Johnson and Johnson asked Judge Goodwin in the MDL filed in West Virginia for the post-market studies of its four mesh product which have been withdrawn from the market, to be postponed.

Ethicon (J&J) Stops Sales of Transvaginal Mesh Devices

Ethicon announced in June of 2012, that it would stop selling these four transvaginal mesh devices:

Prolift,
Prolift +M
Prosima
TVT Secur

The cessation in sales came after the U.S. Food and Drug Administration (FDA) said it would order further study the Gynecare devices to verify their safety. In January 2012 the FDA ordered 31 transvaginal mesh device manufacturers to produce three years of data on the safety and effectiveness of their devices and procedures.

Ethicon stated:

This is not a product recall, and we continue to have confidence in the safety and efficacy of these products. Our decision to discontinue these products is based on their commercial viability in light of changing market dynamics, and is not related to safety or efficacy.

Johnson & Johnson already had issues with the marketing of Prolift.

History of Issues with Prolift

J&J launched Prolift in 2005 without FDA approval.  J&J claimed that attaining formal approval was unnecessary because the Prolift was so similar to the Gynemesh, which was already approved.

The FDA disagreed and asked the company to stop marketing Prolift until proper approval was obtained.

Recent evidence shows that Johnson & Johnson continued to sell the device for nine months after the FDA asked them to halt sales.

See Our Additional J&J Articles:

J&J History of Patient’s Rights and Litigation

Who is Ethicon: J&J

J&J Sold Mesh after Cease Sales FDA Ordered

J&J 3100 Pelvic Mesh Cases Filed

Pelvic Organ Prolapse Study

Sexual function in women following transvaginal mesh procedures for the treatment of pelvic organ prolapse. International Urogynecology Journal, 2012; 23 (10):1455-1460.

A current study recently published regarding Pelvic Organ Prolapse has been published in the International Urogynecology Journal .

The results indicate, “The study was conducted to demonstrate sexual function in women before and after surgery with transvaginal mesh (TVM) repair for pelvic organ prolapse (POP).”

Study of 93 Women

A total of 93 sexually active women scheduled for correcting POP with synthetic mesh kits were recruited.

In addition to urogynecological history, pelvic examination by the Pelvic Organ Prolapse Quantification system, and urodynamic testing, consenting participants were asked to complete the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) to evaluate sexual function before and after surgery.

Three month urodynamic studies, among the 25 patients with coexistent urodynamic stress incontinence (USI) who had undergone a concomitant transobturator suburethral tape procedure (TOT)

1 (4 %) had persistent USI

8 of 68 (11.8 %) patients with a negative pessary test developed postoperative USI

Six-month prolapse recurrence rates following TVM alone (9%) and TVM with concomitant TOT (12%) were 9 and 12 %, respectively.

The total PISQ-12 score after surgery showed worse results in the TVM alone group but not in the TVM with concomitant TOT group.

The individual scores of PISQ-12 after surgery demonstrated prolapse-related items improved in both TVM groups; sexual function worsened in dyspareunia and behavior domains.

“Our data revealed that transvaginal synthetic mesh procedures for the treatment of POP generated favorable clinical outcomes, but situations might worsen in dyspareunia and behavior domains, thereby invoking a negative emotional reaction during intercourse after surgery.”

International Urogynecology Journal

International Urogynecology Journal can be contacted at: Springer London Ltd, 236 Grays Inn Rd, 6TH Floor, London WC1X 8HL, England. (Springer – www.springer.com; International Urogynecology Journal – www.springerlink.com/content/0937-3462/)

Transvaginal tape (TVT) is still being used in Britain notwithstanding significant issues. Transvaginal Tape is a mesh implanted under the bladder like a hammock to support damaged pelvic organs after childbirth.

Fragments of TVT Cut into Surrounding Tissue

TVT tape is known to break up in the body, causing small fragments to cut their way into surrounding tissue particularly in the urinary tract.

This is called the ‘cheesewire effect’, because of the excruciating pain it causes resulting form internal lacerations from the product. The unrelenting pain is associated with infection, incontinence and a halt to their sex lives.

In Britain 2,659 Attempt so Remove TVT

Previous 107 complications with TVT were logged in the years between 2006 and 2011. But figures from the Department of Health have revealed that NHS hospitals in England recorded 2,659 attempts to remove defective transvaginal or transobturator tape.

Effect Felt by 500 More Women per Year in Britain

The latest NHS figures also show the number of affected women is rising by more than 500 a year, indicating that about one in 20 of the 13,500 operations a year to insert the material goes disastrously wrong.


Australia Dropped the Ball on Transvaginal Mesh Issue

In Australia the nation’s medical device regulator is known as the Therapeutic Goods Administration (TGA). The TGA relies on the manufacturer to advise the public of adverse medical devices are placed in use.

The Department of Health has revealed it manages the recall of about 500 medical devices every year and there has been a 100 per cent increase in recalls in the last five years.

In August of 2012, Johnson & Johnson withdrew its transvaginal mesh products from sale in Australia. The TGA never notified the public.

In Britain Transvaginal Mesh is a Serious Issue

The latest British National Health Service figures indicate the number of affected women is rising by more than 500 a year, indicating that about one in 20 of the 13,500 operations a year to insert the material goes disastrously wrong. TVM continues to be in use use in Britain and patients are not warned of the risks.

Previous official figures had recorded 107 complications with TVT between 2006 and 2011. The Department of Health has recently revealed that NHS hospitals in England recorded 2,659 attempts to remove defective transvaginal or transobturator tape.

A spokesman for Ethicon in the UK, owned by the pharmaceutical giant Johnson & Johnson, and one of the leading suppliers of the tape, says the company ‘continues to have confidence in the safety and efficacy of its products for the treatment of pelvic disorders, and has no plans to make changes to the materials used in products on the market’.

Who Is Coloplast CorpColoplast Corp. is a publicly traded company located in Denmark.  Each Quarter Coloplast files its report for that quarter and the CEO participates in a “Conference Call.”  Participation in this call appears to be scripted by their Investor Relations Department and questions will be received by “Invitation Only.”  The next call is scheduled for November 6, 2012.

Coloplast Responsiblity Report

Coloplast includes in its website a “Responsiblity” Report.  Based on the previous conference call which addressed the Q2 Report of Coloplast, we learned the “Responsibility” level Coloplast feels for its Pelvic Mesh system is minimal.  Perhaps that responsibility will be enhanced based on this Quarter’s Report and we will learn more about that on November 6, 2012 and in Q3 Quarterly filings which will most likely be released 24 to 48 hours prior to the Conference Call.

The Company appears to be earnest in its adherence to accountability and responsibility and publicly displays its corporate guidelines.  It is hoped the Company will follow the example of Johnson & Johnson and remove the sale of its product throughout its extensive international sales region.

Coloplast Claims:

Coloplast began as a small company in Denmark nearly sixty years ago. Today, we employ over 7,500 people and are represented in 55 countries around the world.

By acting responsible and setting a new standard of care in the many markets we’re present in, we drive growth for the business while at the same time live by our mission: to make life easier for people with intimate healthcase needs.

Previous Posts on Coloplast

See previous post on Coloplast and it’s last Quarterly Report for Q2 2012, including statement on Pelvic Mesh Systems.

Coloplast Corp. cases are filed as a Multi-District Litigation (MDL) in the Middle District of Georgia.  The Judge assigned these cases has promised discovery in these cases will not fall behind those cases filed in West Virginia as MDL’s against the defendants who also manufacture pelvic mesh systems.

MDL in West Virginia Defendants

In West Virginia the Multi-District Litigation Includes the Following Defendants:

  • American Medical Systems
  • Boston Scientific Corp.
  • Johnson & Johnson’s Ethicon
  • C.R. Bard

FDA Has Clear Concerns – Coloplast Appears to Have Ignored

Coloplast’s indifference to the consequences of their product’s potentially inherent danger are maintained despite the fact that in January of 2012, the FDA ordered manufacturers of vaginal mesh to conduct further research into the safety of their products. The Prolift implant was put on the market without FDA approval or adequate testing. Yet the surgery was marketed to women as a simple and routine outpatient procedure.

In October 2008, the U.S. Food & Drug Administration (FDA) issued a public health notification warning that transvaginal placement of mesh device systems could lead to potentially serious complications including erosion of the material, infection, pain, urinary complications, and recurrence of prolapse or incontinence.

Ethicon Stops Sales of Transvaginal Mesh Devices

Ethicon announced in June of 2012, that it would stop selling these four transvaginal mesh devices:

Prolift,
Prolift +M
Prosima
TVT Secur

The cessation in sales came after the U.S. Food and Drug Administration (FDA) said it would order further study the Gynecare devices to verify their safety. In January 2012 the FDA ordered 31 transvaginal mesh device manufacturers to produce three years of data on the safety and effectiveness of their devices and procedures.

Ethicon stated:

This is not a product recall, and we continue to have confidence in the safety and efficacy of these products. Our decision to discontinue these products is based on their commercial viability in light of changing market dynamics, and is not related to safety or efficacy.

Coloplast Conference call of August 2012, indicated the company continues sales of the Mesh for Pelvic Floor Repair.

Lars Rasmussen is the CEO of Coloplast, and the CFO is Lene Skole.

Coloplast in Growth Mode

Q2 delivered 5% organic growth for the quarter and 6% year-to-date. Adjusted the growth for the quarter was 4%.

The Company reported a solid EBIT margin of 29% for the nine months of 2011/2012 and 32% for Q3 in isolation.

The Company expects around 6% organic growth for the full year and expects 8% reported growth based on current exchange rates.

Revenues were up by 6% organically and 8% in Danish krone.

Revenues for Q2, 2012 amounted to almost DKK 8.2 billion or roughly $15 million USD.

Sales Continue for Mesh for Pelvic Floor Repair

In Urology Care, organic growth was 5% for the first nine months of 2011/2012 and 4% for Q3 in isolation. Sales of female slings continued to decline while sales of mesh for pelvic floor repair remained satisfactory in Q3. Sales growth of penile implants continued its satisfying performance during the quarter. European Urology business saw a slightly weaker quarter with no particular or identifiable reason behind it.

CEO Discusses Product Liability Mesh Cases and the FDA

LARS RASMUSSEN: On the FDA safety update on mesh the CEO takes an indifferent stance and position with regard to the women being harmed by the Company’s product.

He noted in the conference call that in July 2011, the US Food and Drug Administration issued a safety update regarding the use of transvaginal mesh for pelvic organ prolapse and since then several mesh companies including Coloplast have become involved in a number of product liability actions on the use of this mesh for pelvic organ prolapse especially in incontinence.

Coloplast has Products Liability Insurance

Lars Rasmussen States:  At this point in time, the number of actions potentially involving Coloplast represents a minor share of the total number of actions and currently we have a little more than 100 claims against Coloplast. With our current knowledge, we don’t expect this to have a negative financial impact on Coloplast and we do also have a product liability insurance in the US.

This is basically as much as we do know and that we can say at this point in time on the mesh situation.

Could it be with Johnson & Johnson withdrawing FOUR pelvic mesh products from the market in June of 2012 — Coloplast sees a business opportunity at the expense of American women?  It would be naive not to believe so.

Judge Carol Higbee of the New Jersey Superior Court is presiding over more than 1,000 transvaginal mesh cases.

Video Tape Depositions Ordered J&J Execs

Three top Johnson & Johnson executives have been ordered to testify in deposition via video tape regarding their knowledge of the safety concerns surrounding the vaginal mesh lawsuits.

Order allowing deposition and search of computers for “search terms” by Judge Higbee – Link Here.

At this time the multicounty litigation section is NOT an electronic filing or imaging system. However, there is a Pelvic Mesh webpage at the clerk’s website: http://www.judiciary.state.nj.us/mass-tort/pelvicmesh/index.htm

Orders and Decisions Pelvic Mesh Cases in New Jersey

Orders and Decisions regarding C.R. Bard

Orders and Decisions regarding Johnson & Johnson, Ethicon, Inc., and Gynecare

Important pleadings such as master complaints, court decisions and orders are posted at the court’s discretion.