Transvaginal Mesh Recall?

Should all transvaginal mesh products be recalled?

It is a fair question. These products – and we see juries starting to prove this point – are a train wreck.  These companies – all of them, it seems – were chasing profits and ignoring the harm they were causing women.  It really is as simple as that.

A more complicated issue is whether the FDA should recall vaginal mesh products altogether. The classic plaintiffs’ lawyer knee jerk response is, “Of course!”  The real world is a little more complex.

Plaintiffs’ attorneys are prone to making rash statements like “This product should be banned!” without really considering all the public health ramifications.

The History of the Vaginal Mesh Nightmare

First, a brief history of this mess. The FDA first alerted medical providers about the serious complications associated with surgical mesh placed through the vagina (transvaginal placement) to treat POP and SUI in October 2008.  Truthfully, the FDA was late to the party: plaintiffs’ lawyers had long known these products were fatally flawed. In 2011 the FDA updated its warning to state that, “serious complications associated with surgical mesh for transvaginal repair of POP are not rare.” Moreover, the FDA warned that transvaginal repair with mesh was not shown to be more effective than traditional non-mesh repair in all patients and might expose patients to greater risks.

FDA Recommendations

This 2011 FDA Safety Communication also provided health care providers and patients with updated recommendations for the use of surgical mesh. These recommendations include that health care providers recognize that in most cases, POP can be treated successfully without mesh and that patients choose to undergo mesh surgery only after weighing the risks and benefits of surgery with mesh versus all surgical and non-surgical alternatives. The FDA also recommended that medical providers “consider these factors before placing surgical mesh:

• Surgical mesh is a permanent implant that may make future surgical repairs more challenging.
• A mesh procedure may put the patient at risk for requiring additional surgery or for the development of new complications.
• Removal of mesh because of mesh complications may involve multiple surgeries and significantly impair the patient’s quality of life. Complete removal of the mesh may not be possible and may not result in complete resolution of complications, including pain.
• Mesh placed abdominally for POP repair may cause lower rates of mesh complications compared to transvaginal POP surgery with mesh.
• Inform the patient about the benefits and risks of non-surgical options, non-mesh surgery, surgical mesh placed abdominally and the likely success of these alternatives compared to transvaginal surgery with mesh.
• Notify the patient if the mesh will be used in her POP surgery and provide the patient with information about the specific product used.
• Ensure that the patient understands the postoperative risks and complications of mesh surgery as well as limited long-term outcomes data.”

American Urogynecologic Society’s Position on the Recall/Ban

My gut-level reaction would be to just recall every transvaginal mesh product out there and ban this garbage altogether.  The American Urogynecologic Society (AUGS) issued their “Position Statement on the Restriction of Surgical Options for Pelvic Floor Disorders” on March 26, 2013.  These folks don’t have a dog in the fight other than women’s health and safety, so they are worth listening to on this issue.

AUGS opposes a recall or restrictions on the use of pelvic mesh as a surgical option. AUGS’ Position Statement argues that a complete ban on the mesh was not the intent of the FDA’s Safety Communication. AUGS states that the decision to use surgical mesh should be left to the doctor and patient, and a ban on the use of mesh may prohibit some patients from getting the most appropriate treatment for their situation. Particularly, there are some patients, such as those with recurrent anterior compartment prolapse, where transvaginal mesh surgery is the best option. Because the FDA did not recall surgical mesh, AUGS feels that banning mesh will prohibit the surgical studies mandated by the FDA. The FDA mandated that manufacturers of currently approved devices enroll patients into post-market research studies about the efficacy and safety of these procedures.

In addition, AUGS states that the FDA did not include mesh slings for SUI in the 2011 FDA warning. AUGS’ Position Statement argues that: “Full-length midurethral slings, both retropubic and transobturator, have been extensively studied, are safe and effective relative to other treatment options and remain the leading treatment option and current gold standard of care for stress incontinence surgery.”

The fear here is clear. A ban on the mesh, according to AUGS, would have a chilling effect on research in this area and would severely limit the advancement of science and future innovations that could significantly help women develop technologies that actually work. AUGS is saying to give doctors and patients a choice and don’t pull options off the table.

Reluctantly, this makes sense to me. While I think these products are not safe, we have to recognize that there are some women that have absolutely no other options. Some of these products should be made available to them with appropriate warnings and an honest assessment of the risks involved and that the product should only be used if there is no other possible choice. When possible, the mesh should be surgically placed abdominally rather than vaginally to lessen the risks of complication.

Hiring a Lawyer for Your Vaginal Mesh Claim

Our firm is committed to protecting the rights of women injured by unsafe vaginal mesh products.  Along with other plaintiffs’ lawyers around the country, we believe these companies should be held accountable.  If you believe you have a potential claim, call 888-322-3010, or get a free online consultation.