Vaginal Mesh Marketed by Johnson & Johnson Without FDA Approval
Johnson & Johnson sold their Gynecare Prolift vaginal mesh device for three years before the device was approved by the FDA. Now, the Gynecare Prolift vaginal mesh implant has become the subject of more than 500 dangerous medical device lawsuits.
Though the FDA was made aware of the Prolift in 2007, records show that Johnson & Johnson’s Ethicon unit began to sell the transvaginal mesh in March 2005. The device was not actually approved by the FDA until May 2008.
Johnson & Johnson is the second largest maker of health care products in the world. Representatives from the manufacturer claimed that they could legally market the Gynecare Prolift because it was very similar to a device that was already approved, the Gynecare Gynemesh. In an email published on March 16, FDA spokeswoman Morgan Liscinsky stated that the “FDA disagreed with this assertion” and that Johnson & Johnson distributed the vaginal mesh “without appropriate” clearance.
Experts predict that these unauthorized sales of Gynecare Prolift will inflate the costs J&J will have to pay to settle hundreds of lawsuits. This is not the first time Johnson & Johnson has fallen under fire for manufacturing potentially defective medical devices: they have faced recalls of a number of over-the-counter drugs and prosthetic hips. Furthermore, Johnson & Johnson units have admitted guilt in claims of bribery and illegal drug marketing.
According to attorney Adam Slater, currently representing more than 100 women in suits against J&J, “Even though Johnson & Johnson (JNJ) supposedly lives by a credo to put the patient first, this is an example of fast-tracking a product to market quickly rather than going to the FDA first.”
Some are using this complaint against Ethicon to point out perceived flaws in the FDA approval system. Currently, companies may introduce products without human testing if the FDA has ruled that said products are similar to devices currently on the market.
The FDA has also been the subject of criticism in light of a number of high-profile recalls, such as the recall on Johnson & Johnson’s 93,000 prosthetic hips in July 2007.
According to records, the FDA did not learn of the Gyencare Prolift until Johnson & Johnson referred to it in July 2007 as a predicate in an attempt to gain approval for a future device, the Prolift+M.
Matthew Johnson, Ethicon spokesman, states, “Throughout this process, our actions were responsible, appropriate and consistent with FDA regulations. Numerous clinical studies suggest that when combined with proper surgical technique, surgical mesh can improve patient outcomes, and Ethicon’s devices are among the most studied devices on the market for this condition.”
Andrew Sokol, Georgetown University School of Medicine associate professor of obstetrics/gynecology and urology, says of the lack of FDA approval, “That information would have been important for most surgeons. Most surgeons probably would have not used a completely new product if there was no oversight.”
Transvaginal mesh, also known as bladder sling, is used by surgeons to treat women who suffer from pelvic organ prolapse (POP) or stress urinary incontinence (SUI).
In an FDA report, a five-times increase was noted in deaths, injuries, or malfunctions in relation to vaginal mesh used to treat pelvic organ prolapse. As a result of urging by an advisory panel that the FDA reclassify vaginal mesh as a “high risk” device that would require human testing, the regulatory agency has ordered that a number of makers of vaginal mesh study side effects and complications linked to these products.
At the center of this dispute are Johnson & Johnson’s actions regarding the differences between three products: the Gynemesh Prolene Soft Mesh, the Prolift and the Prolift+M. Gynemesh (approved in 2002) and Prolift are both made of the same nonabsorbable polymer, and the Prolift is distributed in a kit that includes pre-cut mesh and surgical instruments.
In a 2007 application for approval of the Prolift+M, Johnson & Johnson alleged that the Prolift was an “insignificant change” when compared to the previously approved Gynemesh under the 510(k) process.
However, an FDA reviewer assigned to the case in 2007 determined that the devices were not similar enough for this purpose, and that Ethicon should have submitted a separate 510(k) for Prolift. Information in support of Prolift safety and effectiveness was submitted, and both devices were subsequently approved.
Penalties for companies that market non-FDA approved devices may include warning letters, seizure of these devices, and financial penalties or injunctions.
Liscinsky stated regarding these penalties that the ““FDA typically would not take these actions against companies that relied in good faith -- albeit mistakenly -- on agency guidance. But absent this reliance, or in response to repeated mistakes, these actions might follow.”
Before Prolift was approved by the FDA in 2008, the FDA had received 123 complaints of injuries associated with the product since its release in 2005.
The vaginal mesh lawsuits pending against Johnson & Johnson have been consolidated in state court in Atlantic City, New Jersey. Superior Court Judge Carol Higbee presides over those cases.
More than 150 federal lawsuits against vaginal mesh manufacturers, including Johnson & Johnson, C.R. Bard, Boston Scientific, and American Medical Systems, have been consolidated into a multidistrict litigation (MDL) under U.S. District Judge Joseph R. Goodwin. A lawyer working in defense of victims harmed by unapproved vaginal mesh products has stated that he has interviewed a number of physicians who were not informed of this lack of approval.
Contact a Dangerous Medical Device Lawyer
If you or a woman you love was harmed after being implanted with a vaginal mesh product, you may be able to file or join a dangerous medical device lawsuit in pursuit of just compensation for your damages. Contact an experienced product liability lawyer to discuss your rights in a free legal consultation.