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.
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Tuesday, July 15, 2014

Lady Parts, Greg Abbott and JNJ Deceptive Trade Practices Mesh Up

By Amy Silverstein
Published Fri., Jul. 11 2014 at 7:08 AM

Future Texas Governor Greg Abbott hates nothing more than he hates abortions, Planned Parenthood and other women's-health-related things, leading the Texas Democratic Party to describe him as "public enemy number one for women in Texas." But now, in a major national fight pitting women's health advocates against a corporate giant, Abbott appears to have jumped in bed with women and their bodies.

For the past two years, the Texas Attorney General's office has been quietly leading an investigation into Johnson & Johnson's Ethicon subsidiary, after thousands of women nationwide alleged in lawsuits and complaints to the FDA that the company's pelvic mesh products are defective.
As I reported in a recent feature story on mesh, Ethicon and other companies thought they'd discovered a new, easy way to cure poor bladder control and similar health ills common in aging women and women who have had babies. The fix, rushed to the market in the late 90s, is a surgical device made out of plastic surgical mesh, inserted through the vagina. Patients have complained en masse that the "fix" destroyed their sex lives, worsened their incontinence and caused horrendous pain. More than 17,000 lawsuits have been filed against Ethicon alone.
The FDA was slow to respond, but in 2011 regulators finally issued a warning that complications from some of the mesh surgeries are "not rare." The FDA has yet to issue a formal recall.
Abbott, meanwhile, is investigating Johnson & Johnson under the Texas Deceptive Trade Practices-Consumer Protection Act. In a demand letter sent in April, the Attorney General asked Johnson & Johnson for physical samples of the mesh, detailed data on the material it's composed of, a list of all websites sponsored by Johnson & Johnson discussing the mesh and other data. That's only the latest request for information, following up on a separate demand the Attorney General sent in March 2013. The whole investigation began two years ago, the AG's office tells Unfair Park.
The investigation became public after a group of Texas women wrote a letter to Abbott asking him to crack down on the company, only to find out that he's already looking into it, as WFAA reported.

Women's health aside, Texas and other states have its own reasons to investigate this. "You, as a tax-payer, you're paying for the Medicare patients who have had this thing in," Dr. Daniel Elliott, a surgeon at the Mayo Clinic who treats women suffering mesh complications, told us a few months ago. "Then the patient has all these complications, and you as the taxpayer are paying for their original surgery and you're paying for all these treatments afterwards. It's a huge financial burden on the system."

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