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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Friday, February 8, 2013

A Life Adversely Affected: You Kill Me, Boston Scientific!

This video is of a Texas woman who is disabled as a result of a Boston Scientific TVT sling implanted product.  

Keep this video in mind as you read the following:  medical device profit is private, patient harm as a result of failed innovation is often public - taxpayer obligation.  The patient is harmed and in medical and legal purgatory.  Public funds often are necessary to sustain families and the elderly from poverty and neglect.

 by SHIV GAGLANI on Feb 5, 20133:38 pm  FiDA highlight

The next speaker was John Abele, the founder of Boston Scientific and chairman of FIRST (“For Inspiration and Recognition in Science and Technology”), which promotes student involvement in robotics. Abele mirrored Diamandis’ talk and gave an overview of certain elements to consider when thinking about exponential growth and the “law of accelerating returns.” He began by opening up with the prediction that “advances in technology in the next five years will exceed those in the past five years.” There are a number of reasons for this including the improved access to and democratization of information, ability to communicate with experts, more and better materials for modeling and analysis, cheaper and more powerful tools for testing, increased ability to learn new skills, and the long-tail phenomenon that speaks to the rise of niche markets. One of the specific issues within medicine however is that while med tech is also growing exponentially, the rate of medical technology assessment is still growing linearly, leading to a bottleneck of the implementation of potentially life-saving technologies. Abele spoke of an “omission versus commission” problem: regulators often do not approve innovations that may save 10 lives for fear that they will adversely affect one life. Aren’t we effectively killing 10 people by not approving some of these technologies? That question leads to deep philosophical arguments (Kant v Mill, anyone?) that were beyond the scope of the 1-hour talk. Abele wrapped up by discussing the importance of collaboration to applying the law of accelerating returns to medical innovation.

(Mr. Abele,  FiDA fears that it is all about "returns" and profit and not at all about improving the lives of patients.)

A late-breaking story:  (partial copy only)

ATLANTA (AP) — Soon after her surgery, Susan Harrison had a string of infections that caused intense pain, leaving her weak and unable to pick up and play actively with her young grandchildren. The discomfort and fatigue often kept her from her job as a kindergarten classroom assistant.
For years, Harrison thought it was just an unfortunate consequence of the surgery to repair weak muscles in her pelvic region. But she discovered five years after her 2006 procedure that she was one of thousands of women who say their pain was caused by surgical mesh implanted to fix the problem.
"I felt so bad, I felt sad thinking that I had to spend the rest of my life living this way," Harrison said.
The mesh is most commonly used after pelvic organ prolapse, or when muscles in the area weaken, causing organs to bulge or slip down into the vagina. It can happen because of age, childbirth or other reasons and can cause pain and bladder leakage.
While many women benefit greatly from the mesh surgery, the Food and Drug Administration has warned some can suffer complications, and many women have sued, claiming manufacturers should have warned of potential harm. But some doctors have said the FDA's warning — and the lawsuits against the manufacturers — are misguided. The doctors blame inexperienced surgeons.
Harrison's case is among more than 6,000 federal lawsuits against some of the biggest manufacturers of pelvic mesh products. The cases have been consolidated in a federal court in West Virginia, with some trials to begin this year.
The lawsuits accuse the companies of inadequate testing, failing to disclose potential risks and fraudulently promoting the mesh as a safe medical device. The manufacturers deny those allegations in court documents. Some companies have said in statements their testing was rigorous, that their products are safe and effective and that they're working with the FDA. Some companies declined to comment, citing ongoing litigation.
The lawsuits seek unspecified compensation for pain and suffering, reimbursement of medical costs and punitive damages.
Harrison had most of the mesh removed in October 2011. She said she still feels weak and has bladder leakage that requires her to take extra precautions when she leaves the house, but she feels better than she has in years.
Lynn Waits, a former police officer-turned-nurse from Covington, Ga., had incontinence and pelvic collapse after having two children. She said she experienced bleeding and severe pain immediately following her mesh surgery in 2008.
The incision next to her vagina never fully healed and she could feel the mesh if she touched that spot, she said. She continued to have bleeding for two years until she finally went to another doctor and had the mesh removed in 2010, she said.
She still has shooting pains, a constant achiness and can't take a long car ride without discomfort, which she blames on the mesh. The experience has also changed her marriage.
"Since I had surgery, sex is out. I'm celibate," she said. "Now it's a very platonic relationship. You get used to it."
Kathy Barton's doctor suggested the mesh when she mentioned that she had bladder leakage when she laughed or coughed. Shortly after the surgery, it felt like razors were slicing her organs and a sharp edge of the mesh cut her boyfriend during sex, she said. Even though she eventually had it removed, the 55-year-old west Georgia woman still has pain she believes is caused by the mesh.
When pelvic mesh products were introduced, they were seen as a high-tech improvement over traditional surgery using stitches and a woman's own body tissue, which also can have complications. Since similar mesh was already used in other types of surgery, including for repairing hernias as far back as the 1950s, the products received fast-track approval from the FDA without the tests that the agency requires for first-of-a-kind devices.
The FDA cleared the mesh — often a soft, lightweight porous plastic — for pelvic organ prolapse in 2002, and the agency said in a 2008 public notice that problems were "rare." In July 2011, however, the agency said it erred in its initial assessment and estimated the most common problems occur in 10 percent of women within a year of surgery.
One of the lead attorneys representing women suing the mesh manufacturers, Athens, Ga.-based lawyer Henry Garrard, said problems may arise because some surgeons don't know much about mesh, but he said it's the manufacturers' responsibility to educate doctors about their products. For the most part, his clients have not sued individual doctors, he said, because he claims the problems are caused by the mesh products themselves.
A trial for five bellwether federal cases against Bard is set for June and trials for American Medical Systems, Boston Scientific and Johnson & Johnson subsidiary Ethicon are staggered over the next year.

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