Product Liability Lawyer Blog
In the greater Boston area and across the United States, women have been filing lawsuits against makers of defective transvaginal mesh (TVM) medical devices in large numbers.
According to a recent news article from WBUR, there has been no slowdown of victims coming forward to file cases. Transvaginal mesh implants are used to support sagging pelvic organs and hold them in place. They have been market as a way for women with bladder control issues and other pelvic issues to lead a normal life again, but this is not how it worked out for many victims.
Defectively designed tranvaginal mesh implants have led to serious, painful and often embarrassing medical conditions known as pelvic organ prolapse (POP) and stress urinary incontinence. To make matters worse, doctors have found removing a defective transvaginal mesh implant may not help to fix the damage, because much of it was due to erosion of the vaginal wall while the device was implanted.
Extensive medical research has shown after a defective transvaginal mesh implant is removed, around half of patients suffering from pelvic pain did not experience a complete, or in some cases even partial, improvement of their condition, pain and suffering.
The most prevalent symptom of a defective transvagnial mesh implant was persistent pain, which was also the least likely to completely subside after the defective medical device was removed.
Awareness of these problems associated with TVM implants has led to a significant reduction in the number of devices implanted each year, but they are still being presented as an option for patients at high risk for failure of traditional surgical intervention methods used to treat female pelvic issues. Even for these patients, surgeons must tell patients that serious side effects such as erosion of the vaginal wall are not rare, as defined as the United States Food and Drug Administration (FDA). In other words, there is a decent chance a patient will experience these problems.
It should be noted these extra warnings from surgeons are not always given. This is because transvaginal mesh manufacturers spend great amounts of money in marketing their devices as safe and effective alternatives to traditional surgical techniques. Medical device manufacturers have also taken steps to keep knowledge of these dangers from the FDA, surgeons, and prospective patients.
As our Boston transvaginal mesh injury attorneys can explain, there are primarily two claims raised in these types of lawsuits. The first, and most obvious, is manufacture of a defective medical device. This claim can be established by showing a company knew or should have known they had designed and marketed a defective product. Proof of this can be established by a showing companies chose not to perform necessary clinical trials and safety testing or failed to inform the FDA of known issues.
The second type of claim typically brought in these personal injury lawsuits involves failing to adequately warn surgeons and patients of known risks. Obtaining a patient’s consent to undergo a medical procedure is of utmost importance in our healthcare system. However, it is not only consent, but informed consent doctors must obtain.
Informed consent means a patient has been told of the known risks of a medical procedure and given an opportunity to decide if potential benefits outweigh potential risks. If a patient is not told of possible complications, there is no way she can give her informed consent.
If you are the victim of a defective medical device in Boston, call Jeffrey Glassman Injury Lawyers for a free and confidential appointment — (617) 777-7777.
Additional Resources:
Lawsuits Move Forward, Brought By Women Hurt By Vaginal Mesh, Mar. 10, 2015, WBUR
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FDA Announces Testosterone Meds Must Carry Broader Warning, July 7, 2014, Boston Products Liability Lawyers Blog