Surgical mesh was originally designed for hernia repair procedures, but in 1990 Johnson and Johnson (“J&J”) developed, manufactured, and began marketing surgical pelvic mesh implants as a way to treat Pelvic Organ Prolapse and Stress Urinary Incontinence in women. According to the U.S. Food and Drug Administration (“FDA”) in urogynecologic procedures a surgical mesh is permanently implanted to reinforce the weakened pelvic wall, or to support the urethra, or bladder neck. For many women after childbirth, or as a part of aging, the pelvic floor weakens or over stretches allowing for organs to bulge into the vagina and in some extreme cases organs can bulge into the vaginal opening. Organs normally associated with pelvic organ prolapse include the uterus, bladder, intestine, and rectum. Pelvic organ prolapse affects 30 to 50 percent of women with only about 2 percent developing symptoms. Stress urinary incontinence also treated with surgical mesh surgery involves the unintentional leakage of urine caused by sneezing, laughing, coughing, or physical exertion. If you or a loved one were injured as a result of a failure to warn of known complications associated with surgical pelvic mesh implants, a licensed Pennsylvania and New Jersey personal injury attorney may be able to assist you in recovering just compensation for your injuries.
A rather alarming article ran last week in the Philadelphia Business Journal entitled, “Johnson & Johnson accused of destroying records in product injury suits.” The article references a group of advocates and lawyers calling on the U.S. Department of Justice to investigate the alleged destruction of thousands of documents by Johnson & Johnson (“J&J”) in connection with the development of its pelvic mesh implants. This comes on the heels of last months ruling in West Virginia where U.S. District Court Judge Cheryl Eifert held that J&J had destroyed thousands of documents relating to the development of its pelvic mesh implants, but that there was no evidence proving that the act was done intentionally. Corporate Action Network, a nonprofit group that highlights businesses wrongdoings and seeks to hold them accountable, was one of the advocacy groups that wrote to Attorney General Eric Holder asking him to look into J& J destruction of pertinent information regarding the safety of its pelvic mesh implants. Corporate Action Network alleges that J&J knowingly destroyed evidence relating to a federal probe and further obstructed justice. Thousands of cases are pending where women allege that Johnson and Johnson knew that their surgical pelvic mesh implants caused serious complications that they never warned of prior to the implant.
Since the introduction of surgical mesh Johnson & Johnson has developed, manufactured, and marketed several vaginal mesh devices under the subsidiary Ethicon, Inc. Ethicon’s previous versions of surgical pelvic mesh were Gynecare TVT, Gynecare Secur, Gynecare Prosima, and Gynecare Prolift. Currently, Ethicon’s website does not mention any pelvic floor repair products or procedures on their consumer website. One link under women’s health conditions lists uterine prolapse but then takes you to a page about hysterectomies. Interestingly enough on the website geared towards healthcare professionals two pelvic floor repair products are advertised, Artisyn Y-Shaped Mesh and Gynecare Gynemesh PS Prolene nonabsorbable. A recent FDA Safety Communication on Surgical Mesh updated March 18, 2014 warns that while rare, frequent complications associated with surgical mesh used to treat Pelvic Organ Prolapse and Stress Urinary Incontinence, include infection, pain, urinary problems, erosion through the vagina, scaring, and pain during sexual intercourse.
If you or a loved one has suffered a serious injury due to a product liability you may be entitled to compensation for your injuries. If you would like more information regarding personal injury representation, and to determine whether you have grounds for a case, please contact us online or call 1 800 7 LEGAL 7 for a Free Case Evaluation.