Reacting to organized calls for either a ban or another type of restriction on the transvaginal mesh procedure, the American Urogynecologic Society issued a statement March 26 opposing infringements on such “[i]ndividualized treatment decisions” that “should be made between patients and their surgeons.”
The transvaginal mesh is still approved by the U.S. Food and Drug Administration. It is “permanently implanted to reinforce the weakened vaginal wall to repair pelvic organ prolapse or to support the urethra to treat urinary incontinence,” according to the FDA’s July 13, 2011, safety communication, to which the society refers.
Pelvic organ prolapse happens when organs such as the bladder, the uterus, the rectum, the top of the vagina after a hysterectomy, and the bowel bulge into the vagina. Stress urinary incontinence involves the leakage of urine during coughing, sneezing, laughing, exercise or another physical activity.
Transvaginal mesh lawsuits have been filed by plaintiffs who claimed that their agonizing complications were attributable to mesh implantation.
A part of the professional society’s statement reads as follows: “In July 2011, the FDA released a safety communication and white paper on transvaginal surgical mesh to highlight the potential benefits and risks associated with this therapy. Since that time, a few groups including a state medical organization, a healthcare system and a malpractice insurance company have considered restricting or have banned its use. Such restrictions were never the intent of the FDA safety communication nor do they represent the findings of the FDA Advisory Panel.”
The society’s statement goes on to advocate in favor of continuing to permit pelvic disorder patients and physicians to have full treatment latitude. It reads, “The AUGS position statement notes that it is essential for patients and their surgeons to have access to a full range of both non-surgical and surgical options and to have an open discussion during the informed consent process regarding the likely benefits as well as the potential risks of all options. In some instances, transvaginal mesh for POP may be the most appropriate surgical option, such as in high-risk patients with recurrent prolapse or those with medical conditions where a more invasive and lengthier procedure may be more dangerous.”
This space is not about the right to treatment options. This space is about the right to compensation for those women whose injuries are associated with the transvaginal mesh kit procedure. Their treatment option was damaging.
Such injuries can be serious. And juries have been known to take them seriously. Indeed a New Jersey jury in February ordered Johnson & Johnson to pay a plaintiff in a transvaginal mesh lawsuit more than $11 million in combined punitive and compensatory damages.
In its 2011 safety communication, the FDA explained that transvaginal mesh adverse event reports had soared.
“In the Oct. 20, 2008, FDA Public Health Notification, the number of adverse events reported to the FDA for surgical mesh devices used to repair POP and SUI for the previous 3-year period (2005-2007) was ‘over 1,000,’” the FDA wrote in 2011. “Since then, from Jan. 1, 2008, through Dec. 31, 2010, the FDA received 2,874 additional reports of complications associated with surgical mesh devices used to repair POP and SUI, with 1,503 reports associated with POP repairs and 1,371 associated with SUI repairs.
“Although it is common for adverse event reporting to increase following an FDA safety communication, we are concerned that the number of adverse event reports remains high.”
The FDA also reported to health care providers and to patients in its 2011 alert that the “FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008.”
In a news release issued on the same day in 2011 that the safety communication was promulgated, the FDA explained that the “most frequently reported complications from surgical mesh used to repair POP include mesh becoming exposed or protruding out of the vaginal tissue (erosion), pain, infection, bleeding, pain during sexual intercourse, organ perforation from surgical tools used in the mesh placement procedure, and urinary problems. Some reports cited the need for additional surgeries or hospitalization to treat complications or to remove the mesh.”
When problems arise, transvaginal mesh complications can lead to “surgery, sepsis, severe pain requiring mesh removal or long term narcotics,” according to a report that the FDA’s Transvaginal Mesh Working Group submitted Sept. 8, 2011, to a meeting of the agency’s Obstetrics and Gynecology Devices Panel.
Upon a review of literature concerning transvaginal mesh complications, the working group also reported to the devices panel that it agreed with the FDA “that these literature articles identify the adverse events associated with the treatment of POP using transvaginally placed mesh kits.”
Actually, the procedure predates the kit. The working group briefed the panel that although the transvaginal mesh was “first reported for urogynecological procedures” in 1996, in 2002 “the idea of creating kits similar to transvaginal tape kits used to treat stress urinary incontinence emerged, and the first transvaginal mesh ‘kit’ to treat POP became commercially available. Mesh kits contain the pre-shaped mesh implant(s) as well as the accessory tools needed for transvaginal placement of the device.”
So the transvaginal mesh kit procedure, identified as a key source of escalating adverse events reported to the FDA, had been on the market several years without a proper warning about serious injuries that may result — complications about which the manufacturer had a duty to know and to warn, plaintiffs in transvaginal mesh lawsuits may claim.
The medical and legal professions have essential roles.
For instance, the society noted that its members are “working closely with the FDA, the National Institutes of Health and the American College of Obstetrics and Gynecology to develop robust mechanisms to continue to monitor the safety and effectiveness of transvaginal surgical mesh.”
Meanwhile, pharmaceutical injury lawyers have been investigating the claims of women who may have been harmed by the transvaginal mesh kit procedure, defending the victims’ right to the compensation they deserve.
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The transvaginal mesh attorneys at Reich & Binstock, who operate in every state, do just that, and at no charge they provide initial legal advice as to an entitlement to compensation. For a free consultation, one may call Reich & Binstock toll-free at 1-866-LAW-2400 or they may visit www.reichandbinstock.com to submit an electronic request for a free-of-charge case evaluation.