Coloplast 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 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:
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.
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.