Johnson & Johnson and its Ethicon division have reached a deal with the attorneys general of 41 states and the District of Columbia, agreeing to settle claims that it deceptively advertised and marketed its transvaginal mesh products that caused severe and permanent injuries to women. The companies will pay nearly $117 million as part of the mesh lawsuit settlement.
The states’ attorneys general said that a multistate investigation found J&J and Ethicon had “misrepresented or failed to adequately disclose possible adverse effects” to patients and surgeons. It is alleged that the company was aware of the risks of serious complications from the implants. Synthetic transvaginal mesh has been used for many years now to provide additional support to women’s pelvic organs and to help repair pelvic organ prolapse and stress urinary incontinence.
Serious Complications for Women
These vaginal mesh implants were soon causing problems for many women who received them because they were coming apart inside women’s bodies, causing inflammation, chronic pain, and infections. Many women who sued transvaginal mesh implant manufacturers said their quality of life was so significantly altered that some could not even continue to work or engage in sexual intercourse.
Women reported having problems with everyday activities such as sitting, walking, or participating in other activities. These complications were so unbearable that many plaintiffs who filed a mesh lawsuit against manufacturers said they were willing to endure multiple revision surgeries to remove the implants. But even that was not sufficient to give them relief from the pain and discomfort because the mesh was so deeply embedded in the vaginal wall that it was impossible to extract.
Problems reported in lawsuits include:
- Mesh erosion: This is when the implants cause damage to the vaginal walls or internal organs.
- Infection: Pathogens can grow on implants and cause serious infections
- Pain: The device may damage nerves and cause scarring and pain during intercourse.
- Urinary problems: The devices may also make it difficult to urinate or make urination painful.
- Recurring prolapse or incontinence: A failed implant could cause recurring prolapse or stress urinary incontinence – the very issues the implants were supposed to fix.
Ethicon was previously ordered by a Philadelphia jury last May to pay $80 million to a woman who suffered serious complications after a procedure in 2008. That mesh lawsuit verdict included $50 million in punitive damages related to J&J’s descriptions of the product’s risks. A month before, in a separate but similar finding, a Philadelphia court awarded another woman a $120 million verdict.
Thousands of mesh lawsuits have leveled serious allegations against not just J&J, but other manufacturers of vaginal mesh implants. Allegations include intentionally misleading the FDA, the medical community, patients, and the public about the safety and efficacy of these products. Manufacturers have also been accused of misleading marketing and advertising, failure to do due diligence in terms of testing the devices, and failure to warn patients about potential complications and injuries.
What This Mesh Lawsuit Settlement Means
This most recent $117-million settlement requires J&J, as well as its subsidiary Ethicon, to fully disclose the risks of the transvaginal mesh products. They must disclose that those who get these implants may need revision surgeries to treat complications. The companies are also required under the agreement to ensure that the training they provide to healthcare professionals covers information about those risks. Also, the companies cannot claim in their marketing or advertising material that mesh stretches or remains soft after implantation. They are also not permitted to say that patients “may” suffer “foreign body reactions” when studies show they do occur and have the potential to cause permanent damage.
The settlement also instructs J&J and Ethicon to refrain from referring to the vaginal mesh products as FDA-approved when that is not the case and to stop claims that the mesh’s risks can be eliminated through surgical experience or technique. While the settlement is expected to be divided among the states in varying amounts, it does not include admissions of liability or misconduct. Lawsuits brought by other states, including here in California, are still pending and involve thousands of injured plaintiffs.
J&J and Ethicon previously stopped sales of mesh implants in 2012. This year, the Food and Drug Administration ordered Boston Scientific and Coloplast to stop selling their vaginal mesh implants nationwide. In April, the FDA said it determined the mesh was not proven safe and effective for the treatment of pelvic organ prolapse after getting reclassified in 2016 as a high-risk (Class III) medical device.
Seeking Compensation for Your Losses
If you or a loved one has been injured as a result of these dangerous and defective medical devices, you may be able to seek compensation for losses, including medical expenses, lost income, cost of surgeries, hospitalization, permanent injuries, disabilities, scarring, compromised quality of life, pain and suffering, and emotional distress. An experienced California product defect lawyer and class action attorney who deals with transvaginal mesh legal cases will be able to advise you regarding your legal rights and options.