Houston medical device injury attorneys mention that Johnson & Johnson (J&J) put its Gynecare Prolift vaginal mesh product on the market in 2005 as an “innovative and effective surgical option” intended for prolapse repair. J&J decided (apparently unilaterally) the Gynecare Prolift product qualified as an exception to the regular FDA approval process on the basis that it was similar to a medical device called the Gynemesh Prolene Soft Mesh that had already been approved by the FDA. But the differences, in our opinion, greatly outweighed the similarities.
Our Houston medical device injury attorneys note that even when a product qualifies for the FDA’s expedited approval process because it is based on a “predicate” to which it is substantially equivalent, the maker of the product still should file a 510(k) application requesting the expedited approval. Morgan Liscinski, an FDA spokeswoman, said that the FDA had never heard of the Gynecare Prolift product until 2007 when J&J cited it as a predicate in the application for another product. While both products received FDA approval in 2008, the spokeswoman’s statement would indicate that J&J had not even filed a 510(k) application for the Gynecare Prolift before marketing it to unsuspecting women in need of pelvic prolapse repair.
Reportedly, the J&J application citing Gynecare Prolift as a predicate for Prolift+M said that the Prolift product represented an “insignificant” change from the approved Gynemesh Prolene Soft Mesh product that it used as its predicate.
But the Prolene Soft Mesh product was intended to repair hernias and other connective tissues, while the Prolift was intended to repair full pelvic organ prolapses. Our Houston medical device injury attorneys point out that the difference in magnitude between the problems addressed by the products is significant. The complexity of the two problems is significant. And the difference in magnitude between the complications that the two types of repairs could cause is significant. And while the Prolift and Prolene products were composed of the same non-absorbable polymer material, the Prolift product also included special pre-cut mesh sections and instruments for surgeons to use in implanting the product.
The FDA received 123 complaints about the Prolift product between 2005 (when J&J placed it on the market without approval) and May 15, 2008 (when the FDA cleared the medical device for market). Our Houston medical device injury attorneys emphasize that the FDA approval came in spite of the high number of complaints. Since then, hundreds more complaints, some involving fatal injury, have been tendered to the agency regarding surgical mesh in prolapse repairs.
J&J is facing hundreds of lawsuits involving the mesh product. The amount J&J may be required to pay to settle all these suits could well devour any profits the company made by stealthily marketing the product without FDA approval. So the strategy of putting profits before patient health concerns might reveal some severe flaws. Let’s hope other medical device makers heed the warning.
The FDA had noted a high incidence of complaints involving surgical mesh implants to repair pelvic organ prolapse some years ago. But 2008 guidance from the FDA indicated that the products were safe for use. Yet in 2011, the FDA re-examined its stance on transvaginal surgical mesh implants after finding a fivefold increase in injuries, complications, malfunctions, and fatalities tied to the products. In September 2011, an FDA advisory panel urged the agency to reclassify transvaginal surgical mesh implants as high-risk medical devices that required human testing in clinical trials prior to approval.
The FDA’s vacillation on the risks of medical device products, the ability of companies like Johnson & Johnson to slip high-risk products past the FDA and onto the market without approval, and the FDA’s conduct in approving products with a high number of complaints has raised questions about the efficacy of the FDA approval process. Some lawmakers, medical professionals, and consumer groups are calling for review of and change to the process to protect patients.
And a string of high-profile medical device product recalls has eroded public confidence both in the FDA oversight process and in the medical device market. Our Houston medical device injury attorneys remind readers that J&J has also been plagued by recalls of over-the-counter medications and artificial hip implant products. Three J&J units have recently pleaded guilty in cases involving bribery and/or the illegal marketing of drugs. And a fourth J&J unit agreed to plead guilty on a marketing charge.
The Houston medical device injury attorneys at Denena & Points have been following on this website the controversy over the FDA approval process and surgical mesh to repair pelvic prolapses. If a medical device product has injured you, contact us for a free and confidential legal consultation to learn your available options for a full financial recovery on the harm you’ve suffered. You can call us toll free at 877-307-9500 or use our online contact features to schedule your free consultation/case evaluation.