Mesh Medical Device News Desk, June 19, 2019 ~ It has not been a good time for mesh maker Coloplast.
The Danish company recently lost its last application to market the Coloplast pelvic organ prolapse (POP) mesh after the U.S. Food and Drug Administration said it hadn’t proven it was superior to a non-mesh repair.
Now Coloplast has confirmed the rumors that its urology division is for sale.
A company announcement earlier this month said Coloplast 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 move comes two months after the U.S. Food and Drug Administration (FDA) determined both Coloplast and Boston Scientific had not demonstrated a reasonable assurance of safety and efficacy over the three remaining pelvic meshes on the market used to support the pelvic floor.
In 2016, the FDA upclassified POP mesh to its highest risk category class III. At the same time it ordered manufacturers to conduct post approval monitoring studies on the health of implanted women.
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 pending the outcome of those post approval (522 ) studies, but the FDA decision meant both manufacturers were ordered to stop selling their devices in the U.S. immediately, closing the door to the last Coloplast mesh on the market.
Restorelle Y mesh is still on the Coloplast website as is the Axis and Suspend biologic grafts, made from cadavers. It can still be placed abdominally and the FDA decision does not affect sales in other countries.
Coloplast is one of the seven companies defending itself against personal injury claims of selling a defective product. At its height, it had 2,717 claims filed in federal court in West Virginia.
Coloplast has settled lawsuits and spent about $744 million, according to its recent company report.
Bloomberg estimates the company could be sold for $1 billion US dollars.
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. Niels Granholm-Leth, with Carnegie, says, "We are surprised it is planning to divest the Urology business; it is the fastest rowing business area in Coloplast and made up 11% of group sales last year."
Besides gynecological mesh, Coloplast sells the a penile implant, the SenSura Mio Ostomy bag, SpeediCath, a male urinary catheter, Biatain Silicone Foam wound dressing, and stents. Coloplast still sells Altis polypropylene mesh to treat stress urinary incontinence.
At one time Coloplast sold four different types of mesh to treat pelvic organ prolapse:
*Novasilk – A synthetic polypropylene vaginal mesh placed transvaginally to treat pelvic organ prolapse including rectocele, enterocele and cystocele as well as vaginal vault prolapse. Novasilk is thin says the maker and “may reduce cases of inflammation, infection, or erosion by having less implanted material.”
*Suspend– made of human biologic material, Suspend is supposed to integrate better into the human body once implanted to treat pelvic organ prolapse.
*Exair – Polypropylene mesh used to reinforce the pelvic floor to treat prolapse.
*Axis – Biologic product extracted from the back and back of legs which is intended to integrate into the human body once implanted to treat pelvic organ prolapse
The company could be sold for $1 billion.
In a similar move, American Medical Systems sold its urology division to Endo International which rebranded it as Astora Women’s Health. Astora closed its doors and stopped selling transvaginal mesh at least in part due to the cost of litigation.
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.
“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 FDA mandated post-approval marketing studies on patients, known by its regulatory name as 522 studies.
In March 2014, Coloplast offered settlements of about $40,000 each to women who had filed defectrive roduct cases in the MDL in West Virginia.
MND, April 16, 2019, FDA Orders Mesh Makers to Stop Stelling Prolapse Pelvic Mesh
MND, April 17, 2019, Pelvic Mesh Remains on the Market Despit FDA Decision
MND, March 4, 2014, Coloplast Reported to Offer $16 million to Settle Transvaginal Mesh Lawsuits
SEC report 2009
Coloplast PDF Female Pelvic Solution for SUI