New York, New York (PRWEB) April 20, 2015
Americas Health Insurance Plans (AHIP), the trade association representing the U.S. health insurance industry, is seeking greater regulation of medical devices as a result of the recent controversy involving surgical tools called power morcellators (http://www.morcellatorlawsuit2015.com). In a letter to U.S. Senator Robert Casey (D-PA) dated April 14th, the group asserted that the safety concerns surrounding uterine morcellation point to serious gaps in the current approval and post monitoring process for medical devices.” Among other things, the letter called for a strengthening of the pre- and post-market review processes, particularly the U.S. Food & Drug Administrations (FDA) 510(k) clearance program for medical devices, which allowed power morcellators to come to market without the benefit of human testing.*
The AHIP is correct that the power morcellator issue illustrates the need for stronger medical device oversight, and we commend the organization for bringing attention to this important public health issue. In particular, we agree the 510(K) system should be reviewed, as morcellators are far from the only devices cleared through this program that would later become the subject of safety concerns.** In fact, we are currently litigating numerous medical device lawsuits involving transvaginal mesh, metal hip implants and other products that have gone through this process,” says Sandy A. Liebhard, a partner at Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. The Firm is providing free legal consultations to women who were diagnosed with advanced uterine cancer following surgery with a power morcellator.
FDA 510(k) Clearance
Under the FDAs 510(k) program, a medical device is not required to undergo human testing if a manufacturer can prove that the product is substantially equivalent to a device that is already on the market. In 2011, the Institute of Medicine called on the FDA to eliminate the 510(k) program entirely, after concluding that a reliance on substantial equivalence cannot assure the safety and effectiveness of medical devices reviewed through this process.***
Power morcellators are used in minimally-invasive hysterectomies and fibroid removal procedures to shred tissue so that it may be removed through a small abdominal incision. On April 17, 2014, the FDA issued a public alert which discouraged doctors from using the devices in gynecological procedures, due to their potential to spread and upstage undetected uterine cancers.**** This past November, the agency updated its earlier alert, and warned that the devices should not be used on a majority of women who require these types of surgeries because of this risk. Among other things, the FDA pointed out the difficulty in screening for uterine malignancies prior to surgery, and noted that the dissemination of these cancer cells greatly reduces a womans odds of long-term survival.
Alleged victims of uterine cancers that were spread via a power morcellator may be entitled to compensation for their injury-related damages. To learn more, please visit Bernstein Liebhard LLPs website, or call the Firm directly for a free, no-obligation case review at 800-511-5092.
*assets.fiercemarkets.net/public/AHIP_Letter_SenCasey_PowerMorcellators_41415.pdf, AHIP, April 14, 2015
**propublica.org/special/four-medical-implants-that-escaped-fda-scrutiny, ProPublica, April 30, 2012
***http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=13150, Institute of Medicine, September 2011
****fda.gov/medicaldevices/safety/alertsandnotices/ucm393576.htm, FDA, April 17, 2014
About Bernstein Liebhard LLP
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993. As a national law firm, Bernstein Liebhard LLP possesses all of the legal and financial resources required to successfully challenge billion dollar pharmaceutical and medical device companies. As a result, our attorneys and legal staff have been able to recover more than $ 3 billion on behalf of our clients. The National Law Journal has recognized Bernstein Liebhard for twelve consecutive years as one of the top plaintiffs’ firms in the country. Bernstein Liebhard LLP is the only firm in the country to be named to this prestigious list every year since it was first published in 2003.
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