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What other alternatives are out there to surgically treat stress urinary incontinence and/or pelvic organ prolapse?
Why is this question relevant if you already have a mesh implant? There is no unavoidably unsafe argument in a design defect case if you can show there are alternative designs to treat the condition.
Indeed, an alternative design is considered as “highly probative” of the existence of defect in the “typical” design defect case.
The Tincher court viewed the Third Restatement as another variant of the “combined” approach, folding consumer expectation principles into an overall risk/utility approach. Id. at 104 (“a variation upon those tests primarily based upon a risk-utility determination by requiring proof of a reasonable alternative design”).
Generally, in Pennsylvania, negligent design cases have required proof of alternative designs. “The determination of whether a product was negligently designed turns on whether an alternative, feasible, safer design would have lessened or eliminated the injury plaintiff suffered.” Berrier v. Simplicity Manufacturing, Inc., 563 F.3d 38, 64 (3d Cir. 2009) (emphasis original).
Alternative design as an essential element of negligent design claims appears to be the general rule around the country in prescription medical product cases. Numerous drug/device decisions require that plaintiffs must plead and prove a feasible alternative design to prevail on a negligent design claim.
In non-drug/device contexts, most jurisdictions require plaintiffs to plead and prove a feasible alternative design to prevail on a negligent design claim. New Jersey – N.J. Stat. §2A:58C-3 (requiring “a practical and technically feasible alternative design” in all design-related product liability actions); Kass v. West Bend Co., 2004 WL 2475606, at *12 (E.D.N.Y. Nov. 4, 2004) (in New Jersey “there is no separate cause of action grounded in negligence” and all design claims turn on “proof by plaintiff of a ‘reasonable alternative design”), aff’d, 158 F. Appx. 352 (2d Cir. 2005).
We often see plaintiffs plead both strict liability design defect and negligent design to increase their odds of some claim surviving. In many jurisdictions, the theories don’t differ much at all, because they rely on the same set of facts, are subject to the same analysis and tend to produce the same results.
Under New Jersey law, a plaintiff in a design defect action generally must provide evidence of a safe and reasonable feasible alternative design. Smith v. Keller Ladder Co., 645 A.2d 1269, 1271 (N.J. App. Div. 1994) (risk-utility analysis “ordinarily involves the consideration of available alternatives”).
Smith goes on to state that “unless there is some basis for a jury to find that the risks involved in a product’s use outweigh its utility even though there is no reasonably feasible alternative design, a plaintiff in a design-defect case is required to show the existence of a safe and reasonably feasible alternative to [the] defendant’s product.” Id. at 1271 (citing N.J.S.A. 2A:58C-3(a)(1) (“A manufacturer may not be held liable in a design-defect product liability action “if ... [a]t the time the product left the control of the manufacturer, there was not a practical and technically feasible alternative design that would have prevented the harm without substantially impairing the reasonably anticipated or intended function of the product”)).
The trial court in the Carlino case instructed the jury: The plaintiff is also required to prove the existence in August 2005 of a reasonably feasible alternate design unless the risk[s] involved in the TVT’s use outweigh its utility even though there is no reasonably feasible . . . alternative design. A design defect exists if the foreseeable risk of harm posed by the TVT could have been reduced or avoided by the adoption of a reasonable safer design and the omission of the alternate design renders the product not reasonably safe.
If the failure to incorporate a practical and technically feasible safer alternate design made the TVT not reasonably safe, then the TVT was designed in a defective . . . manner . . . If, on the other hand, plaintiff has not proven there existed a practical and technically feasible safer alternative or if you find that the TVT as designed was reasonably safe, then the product was not designed in a defective manner.
In April of 2019, the Superior Court stated that the Carlinos introduced evidence that reasonably feasible alternatives to the TVT design were available in 2005. Dr. Klinge testified that Ethicon could have used either (1) macroporous Ultrapro or Vypro as the mesh in the TVT; (2) a different polymer; or (3) the different technique of lasercutting mesh. The Carlinos’ counsel fairly argued this evidence to the jury in closing argument. Tr., 2/9 (AM), at 107-12; Tr., 2/9 (PM), at 59-69. Accordingly, Ethicon’s objection to the jury instruction on design defect was found to be devoid of merit.
Before electing to undergo transvaginal surgical mesh implantation to treat POP or SUI, patients should be aware that a variety of alternative treatments exist.
Surgery to repair POP or SUI does not necessarily require a mesh implant. Burch urethropexy is a surgical procedure that utilizes sutures to provide support to pelvic organs. It is, however, more complicated and invasive than mesh implantation, and some studies have demonstrated low long-term success rates. One study, which examined 66 women who underwent the procedure to correct SUI, found high rates of suture erosion. Half the women in the sample required revision surgery while less than a third reported that their condition improved.
Sacrocolpopexy is considered the “gold standard” in treatment of POP by many surgeons. Most commonly used in the case of vaginal vault prolapse, it, too, involves the implantation of a small piece of mesh to support pelvic organs. Surgery, however, is performed through incisions in the abdomen rather than the vagina.
There are two disadvantages to sacrocolpopexy to treat POP. The conventional form is significantly more invasive than transvaginal implantation, and can involve a recovery time of six weeks or more.
Minimally invasive laparoscopic (keyhole-incision and camera-assisted) and robot-assisted approaches exist as an alternative to standard abdominal sacrocolpopexy, but they are more expensive because of the specialized equipment involved. Nonetheless, the long-term success of sacrocolpopexy is found to be as high as 90 percent, according to some studies.
Additionally, a number of nonsurgical treatments may provide relief from POP and SUI, including:
Pelvic floor exercises (Kegels): In some cases, exercising the pelvic muscles can strengthen the pelvic floor sufficiently to provide support for prolapsed pelvic organs.
Pessary: A pessary is a removable device that can be non-surgically inserted into the vagina to provide support for pelvic organs.
Transurethral bulking agents: Though not always permanent, the area around the urethra may be thickened with the help of collagen injections, helping to control urine flow.
Behavioral modification: Patients with SUI may find that behavioral modification can help them successfully avoid actions that lead to urinary leakage.
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