Recently, plaintiffs from the State of California filed a lawsuit to the Attorney General of the State of California against Johnson and Johnson and Ethicon Inc. The use of vaginal mesh devices and the related complications in women unified people to voice their complaints against one of the largest multinational medical device manufacturers, Johnson and Johnson.
It was in the year 2002 when Johnson and Johnson introduced its first surgical vaginal mesh device to repair pelvic organ prolapses (POPs) and stress urinary incontinences (SUIs) in women.
Vaginal mesh is a medical device made out of synthetic polymer threads of polypropylene. When it is implanted into a woman’s system through the vagina, it is called a transvaginal mesh.
Vaginal mesh implantation is used for an array of medical conditions which result due to the weakening of pelvic muscles. Two of the most common medical conditions as stated above, are POPs and SUIs.
- Pelvic Organ Prolapse (POP): In this condition, a woman’s pelvic organs which may include; the urethra, uterus, small intestines, vagina, rectum and bladder, drop down from their normal abdominal place to the lower cavity, pushing through the walls of vagina. This is followed by the weakening of the pelvic muscles of a particular pelvic organ which help keep the organ in place. Many women suffer from this condition where they feel pressure, pain and discomfort in their lower abdominal area.
Pelvic organ prolapse is a condition which is often followed by multiple childbirths or hysterectomy (uterus removal). Both childbirth and hysterectomy cause weakening of the pelvic muscles increasing the likelihood of POP. Obesity, consistent constipation, persistent coughing and tumors in pelvic organs are some of the conditions which could also work as secondary risk factors in increasing the condition.
- Stress Urinary Incontinence (SUI): It is a medical condition caused by the weakening of pelvic muscles that support the bladder and urethra, in particular. In this condition, involuntary urine excretion is experienced by the sufferer. Urine leakage can occur while performing physically strenuous tasks. It can also take place in situations when pressure is exerted on the lower abdomen, such as during sneezing, coughing or laughing. SUI can coexist with POP and get worse. Other risk factors include menopause, childbirth, connectivity tissue disorders and obesity, all of which contribute to the likelihood of SUI.
The conditions are certainly troublesome but they are not life-threatening in nature. However, to cure these conditions, surgical and non-surgical treatment procedures are widely available. The most commonly used surgical procedure in this context is vaginal mesh implantation which is a permanent treatment given through surgery.
Among a few other vaginal mesh product manufactures, Johnson and Johnson is the leading company whose products are widely used. Vaginal mesh product manufacturers claim this treatment modality to be the safest, most effective and minimally invasive method to treat the problem.
On the other hand, the complainants have negated these claims in their lawsuit. The women who opted for vaginal mesh implantations reported many complications after undergoing the surgery. The highlighted complications included chronic pelvic pain, permanent urinary and defecatory dysfunction, and loss of sexual functions. It was even more appalling when it was found that the nature of these complications could be irreversible for many women. This has led to serious issues that involved disrupted quality of lives for women and ruined marital/sexual relations. In many cases, a permanent disability and inability to work was also reported.
The plaintiff alleged that Johnson and Johnson hid all of these potential risks from doctors and patients alike while marketing their product. Doctors were complaining that such important information was concealed from them and that they were misled towards proposing vaginal mesh implantation as a potential treatment for the affected women.
Other doctors said that they were not told about the potential hazards of the treatment and that their patients were asked to become clinical trial participants for a procedure which could have lifelong side effects. As the company hid potential risks, the women were denied the right to making an informed decision about their health, which in itself is a criminal act.
The treatment, being permanent in nature, led to increasing complications for women who underwent multiple mesh removal surgeries to get rid of the grave mesh implantation consequences.
The lawsuit also claimed that authorities at Johnson and Johnson were well aware of the above stated medical risks. Their own medical experts and advisors urged them not to go forward with commercializing their product, but their efforts went in vain.
It is worth noting that the lawsuit made another serious allegation regarding Johnson and Johnson, stating that they had marketed their product as FDA approved. However, according to the lawsuit claim, this was not the case. They claimed that the FDA had cleared the product under the 510 (K) equivalency process, which was far from being approved.
Speaking of the FDA, earlier this year, the FDA reclassified vaginal mesh devices as high-risk devices after receiving complaints. British Medical Journal (BMJ) reports that nearly 790,000 vaginal mesh devices were sold in the US, while over 2 million products were globally sold. Amongst users in the US, product sales were high in the California and Washington states. This led these two states to initiate an investigation on behalf of other 46 states as well.
With about 35,000 lawsuits awaiting their verdict against Johnson and Johnsons, the company is vulnerable to a potentially huge loss. Lately, Johnson and Johnson had been in limelight, due to the controversy surrounding the causative use of J&J talcum powder, which lead to ovarian cancer.
As many as 1200 lawsuits were filed against this complaint alone, with two court verdicts going in favor of the complainants against the company in the US. In addition to the huge monetary stress faced by the company it damaged the global reputation of Johnson and Johnson badly. With the surfacing of this new controversy, it is high time that the authorities at Johnson and Johnson prudently strategize their future moves.