Coloplast Catastrophe

What do you know or understand about mesh implants? Have you been told by a doctor who wants to put an implant into you that he/she doesn’t use mesh, he/she uses silk? If so the implant is very likely to be made by Coloplast and you need to know it is MESH not silk.

If you read a document written by lawyers to take the manufacturer to court you will learn a great deal about what is used and what it is. I did exactly that to help women injured by this manufacturer. What will shock you is that in reading the document you would think that every woman would get at least one million dollars for all she went through. Not so. In fact this company did not go to trail and not one woman got to tell all that happened to her or collect proper and just compensation, because this company was much smarter. They just paid up without paying all the legal fees of a trial and they gave women a pittance. Read this.

Coloplast is a Denmark-based company that supplies “intimate health care products” — including catheters, ostomy bags, wound dressings, skin cleansers, antifungal products and vaginal mesh — to hospitals, retailers and directly to consumers in some markets. The headquarters is in Humlebaek, Denmark, with the U.S. headquarters in Minneapolis. The company employs 8,500 people in 55 countries.

Coloplast’s image took a hit in recent years due to litigation involving its transvaginal mesh products and reports of injuries caused by the implants. The company and several other mesh manufacturers face lawsuits in U.S. federal and state courts from women who report significant injuries from the devices. The total number of lawsuits is over 50,000, (It rose to 80.000) with Coloplast facing more than 1,200 in federal court and an unknown number in state courts.

In March 2014, the company settled 400 cases for $16.million amounting to $40,000 for each woman. The company has set aside DKK 1 billion ($186 million) to cover mesh lawsuits.

Business: Sells and markets a number of health products including catheters and transvaginal mesh.

2014 Revenue: $1.8 Billion

Popular Products: Restorelle Flat Mesh (transvaginal mesh implant)

Popular products? First of all what is Ristorelle flat mesh used as transvaginal mesh implants? By reading more, I gathered that this mesh is also used in hernia repairs on men and women.

Product description

Restorelle® products incorporate Smartmesh® technology in a full array of customized shapes and flat grafts. Smartmesh – a physiologically compatible, ultra-lightweight mesh.

Smartmesh technology provides strength while maintaining vaginal elasticity of natural tissue. The mesh is intended to be non-palpable to the patient and her partner. It is the first mesh designed by a surgeon, specifically with a woman’s anatomy and tissue healing requirements in mind. Note how terminology changes. Smartmesh?

Restorelle M and XL are indicated Sacrocolpopexy.

Restorelle® Smartmesh®

  • 99% cure rate (cf. 1)
  • 93.5% clinical cure rate transabdominally (cf. 4)
  • Vaginal elasticity maintained (cf. 5)
  • Non-palpable to patient and partner (cf. 3, 5) I wish you could speak to women who have this mesh in their bodies and you would know what this has done to them.

Stage of Prolapse: For mild, moderate, and severe prolapse

Preference and Approach: Customization based on physician preference Customize means the surgeon can cut it up and use it however he/she wishes.

Fixation Method: Digitex® suture delivery system, StatTack, or AbsorbaTack fixation technologies

IN 2008 the FDA first put out a report on adverse effect of mesh used in women. However when I had surgery in March 2010, you could not find out anything unless you knew key words so I had no clue about the 2008 FDA report. Now it is much easier to find things because I know how to search. This is from that report.

III.SUMMARY OF ADVERSE EVENT REPORTS

The FDA conducted a search of the Manufacturer and User Device Experience (MAUDE) database for medical device reports (MDRs) of adverse events associated with all urogynecologic surgical mesh products received from January 1, 2005 – December 31, 2010. The search identified 3,979 reports of injury, death, and malfunction. Among the 3,979 reports, 2,874 reports were received in the last 3 years (January 1, 2008 – December 31, 2010), and included 1,503 reports associated with POP repairs and 1,371 associated with SUI repairs. The number of MDRs associated with POP repairs increased by more than 5-fold compared to the number of reports received in the previous 3 years (January 1, 2005 – December 31, 2007).

Multiple factors can affect MDR reporting, including increased use of urogynecologic surgical mesh in the clinical community, increased awareness on the potential adverse events associated with mesh after the 2008 PHN, an increased number of new POP meshes on the market, or an increase in the number of actual adverse events associated with mesh. Determining the exact cause or causes of the increase is difficult. Regardless, the FDA believes the overall increase in the number of serious adverse event reports is cause for concern.

From 2008 to 2010, the most frequent complications reported to the FDA from the use of surgical mesh devices for POP repair included vaginal mesh erosion (also called exposure, extrusion or protrusion), pain (including painful sexual intercourse known as dyspareunia), infection, urinary problems, bleeding, and organ perforation. There were also reports of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage and emotional problems. Many of the MDRs cited the need for additional intervention, including medical or surgical treatment and hospitalization. Vaginal shrinkage was not reported in the previous three year period corresponding to the 2008 PHN.

Between 2008 and 2010, there were seven reported deaths associated with POP repairs. Follow up investigation on the death reports revealed that three of the deaths associated with POP repair were related to the mesh placement procedure (two bowel perforations, one hemorrhage). Four deaths were due to post-operative medical complications not directly related to the mesh placement procedure.


Has any of this changed the amount of procedures done here in the U.S? No! In fact the number of procedures using mesh are rising. I had to dig deep to find an answer but found this.

After propensity score matching, patients who received the surgery with mesh had a higher chance of having a reintervention within one year and 47 and were more likely to have urinary retention within 90 days)), compared with those who received surgery without mesh. In subgroup analyses based on age, mesh use was associated with an increased risk of reintervention within one year in patients under age 65 years, and increased risk of urinary retention in patients aged 65 years and over. Despite multiple warnings released by the US Food and Drug Administration since 2008, use of mesh in pelvic organ prolapse surgery continues to grow.

So what is Restorelle made of? I downloaded the newest pamphlet that is supposed to be given to women BEFORE they decide on surgery. I wonder how many women were ever actually given one and if so did her surgeon sit with her and answer all the questions written on this pamphlet. So I began to read through it and took the following excerpts to share with you.

Are there any risks with mesh?

Mesh reinforced prolapse repair may not be suitable for every patient, and a thorough discussion between you and your doctor will enable both of you to determine if this treatment is right for you. There are many considerations when deciding to place surgical mesh and these should be discussed before any surgery with your doctor. Your medical and surgical history will help determine if a procedure with mesh is right for you. Potential complications from mesh surgery may include: pain, slow healing of mesh infection or non-healing, mesh extrusion from the vagina, mesh erosion into adjacent organs, nerve injury, recurrent prolapse, inflammation, adhesion formation, fistula formation, narrowing of the vagina, scarring, pain with intercourse, and mesh contraction. As with any surgery, other potential complications can include bleeding, infection, injury to blood vessels, nerves, bladder, urethra or bowel injury during mesh placement and may require additional surgery to repair. Difficulty with urination or defecation can temporarily or permanently occur as well. Talk to your doctor about these risks and reactions. It is important that you understand and consider the potential risks of a permanent mesh implant as well as the benefits when choosing the best treatment option for you. Your doctor can share with you the clinical data, safety, and efficacy of Restorelle® Smartmesh® and the use of Restorelle Smartmesh in sacrocolpopexy procedures. It is also recommended to speak with your surgeon about their success and complication rates using Restorelle Smartmesh and sacrocolpopexy procedures.

And this

Can pelvic organ prolapse be treated? There are different treatment options available and your doctor will be able to help you find the best solution for you. Treatment will depend on the type and cause of your prolapse as well as your plans for the future, such as whether you are planning to become pregnant. It is common for treatment to start with a non-surgical approach such as Kegel exercises, a pessary (a device worn in the vagina for support), estrogen supplementation or biofeedback. However, some pelvic organ prolapse may only be corrected with surgery.
This booklet explains a surgical treatment that can provide relief from pelvic organ prolapse. However, surgery is not suitable for everyone and you should discuss all treatment options with your doctor. And the following.

Ask your surgeon these questions before you agree to have surgery in which surgical mesh will be used:2• Why do you think I am a good candidate for surgical mesh? •    Why is surgical mesh being chosen for my repair? •    Are you planning to use mesh in my surgery? •    What are the alternatives to surgical mesh repair, including non-surgical options? •    What are the pros and cons of using surgical mesh in my particular case? How likely is it that my repair could be successfully performed without using surgical mesh? •    Will my partner be able to feel the surgical mesh during sexual intercourse? What if the surgical mesh erodes through my vaginal wall? •    If surgical mesh is to be used, how often have you implanted this particular product? What results have your other patients had with this product? •    What can I expect to feel after surgery and for how long? •    Which specific side effects should I report to you after the surgery? •    What if the mesh surgery doesn’t correct my problem? •    If I develop a complication, will you treat it or will I be referred to a specialist experienced with surgical mesh complications? •    If I have a complication related to the surgical mesh, how likely is it that the surgical mesh could be removed and what could be the consequences?

So to help you understand even more, I kept searching and found information on the person who patented Restorelle.

Over 10 years ago, a urogynecologist set out to develop a mesh specifically with a woman’s anatomy in mind. He created Restorelle Smartmesh.®

In 2001, Dr. James Browning began a project to develop a low impact medical device for the treatment of pelvic organ prolapse. He believed that the standard material of the time, a stiff mesh commonly used in abdominal hernia surgery, simply was not ideal for a woman’s unique anatomy and healing requirements. What he created was Restorelle Smartmesh: A physiologically compatible, ultra-lightweight mesh that encourages superior collagen growth for optimal results. More importantly, he created a mesh that renews and restores a woman’s body, as well as her quality of life.

Today, Restorelle Smartmesh® continues to be the only mesh designed with a woman’s anatomy and tissue healing requirements in mind. So you can be confident knowing you are working with a mesh backed by safety and science. And she can be confident knowing that there is life after prolapse. Simply put, Restorelle Smartmesh is engineered to deliver better outcomes — for you, and for her.

It also states it has been in use since 2004 and I believe this pamphlet is the original pamphlet on this implant, possible for doctors only to read, and it was printed before the FDA warnings.

Restores patient anatomy and renews quality of life for optimal outcomes

93.5%    clinical    cure rate

    99% cure rate transvaginally

    Less than 1% erosion

    Low incidence of de novo dyspareunia

    Vaginal elasticity maintained

Non-palpable    patient and partner

    Significant bowel function improvement

And now for the clincher.

Patented polypropylene design is the lightest weight mesh available in Female Pelvic Health

    In a canine integration histology study, two types    of monofilament polypropylene mesh were compared with different pore sizes, mass densities, and burst strengths.    Tests performed on the 90th post-operative    day resulted in: – 71% more mature type 1 collagen growth reported in Smartmesh – Less fibrosis – Less chronic inflammation and foreign body complications – Post-implant strength of Smartmesh was as strong or stronger than the heavier-weight mesh

I knew about the study on dogs of course and here is really what happened to those dogs.

D. VNUK, D. MATICIC, M. KRESZINGER, B. RADISIC, J. KOS, M. LIPAR, T. BABIC Clinic of Surgery, Orthopaedics and Ophthalmology, Faculty of Veterinary Medicine, University of Zagreb, Zagreb, Croatia

ABSTRACT: In 16 male dogs who suffered from perineal hernia, polypropylene mesh was used to close a defect in the pelvic diaphragm. Pelvic bone was drilled on the pelvic floor and mesh was sutured through holes by polypropylene suture. Strong pelvic diaphragm, good long-term results and time-sparing by this technique was achieved. Suture sinuses were developed in two dogs one month postoperatively. Objectives of this study were to describe a new alternative technique of perineal herniorraphy and postoperative possible complications. Weakness of internal obturator muscle flap is complication which can be observed during transposition of internal obturator muscle flap. This technique can be used when internal obturator muscle flap is weak like the operation of the first choice.

I had to cut out most of it because it is very long and too long for this blog. But here is the ending. You can however, download all of it and read for yourself.

Disadvantage of this technique is high cost of polypropilene mesh. Rectal diseases were noticed in 11 dogs. (This is HUGE and many women have had all or part of their colons removed after surgery.) Because of potential for continued straining postoperatively and resultant herniorrhaphy failure, some surgeons recommend excision of rectal diverticula and large sacculations and suturing of the rectal wall at the time of the herniorrhaphy procedure (Krahwinkel, 1983). Larsen (1966) reduced in size rectal diverticula by placing a few interrupted Lembert sutures into the muscularis of the rectum at the time of herniorrhaphy. We used method of plication, placing some layers of Cushing suture depend on width of rectal diverticula. this method was prefered because of opening of the rectal wall is not necessary and risk of possible contamination during sacculectomy is huge. Resolving of rectal disease by plication can be complicated by rectal prolapse (Larsen, 1966). In this case method of plication was done in 10 dogs and rectal prolapse was not observed. This technique carried out a strong pelvic diaphragm, good long-term results and it is a time sparing. This technique can be used in case of weakness of internal obturator muscle flap like the operation of the first choice.

So to help you understand more, I downloaded the original motion for trial written by lawyers who were suing Coloplast on behalf of women. Here is some of it. I can’t download all because it is 55 pages long, but you can do this on your own. Just put in ‘motion for trial Coloplast’ and you should come up with the document.

39. On December 5, 2005, Mentor obtained 510(k) clearance for Mentor NovaSilk Mesh. Mentor NovaSilk Mesh is a permanent, synthetic knitted propylene mesh that is square in shape and is a sterile, single use device. The Mentor NovaSilk Mesh obtained 510(k) clearance based on substantial equivalence in material, function, performance, and design to the Gynemesh Prolene Soft (Polypropylene) Mesh cleared under 510(k) K013718 and knitted polypropylene already in use under Mentor’s Aris Sling cleared under 510(k) K050148. Joshua H. Levine, President and Chief Executive Officer of Mentor Corporation commented, “The addition of NovaSilk to Mentor’s expanding portfolio of women’s health products for pelvic organ prolapse or stress urinary incontinence reinforces the commitment of our urology franchise to surgeons and the patients they serve by providing high quality product offerings and customer service and support.”

Mesh, Exair-Prolapse Repair System, Restorelle, Smartmesh, Omnisure, and Minitape as well as any variations of these products and any unnamed Coloplast pelvic mesh product designed and sold for similar purposes, inclusive of the instruments and procedures for implementation. In addition, Coloplast manufactures, distributes, and sells products made of biologic materials known as Suspend-Tutoplast Processed Fascia Lata and Axis-Tutoplast Processed Dermis as well as any variations of these products and any unnamed Coloplast Pelvic Mesh Product designed and sold for similar purposes, inclusive of the instruments and procedures for implementation

Why are doctors now getting away from the word mesh and calling it silk? It’s all in a name. I found this about Novasilk on another link.
One of the more popular devices is the
Novasilk mesh, manufactured by Coloplast. The Novasilk mesh is a transvaginal mesh used to help correct pelvic organ prolapse by reinforcing the weakened tissue and stabilizing the vaginal wall. Introduced to the market in 2005, Novasilk was not required to undergo testing based on its similarity to an already approved device by the FDA. Novasilk is a synthetic mesh made of polypropylene, a lightweight material that is less stiff than previous mesh designs. Similar to other mesh products, this product also does not come without the dangerous risks of erosion and exposure.

Here is a video showing how Exair is put into women. It is graphic but women need to learn more about implants that could be placed into their bodies. http://www.orlive.com/coloplast/videos/posterior-pelvic-floor-repair-using-exair-performed-by-dr-joseph-costa

You can read up on all Coloplast meshes here

They have also studied mesh in sheep. You can read this to learn more http://www.meshangels.com/mesh-in-sheep/

If you are a victim of Coloplast mesh, please leave a comment anonymously so other women know they are not the only ones.

Now continue on to part two of the Coloplast Catastrophe. http://www.meshangels.com/coloplast-catastrophe-part-2/

5 Comments

  1. T

    Coloplast is what destroyed my life, & I NEVER asked for it. 3 times my doctor told me he didn’t use mesh. He was only making a new “hammock” to support my bladder neck or else I would pee uncontrollablely all the time after my hysterectomy. He said all women who had hysterectomies peed themselves if their bladder neck wasn’t given a new hammock during the hysterectomy. At 7 weeks post op I was still in so much pain, unable to urinate (never given the option to self cath or have a Foley), couldn’t walk, etc. I went yet again to Dr, and asked when would I ever get better due to all this & my husband and I both could feel something internally. At this appointment the Dr then called it “tape”. He never said mesh. I had already suspected he was lying and was reading this blog. I immediately went to hospital to get my surgery notes to find out what “tape” I had. Coloplast will never pay for all my suffering & lost life. I’m young, 30s, with children who have no mom and a husband with no wife.

    Reply
    1. Linda (Post author)

      T your story is so sad and like many women’s stories which is why I am writing about the mesh manufacturers and the people who do this to us. The doctors! They have names and faces and I will try to find photos of them whenever possible. I hate what they have all done to women and they get away with it without paying proper compensation.

      Reply
  2. suzette

    Also had tvt from coloplast in south africa

    Reply
    1. Linda (Post author)

      Suzette I am going to put you in touch with other women in your country.

      Reply
  3. Marie

    Morning
    we are looking for ladies in South Africa with Tvt sling complications
    Coloplast

    Reply

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