Johnson & Johnson (JNJ) grabbed headlines this week for withdrawing from the market power morcellators, manufactured by subsidiary Ethicon, citing “uncertainty” about the “risk-benefit assessment” associated with the device’s use. Just as important was the demonstration that the company is willing, in some cases, to do the right thing. This action renews hope that JNJ will make a similar determination about its pelvic mesh implants, which are also manufactured by Ethicon.
The withdrawn morcellator device is commonly used in uterine surgery to remove fibroids by cutting the tissue into tiny pieces and extracting it through small incisions. Uncertainties about the device’s safety surfaced in April 2014, when the FDA issued a safety communication stating that morcellators could spread cancerous tissue in women with undetected cancer, presenting a risk that the procedure could “significantly worsen the patient’s likelihood of long-term survival.”
Clearly, this device presents a danger to patients, and JNJ was right to voluntarily withdraw it from the market. Still, the decision raises questions about the company’s handling of a product manufactured by the same subsidiary and intended for the treatment of common pelvic disorders in women: pelvic mesh.
Criticism of pelvic mesh is not new. Three of the largest manufacturers of pelvic mesh face more than 65,000 lawsuits, with JNJ’s subsidiary Ethicon accounting for more than half of this total.
A July 2011 FDA Safety Communication identified the frequent complications associated with pelvic mesh, including mesh erosion through the vagina, pain, infection, bleeding, organ perforation, and urinary problems. The safety communication specified, “Many of these complications require additional intervention, including medical or surgical treatment and hospitalization.” Far from conveying ‘uncertainty’ about the dangers of pelvic mesh, the FDA also stated that serious complications are “not rare."
New Brunswick, New Jersey, April 2014
Last week, the FDA closed a comment period on a proposal to reclassify pelvic mesh for pelvic organ prolapse as a Class-III, high-risk device. In a demonstration of the overwhelming support for the measure, the patient advocacy group We Are Mesh Survivors submitted hundreds of separate comments gathered in just three days from mesh-injured women and supporters urging the FDA to authorize the reclassification.
In April, a group of mesh survivors traveled to the JNJ Annual Shareholders Meeting to address CEO Alex Gorsky directly about their concerns.
“Mr. Gorsky, you hurt me,” said Teresa Sawyer of Toledo, Ohio, who has had four corrective surgeries to remove the mesh since it was implanted in 2011. “I started having massive infections and strange immune conditions.”
Morcellator, courtesy NYT
While Johnson & Johnson is not the only company manufacturing this product, it is the industry leader and has a reputation for ensuring that “mistakes are paid for,” as stated in its famous Credo. Johnson & Johnson should follow its own example: in the interest of ensuring the safe and effective use of its products, the company should withdraw pelvic mesh from the market before any more women are seriously injured.