Pelvic mesh, again.

Last April I wrote about the FDA’s decision to ban the use of surgical mesh devices for transvaginal repair of pelvic organ prolapse (“transvaginal mesh” or “pelvic mesh”).  Of course, because transvaginal mesh was used for that purpose for 14 years (2002-2016), the resulting litigation isn’t over yet.  The most recent case to come to my attention is Kaiser v. Johnson & Johnson and Ethicon, Inc., (7th Cir. 1/14/20).  Ethicon manufactured the mesh product at issue in this case and marketed it under the brand name Prolift.  The case is noteworthy for its lucid, detailed explanation of the process by which the FDA cleared Prolift (and similar pelvic mesh products from other manufacturers) for sale.  It is disheartening to learn, thanks to that explanation, that the process in question involves no safety review whatsoever.  The opinion is well worth reading in its entirety, and I urge interested attorneys to do so, but here’s the heart of it (emphasis added):

The Medical Device Amendments of 1976 (“MDA”) establishes the framework for federal regulation of medical devices….The particulars of the premarket approval process aren’t important here; it’s enough to note that it requires extensive submissions by the device manufacturer and a thorough review by the FDA.  The FDA has broad discretion to withhold approval throughout the process….[However,] post-1976 devices can escape rigorous premarket review through the MDA’s “premarket notification” process.  Almost every manufacturer of a new device must submit a notification to the FDA at least 90 days before marketing the device….The FDA may clear a device for sale without premarket approval based on this notification [under either of two circumstances].  First, the MDA exempts from premarket review any device that receives what’s known as a “§ 510(k) clearance” from the FDA.  To get this clearance, a device must be “substantially equivalent” to either a pre-1976 device that the FDA hasn’t yet classified or a Class I or II device already on the market.  Most medical devices enter the market through this exception….

[T]wo of the three ways for a new device to be substantially equivalent to a predicate device have nothing to do with product safety….Second – and more pertinent to Prolift – the FDA can clear a device if it has “the same technological characteristics as [a] predicate device.”  This comparison does not consider safety….Underscoring the distinction between safety and similarity of technological characteristics, the FDA does not generally require safety information in a § 510(k) substantial-equivalence premarket notification.  Finally, the MDA’s authorization of “piggybacking” – clearing a device based on its substantial equivalence to a predicate device that itself received clearance through substantial equivalence – increases the gulf between § 510(k) clearance and comprehensive safety review.  Through piggybacking, a medical device moves incrementally further and further away from the “original” predicate device that the FDA actually classified.

In light of these features of the system, it’s no surprise that the FDA has promulgated a disclaimer that § 510(k) clearance “does not in any way denote official approval of the device.”  Id. § 807.97.  In fact, it’s unlawful for a device manufacturer to make such a representation.  See id.  (“Any representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding.”); see also O’Reilly & Van Tassel, supra, § 18.22, at 464 (“It is important to note that in the § 510(k) process, the device is not officially approved by the FDA as being safe and effective.”).  [Citations omitted except in the last paragraph; most internal quotation marks omitted.]

Ethicon received a § 510(k) substantial-equivalence clearance for Prolift in 2007, using the piggybacking method – i.e., based on Prolift’s technological similarity to transvaginal mesh devices that had themselves received clearance through substantial equivalence.  Amazingly, as the opinion in this case reveals, the “original” predicates for all of those piggybacked devices were a group of surgical meshes that the FDA classified in a 1988 rulemaking – 14 years before the FDA gave the first § 510(k) clearance to a pelvic mesh device in 2002!  The short of it is, the FDA allowed several manufacturers to market transvaginal mesh to treat pelvic organ prolapse, based on prior approval of other surgical mesh devices that were used for entirely different purposes, all without any safety review whatsoever of any transvaginal mesh device.  Only after years of complaints from patients and physicians about severe complications resulting from the use of pelvic mesh, plus the filing of thousands of lawsuits (tens of thousands by now), did the FDA required the manufacturers to begin postmarket surveillance in 2012.  Then it took 4 more years for the FDA to suspend the marketing of surgical mesh for transvaginal repair of pelvic organ prolapse pending further review, which finally led to the ban on such use last April.

The plaintiff’s experts in the Kaiser case were urogynecologists – a subspecialty of gynecology also known as female pelvic medicine & reconstructive surgery.  Vident Partners has access to excellent urogynecologists around the country.  If you need a urogynecologist to serve as an expert witness in a pelvic mesh case – indeed, if you need an expert in any field for any type of litigation – we stand ready to assist you.


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