Power morcellators. Transvaginal mesh. Both are examples of the FDA’s faulty 510(k) process. I’ve written several times about transvaginal mesh – products that have caused tremendous personal injury to women in Alabama and throughout the United States. Last week, I sat through the deposition of our expert witness in one mesh case. This medical specialist has treated many women suffering from implanted mesh. He has seen first-hand the impact of these products. His testimony was a gripping account of the pain and suffering seen in so many patients.
Yet, the list of dangerous medical devices marketed through the 510(k) loophole is much longer than simply power morcellators and transvaginal mesh.
What is the 510(k) process and why is it a safety loophole for medical devices? In 2013, a Professor at the UCSF medical school explained “all you have to do is show that your device is substantially similar to a number of other devices.” But, here’s the real safety loophole. “And some of those devices which were originally approved have been recalled or pulled off the market, but their original approval was still allowed for those ‘predicate devices’ that claimed ‘substantial equivalence.’” In other words, a device may be approved although earlier versions have been pulled off the market due to patient safety risks. This is unacceptable.
A recent post in The Wall Street Journal sums up the issue related to power morcellators:
Regulator Didn’t Study Morcellator’s Cancer Risk Until 18 Years After Approving For Gynecology
Morcellators have been utilized in surgeries to remove uterine fibroids. The devices cut up larger tissue into smaller pieces that can be removed through smaller incisions. Sounds like a good idea – until researched and tested. About 1 in 350 women have cancerous tissue around these fibroids. Morcellators also cut up this cancerous tissue into many smaller pieces which can then migrate to other areas. This increases greatly the risk of cancer spread. The devices create a potentially fatal risk in patients.
On November 24, 2014, the FDA issued a new warning concerning power morcellators. This new FDA announcement begins:
Today, the U.S. Food and Drug Administration is taking immediate steps to help reduce the risk of spreading unsuspected cancer in women being treated for uterine fibroids. In an updated safety communication, originally issued in April 2014, the FDA warns against using laparoscopic power morcellators in the removal of the uterus (hysterectomy) or fibroids (myomectomy) in the vast majority of women.
The FDA announcement then discusses the new box warning added to morcellators. It informs medical providers:
Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.
Hopefully, this new warning will save lives. However, it is too little too late for many patients. These patients trusted that devices used on them had been studied and tested. They were misled by a system that too often rushes dangerous and defective products to the market. This loophole puts profit over safety. And, it is wrong.