The present batch of vaginal mesh implants had been cleared for sale and distribution by the Food and Drug Administration (FDA) through its 510(k) pre-notification process, reports Bloomberg. Under this provision, a medical device may be cleared for distribution as long as it is “substantially equivalent” to a predicate product.

The predicate product in this case, based on the same report, is the ProteGen Sling manufactured by Boston Scientific. Originally intended for the treatment of stress urinary incontinence (SUI), it was never in the market for long since this was recalled in 1999 due to its high failure rate. The FDA even labeled this product as “misbranded” and “adulterated,” according to a report by the New Jersey Star-Ledger in 2002.

What many may find very puzzling is why these new vaginal mesh devices were even cleared in 2004 when the product it was supposed to be substantially equivalent was recalled five years earlier due to it high complication rates. This decision would certainly raise a lot of questions. Were they motivated by other factors? Whatever it is, the fact remains that because of this decision, millions of women will continue to suffer and may live the rest of their lives in misery.

Reference:
commonhealth.wbur.org/2011/11/surgery-under-scrutiny-what-went-wrong-with-vaginal-mesh

Metal-on-metal hip implants might cause tissue damage which may sooner or later induce pain and the need for revision operations, according to a U.S. watchdog. This prompted many orthopedic companies to voluntarily recall some of its products. One of them is Stryker Rejuvenate hip recall.

The hip implant’s ball and socket do actually rub against each other, for instance, while running or walking, resulting to metal ions being released, that may impair the tissue adjacent to the implant.

Patients should be aware of the advantages as well as the disadvantages of metal-on-metal hip implants, including that the implant may need to be changed, sometimes sooner than as expected.

The FDA, on its newly released advisory article, urged all patients with the metal-on-metal hip implant to undergo medical exams, with or without experiencing symptoms of the said device such as inflammation, loosening of implant, pain, dislocation, and of course, metallosis.

Health experts in the U.S., Canada, and the UK have cautioned that full metal-on-metal hip implants have higher failure rate and with adverse reactions which include tissue damage near the joint compared with the metal-and-plastic type of implants.

In U.K. and other countries, records show that metal-on-metal implants are possibly more to depreciate, causing patients to have higher levels of cobalt, chromium and other metals in their body.

Sources:
fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241604.htm
medicalnewstoday.com/articles/255083.php