Mesh News Desk, October 14, 2015 ~ As trial lawyers gather in Las Vegas for the twice-yearly Mass Torts Made Perfect, hosted by Levin Papantonio Law, one cannot help but notice the agenda for the last day – areas ahead for future litigation or areas that are waning.
As you might have guessed, transvaginal mesh is on the list.
Know that active litigation has been ongoing for close to four years so one can only imagine that it is in the “wrapping up” category. Attorney Henry Garrard (Blasingame Burch) will be addressing the topic.
Good to see that other areas are being addressed such as the power morcellator, another experimental medical device that was cleared for use on women by the U.S. Food and Drug Administration (FDA) under its 510(k) fast-track clearance program.
Last year the FDA warned doctors against using the power morcellator because it can spread hidden cancers hiding in the uterus. The morcellator grinds up a uterus during hysterectomy making it easier to remove.
The power morcellator was approved beginning in 1991. Johnson & Johnson makes one brand. Although it has not been recalled and doctors are warned about its use, power morcellator remains a tool some doctors still insist should remain in their “toolbox.”
BACKGROUND: See the Wall Street Journal article:
The WSJ reports over the last 20 years, the FDA cleared at least 10 such power morcellator made by various companies.
The 510(k) process was created by Congress in 1976 and today at least 90% of medical devices are “cleared” for marketing under the provision. There are roughly 3,000 new medical devices that enter the U.S. market every year.
In contrast, under the FDA, new drugs must undergo clinical trials and PMA or premarket approval to prove safety and efficacy. According to the WSJ, there are about 30 new drugs approved for the U.S. market annually. #