical trials on humans and we women ARE the guinea pigs. This is why these products should never have been okayed by the FDA or other governments.
• Reuse of this device (or portions of this device) may create a risk of product degradation and cross-contamination, which may lead to infection or transmission of bloodborne pathogens to patients and users. Yes there was a big scandal about a doctor who was cutting up pieces of mesh and using them in other surgeries.
• Users should be familiar with surgical procedures and techniques involving pelvic floor repair and synthetic meshes before employing ARTISYN™ Y-Shaped Mesh. You know how they good at this? They practice on their patients after being shown how to do it, by drug manufacturer’s reps.
• Avoid placing excessive tension on the mesh implant during placement. Do you know how many women have told their doctors they can’t pee or having problems and the doctor goes back in to stretch it. Many I am afraid. Who is going to monitor this? Not the manufactures of course. They just sell them.
• This product should only be used under the prescription of a licensed healthcare practitioner. Why are mesh slings sold on EBay openly? Way cheaper than what is charged in operating rooms. Who is monitoring this?
• In patients with compromised immune systems or other conditions that could compromise healing, the risks and benefits should be weighed carefully.
I know women who had a high risk of cancer were implanted with mesh EVEN THOUGH the doctor knew of her risks. Mesh does compromise the immune system!
• Vaginal or urinary tract infection should be treated and alleviated prior to implantation. When you walk in a doctor’s office, for the most part they will do a dipstick test to see if there is any infection. Not every doctor will do a culture test because it is costly. It has to go to a lab and will grow whatever bacteria is in you but it takes about four days to get the results back. Without a culture, you don’t know what infection you have.
• Acceptable surgical practice should be followed for ARTISYN™ Y-Shaped Mesh as well as for the management of infected or contaminated wounds. If ARTISYN™ Y-Shaped Mesh is used in contaminated areas, it must only be with the understanding that subsequent infection may require its removal. I was never told this ever and from the moment it was put in my body infections took over. I was begging my doctor to remove it and in the end she removed a tiny piece from the center. Then I had to self-cath because I still could not pee.
• Prolapse repair may unmask pre-existing incontinence conditions. Be aware that many women find themselves with incontinence AFTER the sling has been put in them when they didn’t have it before.
• Prophylactic antibiotics can be administered according to the surgeon’s usual practice. Most of the time they write a prescription for Cipro, which can cause serious complications and allergic reactions. If you want to learn about antibiotics read this
• The use of this product with tissue adhesives is not recommended, as data are not currently available. PPE Specification Labeling Specification
8341745 ARTISYN Multilingual CE Marked IFU 100020719 | Rev:4 Released: 20 Jan 2015CO: 100277944 Release Level: 4. Production 3 ADVERSE REACTIONS
• Potential adverse reactions are those typically associated with surgery employing implantable materials of this type, bleeding including hemorrhage or hematoma, urinary incontinence, urge incontinence, urinary frequency, urinary retention or obstruction, voiding dysfunction, acute and/or chronic pain, wound dehiscence, nerve damage, recurrent prolapse, inflammation, adhesion formation, fistula formation, contracture, scarring and mesh extrusion, exposure, or erosion into the vagina or other structures or organs. You may not understand many of these complications but these are some of the complication blogs about them that I have already written.
Destruction of your bladder read this
They put mesh in this women knowing she had cancer. Read this
This is what will happen to your relationship when you can’t have sex. Read this
Now to continue with this pamphlet.
• As with any implant, a foreign body response may occur. This response could result in extrusion, erosion, exposure, fistula formation and/or inflammation.
They have been denying foreign body response all along, in fact lawyers are over-looking this because they say it can’t be proved. So what’s up with them? It says it right here by the people who sell it. You can’t imagine what has happened to women who deal with foreign body response. They are told they have Alzheimer’s and many have extreme problems with their thyroid.
• Potential adverse reactions are those typically associated with pelvic organ prolapse repair procedures, including pelvic pain or pain with intercourse, which in some patients may not resolve.
So now you know that you are at risk for never being able to have sex again if you choose to have an implant. Wonder what your partner would think about that and how so many injured women feel that have lost their partners when they couldn’t have sex. Read the link I already gave you.
• Dissection for pelvic floor repair procedures has the potential to impair normal voiding for a variable length of time.
Tell me about it. I know thousands of women who have forgotten what normal urination is like and they so wish they could take it back and many more do self cath. I am one of them and you can learn about it here
• Excessive contraction or shrinkage of the tissue surrounding the mesh, vaginal scarring, tightening and/or shortening may occur.
What they don’t tell you is what happens when shrinking occurs. PAIN! Not just pain but nerve and muscle damage.
• As with all surgical procedures, there is a risk of infection. As with all foreign bodies, ARTISYN™ Y-Shaped Mesh may potentiate an existing infection.
So let’s help the doctors tell their patients when they have infection after implant that there was an infection all along. Doctors love to tell you that YOU are the problem because you must have had an infection they didn’t know about. Not of course that it was the cause of mesh they implanted.
• Punctures or lacerations of vessels, nerves, structures or organs, including the bladder, urethra or bowel, may occur and may require surgical repair.
Did your surgeon warn you of this? I think not. This is because you would have RUN from his/her office and never have gone back because this is exactly what I would have done. They need YOUR business to pay their bills and won’t tell you any of this.
• Neuromuscular problems, including acute and/or chronic pain in the groin, thigh, leg, pelvic and/or abdominal area may occur.
Okay I am going to say something bad. I would love to shove this statement on thick cardstock up my implanting doctor’s arse. (Okay I was born in England and that is how I say it) You know why? I begged her to believe my groin and leg pain was real and she dismissed me and told me I must have been like it before my surgery. Before my implant surgery, I was climbing ladders every day working on my house until the implant surgery but she would have none of it because she wanted to blame me.
• These adverse reactions may require surgical treatment.
May? Who are these people kidding? There is no repairing damaged nerves and muscles. You have to learn how to live with it and get a disabled parking permit.
• As with any surgery, one or more revision surgeries may be necessary to treat these complications.
One or more? Tell that to women who have had twenty revision surgeries.
• ARTISYN™ Y-Shaped Mesh is a permanent implant that integrates into the tissue. In cases in which the ARTISYN™ Y-Shaped Mesh needs to be removed in part or whole, significant dissection may be required. Intergrates means it will stick to your tissues and organs and getting it out is painful as hell.
OTHER ADVERSE REACTIONS
You don’t know what this is? I looked it up for you to get a good explanation although I knew what it was.
A seroma is a collection of fluid that builds up under the surface of your skin. Seromas may develop after a surgical procedure, most often at the site of the surgical incision or where tissue was removed. The fluid, called serum, doesn’t always build up right away.
• Adhesion formation
Otherwise known as SCAR TISSUE which may also have to be surgically removed and can cuase major pain and complications.
• Atypical vaginal discharge
I’ve had women tell me they smelled like rotting meat and they were scared as hell. It was infection in the mesh that caused an abscess and a heavy smelly discharge.
• Exposed mesh may cause pain or discomfort to the patient’s partner during intercourse
You think? Tell that to all the women whose doctors ignored mesh protruding from their bodies and said they couldn’t find anything wrong with them, after their husnad’s said something cut them when they tried to have sex.
Do you miss what I am missing? How do they die? Do you think any woman would undertake a mesh implant knowing she could die from it? Hell no! So where is the explanation of how they can die?
DESCRIPTION ARTISYN™ Y-Shaped Mesh is constructed with the same knitting construction and material composition as GYNECARE GYNEMESH M™ Partially Absorbable Mesh and manufactured from approximately equal parts of absorbable poliglecaprone-25 monofilament fiber and non-absorbable polypropylene monofilament fiber. The polymer of the undyed and dyed polypropylene fiber (phthalocyanine blue, Color Index No.: 74160) is identical to the material used for dyed/undyed PROLENE™ Polypropylene Suture material. Blue PROLENE™ Suture monofilaments have been incorporated to produce contrast striping in the mesh. Poliglecaprone-25 fiber consists of a copolymer containing glycolide and ε-caprolactone; this copolymer is identical to the material used for
MONOCRYL™ (poliglecaprone-25) Suture. After absorption of the poliglecaprone-25 component, only the polypropylene mesh remains. As a convenience to the healthcare practitioner, the graft comes prepared as a Y-shape for sacrocolpopexy procedures in the repair of apical vaginal prolapse. The vertical stripes on the sacral flap and the horizontal stripes on the anterior and posterior flaps help aid in positioning, trimming and suturing the graft.
PATIENT FACTORS Physicians should use their surgical experience and judgment to determine if ARTISYN™ Y-Shaped Mesh is appropriate for certain patients. Patient-specific factors may impair wound healing, which may increase the likelihood of adverse reactions.
Surgeons walk into an operating theatre and they use whatever implant is there, on the shelf purchased by hospital purchasing manager. This is abstract about other implants but the practice is across the board with all implants. Read this abstract to know the truth.
BACKGROUND: Vendors of hip and knee implants court orthopedic surgeons to adopt their products. Hospitals, which have to pay for these products, now court the same surgeons to help reduce the number of vendors and contain implant costs.
PURPOSES: This study measures the surgeon’s perceived alignment of interests with both vendors and hospitals and gauges surgeons’ exposure and receptivity to hospital cost-containment efforts.
METHODOLOGY/APPROACH: We surveyed all practicing orthopedists performing 12 or more implant procedures annually in Pennsylvania. The survey identified the surgeon’s preferred vendor, tenure with that vendor, use of the vendor during residency training, receipt of financial payments from the vendor, alignment of interests with both vendor and hospital stakeholders, and exposure and receptivity to hospital cost-containment efforts.
FINDINGS: Surgeons have long-standing relationships with implant vendors, but only a small proportion receive financial payments. Surgeons align most closely with the vendor’s sales representative and least closely with the hospital’s purchasing manager. Paradoxically, surgeons support hospital efforts to limit the number of vendors but report that their own choice of vendor is not constrained. The major drivers of surgeons’ alignment and stance toward cost containment are their tenure with and receipt of financial payments from the vendor.
PRACTICE IMPLICATIONS: Hospitals face a competitive disadvantage in capturing the attention of orthopedists, compared with implant vendors. The vendors’ advantage stems from historical, financial, and service benefits offered to surgeons. Hospital executives now seek to offer comparable benefits to surgeons. I found that information here
Now to continue with the brochure.
Animal studies show that implantation of GYNECARE
GYNEMESH M™ Partially Absorbable Mesh elicits a minimal to mild inflammatory reaction, which is followed by collagen tissue ingrowth through the mesh, thus incorporating the mesh into adjacent tissue. The mesh remains soft and pliable, and normal wound healing is not noticeably impaired. In GYNECARE GYNEMESH M™ Partially Absorbable Mesh implanted subcutaneously in rats, the poliglecaprone-25 copolymer is essentially absorbed within 84 days after implantation. The polypropylene portion is not absorbed.
In an animal model, excessive connective tissue deposition and deleterious scar plate formation did not occur. The mesh construction permits trimming of the implant without unraveling.
On the next blog I will provide you with an animal study so you can read about the inflammatory response but who are they kidding? I know for a fact the implant was done in animals for only a few hours.
PPE Specification Labeling Specification
8341745 ARTISYN Multilingual CE Marked IFU
100020719 | Rev:4
Released: 20 Jan 2015
Release Level: 4. Production
This is the direct link and it is where I copied and pasted this information.
I researched this mesh and found the filed document for this product on January 12th 2012. I now wonder how many women had already been implanted with this mesh and had no clue there could be complications. Now you know why I believe they are covering up with a new pamphlet due to all the lawsuits. This is that link
Boston Scientific also has a Y-Shaped mesh but did not go into specific details. However it mentioned in fine print that their results were due to bench testing. So I google how they bench tested mesh, but nothing came up. It seems to me these companies do whatever they wish and don’t disclose all that needs to be. This is
So are these so called newer mesh better than the older ones? I Googled and found this.
“Intra-peritoneally placed meshes are prone to complications like extensive adhesions leading to chronic pain and increased chance of intestinal obstruction, sinus formation, infection, enterocolic fistula, etc. In addition, there is no conclusive evidence to suggest that the newer mesh like expanded polytetrafluoroethylene (ePTFE) or acellular dermal matrices are better than the basic polypropylene mesh (Ramakrishna and Lakshman 2013). As our patient had a large composite defect, involving more than half of the anterior abdominal wall, a free flap was the only feasible option.
Writing this blog has raised my blood pressure because I was so pissed by the time I finished it. But I want women to know the truth. Please, please learn what is happening to women all over the world and say “No to mesh!” Now for the animal study. Read that here