Copyrighted by Lana C. Keeton November 9, 2012
*all rights reserved
Boston Scientific brought its’ first bladder suspension sling, the Protegen Sling, to market based on a 90-day rat study, and the wide use of its Hemashield fabric for cardiovascular grafts. Nov. 15, 1996, the FDA granted clearance for the Protegen Sling but 56 serious adverse events were reported in the first 9 months on the market. 57 were reported in the next 6 months.
During a June 1998 inspection of the company’s manufacturing plant, the FDA found the company was not reporting a large percentage of adverse events. Internal company documents showed at least 233 other reports never given to the FDA. Boston Scientific had selectively reported cases of surgical removal of the mesh and omitted other equally dangerous medical complications.
So what has changed at Boston Scientific since 1998? Based on the current investigation of BSX by California Attorney General Kamala Harris and other states attorneys, not much. Boston Scientific continues to market deadly synthetic surgical mesh for pelvic organ prolapse and bladder suspension through its Urology/Women’s Health division.
Promotion of dangerous medical devices to unsuspecting patients is the norm because of lax regulatory authority, the snails pace of FDA actions and the device industry’s strangle hold over doctors, professional medical societies and billions of dollars spent on direct to consumer advertising and lobbying in Congress.
But we as patients and patient advocates have made a difference and here’s why!
We have influenced the national conversation on the regulatory process with our testimony about the failures of the 510 (k) at the Institute of Medicine in 2010 and we decreased their sales because of the FDA’s July 2011 Transvaginal Mesh Warning! Read and enjoy….
From Boston Scientifics’ 3rd Quarter 2012 Form 10Q SEC filing:
Under “Women’s Health/Urology” they say:
However, our Women's Health business declined 11 percent primarily due to continued pressures on elective procedures and lower sales levels following the FDA release of a Public Health Notice update in July 2011 regarding complications related to the use of urogynecologic surgical mesh for pelvic organ prolapse.
Under “Litigation and regulatory compliance” they state:
Our ability to minimize or avoid future field actions or FDA warning letters relating to our products and the on-going inherent risk of potential physician advisories or field actions related to medical devices;
Legislative or regulatory efforts to modify the product approval or reimbursement process, including a trend toward demonstrating clinical outcomes, comparative effectiveness and cost efficiency, as well as other healthcare reform legislation.
And we are hitting their bottom line!!
“Our accrual for legal matters that are probable and estimable was $411 million as of September 30, 2012 and $299 million as of December 31, 2011…”.
And for the early 2000’s even before the current investigations, “the total incremental tax liability now asserted by the IRS for the applicable periods is $1.162 billion plus interest.”
MOST MESH INJURED PATIENTS HAVE BEEN HORRIBLY INJURED BUT AT LEAST THERE IS HOPE OTHERS WILL NOT BE HARMED IN THE FUTURE!