Boston Scientific Corp. (NYSE:BSX) and Varian Medical Systems Inc. (NYSE:VAR) posted recalls this month, with one company’s reports being noteworthy for timing along a growing issue in women’s health and one for frequency.
Boston Scientific’s surgical mesh recall caught attention for its coming up during ongoing FDA concerns about the side-effects of the transvaginal mesh devices in relation to their low clinical benefit.
Varian’s recalls were interesting for their sheer quantity – 15 Class II recalls this month across seven products.
Boston Scientific issued a Class II recall of its Pinnacle pelvic floor repair kit early this month over the potential for the needle to detach from the mesh during placement. Although unrelated to side-effects of transvaginal mesh use, the recall comes amid FDA concerns and public group demands that the devices be recalled over an warnings that the device may expose patients to unnecessary risk without offering clinical benefit above safer options.
The product is used to treat pelvic organ prolapse, which occurs when internal organ support structures become so weak or stretched that organs, like the uterus, bladder or bowels, sag from their normal position and bulge or prolapse into the vagina.
This week consumer advocacy group Public Citizen, founded by Ralph Nader, filed a petition to the FDA today asking the watchdog agency to ban the marketing of all currently available non-absorbable surgical mesh
products indicated specifically for transvaginal repair, order all manufacturers to recall the products and require all future transvaginal mesh devices to be classified as Class III devices and submitted as premarket approval applications.
Varian’s recalls are numerous and varied, including probes, X-ray collimeters and linear accelerators. One recall covers the company’s Clinac, Trilogy, Trilogy Tx and Novalis Tx linear accelerators, used in radiosurgery and precision radiotherapy for lesions, tumors and other conditions where radiation treatment is used.
"On Varian Linear Accelerators where the customer may calibrate the collimator angle position readout in reverse, switching the 90 degree and 270 degree positions," according to the report.
Other reports include GammaMed plastic needles with tips that may detach in a patient upon withdrawal, Eclipse radiotherapy treatment planning systems with a software bug that could shift the treatment field energy suddenly and Multileaf X-ray collimeters that may deliver the wrong radiation dose.