Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
Please share what you have learned!
Twitter: JjrkCh

Wednesday, May 25, 2016

J&J Sold Pelvic Mesh While Concealing Risks: Washington State Attorney General

  • FOR IMMEDIATE RELEASE: 
May 24 2016  FiDA highlight
Complications left women permanently disabled, in chronic pain
SEATTLE — Attorney General Bob Ferguson filed a consumer protection lawsuit today against Johnson & Johnson, accusing the company of knowingly concealing the risks associated with a surgical mesh designed to treat pelvic floor conditions in women. As a result of Johnson & Johnson’s deception, thousands of Washington women face urinary and defecatory dysfunction, loss of sexual function, chronic inflammation, chronic pain, and risk of chronic infection.
These complications can crop up years after the surgery, and are in many cases irreversible. Removal of the mesh is nearly impossible.
“It’s difficult to put into words the horrific injuries and pain many women are still suffering as a result of Johnson & Johnson’s deception,” Ferguson said. “They believed they were making informed medical decisions, but that was impossible when Johnson & Johnson was spreading inaccurate information about its products’ risks, essentially duping doctors into using their own patients as clinical trials. This is an unacceptable way of doing business, and I will hold the company accountable.”
The lawsuit alleges thousands of violations of the Washington Consumer Protection Act, due to deceptive informational and marketing materials distributed to consumers and doctors. The attorney general will ask the court to prohibit Johnson & Johnson’s misleading marketing, find the company violated the CPA, and impose the maximum $2,000 civil penalty per violation, in addition to costs, fees and restitution.
The state alleges tens of thousands of violations of the CPA, potentially placing penalties well into the millions of dollars.
Johnson & Johnson is the largest manufacturer and seller of these mesh devices in the U.S. Between 2005 and 2015, the company sold nearly 12,000 mesh devices in Washington.
The mesh is made of woven polypropylene threads, and is marketed to doctors and patients as a way to treat pelvic organ prolapse, or when organs shift from their normal position, and various bladder issues.
The mesh is inserted surgically, and is put into place by pulling it up through the vaginal canal, then through an incision in the vaginal wall, and finally permanently anchoring it in the body to hold up falling organs.
The mesh, its construction and infection-ridden insertion through the vagina have caused chronic infection, chronic inflammation, permanent loss of sexual function, and permanent urinary or defecatory dysfunction. The mesh can shift position and cut through the vaginal wall or into other organs.
One patient shared this about her ordeal:
“I experienced excruciating pain from day one. I felt as though my urethra was being strangled, I couldn’t pee, walking was out of the question, sitting was agony, & I couldn’t lie on my left side due to severe pain and numbness at my left groin area.  Over the course of the next 14 weeks I visited/was admitted to the [hospital] 10 times. … I had no quality of life.  My consultant likened the mesh removal as to ‘trying to remove chewing gum from hair.’  … I still suffer left side groin pain and numbness, buttock pain, sharp pains in my lower stomach and I am less continent now than I was pre-op.” 
A doctor described in a 2009 email to Johnson & Johnson: “I am currently getting a patient to the OR who had an anterior and posterior prolift implanted by another physician.  She will likely lose any coital function as her vaginal length is now 3cm, and there is mesh extruding literally everywhere. … This patient will have a permanently destroyed vagina.”  
The company never told consumers that the mesh can cause, and consumers are likely to experience, chronic foreign body reaction and chronic inflammation as the body constantly fights to rid itself of this foreign material.
The company never told consumers that mesh causes and harbors infection, which can indefinitely live in the small weaves of mesh.
The company never told consumers that severe erosion — or a complication where the mesh moves and protrudes into an organ or through the vaginal wall — causing chronic pain and dyspareunia, or painful intercourse, is a common complication.
One patient said, “[I] had all kinds of problems with chronic pain, bleeding, dyspareunia (even my husband complained of scraping and poking)…The pelvic pain was keeping me awake at night, and the only relief was to sit on a tennis ball. The thought living like that, sitting on a ball, wearing a diaper, splinting my perineum to have a bowel movement, having infrequent and miserable sex, and marital problems was almost more than I could bear.”
And the company never told consumers that this risk of erosion is lifelong, because the implant is permanent, or that erosion can cause chronic pain and injury to sexual partners.
Women who have Johnson & Johnson mesh devices and are experiencing symptoms can contact investigator MaryBeth Haggerty Shaw at MarybethH@atg.wa.gov or contact our Consumer Resource Center at 1-800-551-4636. Complaints can be filed at atg.wa.gov/file-complaint.
This case is being handled by Senior Counsel Lisa Erwin, Assistant Attorneys General Andrea Alegrett and Leilani Fisher. The case has been filed in King County Superior Court.
-30-
The Office of the Attorney General is the chief legal office for the state of Washington with attorneys and staff in 27 divisions across the state providing legal services to roughly 200 state agencies, boards and commissions. Attorney General Bob Ferguson is working hard to protect consumers and seniors against fraud, keep our communities safe, protect our environment and stand up for our veterans. Visit www.atg.wa.gov to learn more.
- See more at: http://www.atg.wa.gov/news/news-releases/ag-files-major-lawsuit-against-johnson-johnson-over-concealed-risks-pelvic-mesh#sthash.V0tz1X8g.Myhh7sWx.dpuf


http://www.atg.wa.gov/news/news-releases/ag-files-major-lawsuit-against-johnson-johnson-over-concealed-risks-pelvic-mesh

Peter Lavallee, Communications Director, (360) 586-0725; PeterL@atg.wa.gov

No comments:

Post a Comment