Mesh Medical Device News Desk, June 23,2019~ Coloplast had nearly 3,000 pelvic mesh cases filed in federal court in West Virginia and had recent disappointing news about its remaining mesh on the market. The doors appear to be closing on its urology division.
It has not been a good time for mesh maker Coloplast.
The Danish company recently lost its last application to market its pelvic organ prolapse (POP) mesh after the U.S. Food and Drug Administration (FDA) failed to approve the last mesh it had on the market saying it had failed to prove it was superior to a non-mesh repair.
Now the company is exploring “an unconditional strategic review of its interventional urology division.”
Translation- it is looking for buyers as it prepares for a potential sale. The reported sales price of the unit - $1 billion.
Image: Coloplast exhibit, American Urogynecologic Society, Denver 2016
Coloplast is the fourth largest manufacturer or urology products. The urology business grew 6% during the fiscal year ending last September bringing in about $276 million in revenue, reports the company. Besides gynecological mesh, Coloplast sells the Titan penile implant, the SenSura Mio Ostomy bag, SpeediCath, a male urinary catheter, Biatain Silicone Foam wound dressing, and stents.
Coloplast has more than 41-thousand shareholders at the end of 2018. Institutional investors based outside of Denmark hold 33% of the company while members of the Louis-Hansen family own about one-third of the company.
Coloplast is one of the seven companies defending itself against personal injury claims alleging it sold a defective pelvic mesh used for incontinence and prolapse.
At its height, Coloplast sold four polypropylene and cadaver pelvic meshes used to treat POP (Exair, Axis, Suspend, and Novasilk) but the complications resulted in 2,717 defective product claims filed in federal court in West Virginia and about about $744 million in settlements, according to its recent company report.
The company had great hopes for its Restorelle DirectFix, its remaining mesh used to shore up the sagging pelvic floor, but in April, the FDA determined both Restorelle and two Boston Scientific meshes, Uphold LITE and Xenform, had not demonstrated a reasonable assurance of safety and efficacy.
This was just the latest hit for an industry trying to find a POP mesh to market. In 2012 when the FDA ordered postmarket surveillance studies, known by its regulatory name as 522 studies, of the mesh devices on the market for incontinence and prolapse, most manufacturers of POP mesh opted to remove them from the market.
The second hit came in 2016 when the FDA upclassified POP mesh to its highest risk category class III from a moderate risk class II.
Boston Scientific was hoping its Uphold LITE Vaginal Support System and Xenform Soft Tissue Repair System, and Coloplast its Restorelle Direct Fix Anterior, could stay on the market but in April, the FDA ordered the companies to immediately stop selling the devices. There appeared to be no improvement over a non-mesh repair at 36 months.
Dr. Jeffrey Shuren, CDRH
“In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP. That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.
Both Boston Scientific and Coloplast must continue to follow-up on their 522 FDA mandated post-approval marketing studies on patients, which are expected to have preliminary results by November.
The Coloplast Restorelle Y mesh is still on the Coloplast website to be used in an abdominal POP placement as is the Axis and Suspend biologic grafts, made from cadavers.
MND, April 16, 2019, FDA Orders Mesh Makers to Stop Selling Prolapse Pelvic Mesh
MND, April 17, 2019, Pelvic Mesh Remains on the Market Despite FDA Decision
MND, March 4, 2014, Coloplast Reported to Offer $16 million to Settle Transvaginal Mesh Lawsuits
Coloplast Annual Report 2017/2018