One may wonder if the maneuverings employed by Johnson & Johnson for its Gynecare Prolift vaginal mesh were worth it if we take into consideration that as of February 2013 there were already over 6,000 pending cases which may translate to $660 billion in potential damages. First, they went on with their product launching even if premarket tests showed that their vaginal mesh prototype held a 20 percent failure rate. Second, the Prolift was distributed without getting clearance from the Food and Drug Administration.
The company was able to beat its competitors to the draw when the Prolift vaginal mesh was made available in the market in 2005. The FDA learned that this particular product did not undergo approval process only in 2007 or two years after.
This was discovered only when J & J sought a clearance for a new product under the 510(k) prenotification process using the Gynecare Prolift as the predicate device. Asking the FDA to approve a new product using as predicate a device which never passed their system must have come as a surprise to them.
A notice was immediately issued by the FDA ordering J & J to stop the marketing of the Prolift and submit an explanation. Results of clinical tests conducted on this product were also required by the agency. When this order came, Prolift was in the market for almost three years with these devices being implanted on thousands of women including Linda Gross.
In their explanation, J&J claimed that they were not obliged to seek clearance since this product was substantially similar to the Gynecare Gynemesh which was already available in the market. Despite the order from the FDA to immediately cease distribution of the products, J & J continued selling the Prolift vaginal mesh devices.
It has been claimed by critics that ill intentions were demonstrated by J & J in their dealing involving this product. It is inconceivable for a company which has been in existence for decades and with thousands of products not to be aware of this regulation.
It has been suggested by some sectors that J & J took this course of action in order to circumvent regulations governing new devices. As a treatment for POP and SUI, Ethicon claimed that the Prolift was a new and unique device. During their launching in March 2005, they even touted this product as an innovative and effective surgical option for weakened pelvic muscles.
One cannot help but ask how it can be similar to an existing product when the Prolift was supposed to be new and unique. This product cannot have a predicate if indeed it was an original device and therefore cannot use the 510(k) prenotification process which requires substantial equivalency.
Taking this course of action may lead one to think that J & J intended to escape the requirements asked for new devices in accordance with the premarket approval process. Savings in time and thousands of dollars for the clinical trials would be made by taking this action.
Unfortunately, a lot of women have been exposed to tremendous risks resulting to pain and agony because of these actions. And to think that all these were meant to rake in millions of dollars and to beat the competitors. Based on the events currently happening will all those lawsuits, J & J may end up paying billions of dollars and having a tarnished name.
References:
meshmedicaldevicenewsdesk.com/latest-in-the-litigation-concerning-mesh-and-medical-devices
bloomberg.com/j-j-sold-vaginal-mesh-implant-after-sales-halt-ordered
