Monthly Archives: July 2011

FDA Issues Warning About Vaginal Mesh

The Food and Drug Administration has issued a warning to surgeons and prospective female patients about a vaginal mesh that’s been used in surgeries to correct a condition known as pelvic organ prolapse. The directive called on surgeons to consider other options to the mesh until the FDA can convene an advisory committee to explore more thoroughly the problems with the vaginal mesh.
Use of the mesh is widespread with approximately 100,000 women having the mesh surgery each year. According to the FDA, mesh-related symptoms include painful sexual intercourse, infections, urinary problems, overall discomfort, and bleeding, usually from the mesh eroding through the stitched tissue or from skin contracting tightly around it.
According to the Boston Globe, “In 2008, the FDA announced that “rare’’ problems could be associated with transvaginal placement of the mesh, which is used along with surgical stitches to support sagging pelvic organs such as the bladder, uterus, and bowel after they have been lifted back out of the vagina, where they descended.
From 2008 to 2010, the FDA received 1,503 adverse event reports associated with mesh used for pelvic organ prolapse repair, five times as many as the agency received from 2005 to 2007. It also received three reports of deaths that were related to the mesh placement procedure.
Recent studies indicate that about 10 percent of women who have the mesh placed transvaginally experience mesh erosion within 12 months of surgery and that more than half require additional surgeries to remove the mesh. Less commonly, the mesh becomes so intertwined with scar tissue that it cannot be removed.”

DePuy Hip Lawsuits Intensifying

As more DePuy ASR XL lawsuits are filed, both sides are gearing up for a complicated litigation process. Johnson & Johnson, the parent company of DePuy Orthopaedics, has already submitted 200,000 pages of documents regarding the failed DePuy ASR XL hip replacements, according to the Wall St. Journal. In the end, the medical device company is expected to have to submit 18,000,000 pages of documents. Thousands of hip lawsuits have already been filed with most being consolidated in the multidistrict litigation in northern Ohio.
Johnson & Johnson has told the Wall St. Journal that it has already fielded 27,000 calls from DePuy hip sufferers who’ve needed assistance with reimbursements or information about the recalled hip. The company estimates that there are approximately 37,000 DePuy hip patients in the United States and 93, 000 worldwide. Some of these patients have already undergone the expensive, complicated, and painful hip revision surgery in order to have the failed DePuy hip replaced.

3 Doctors Cited for Not Disclosing Pay

Harvard Medical School and Massachusetts General Hospital have punished three psychiatrists for failing to disclose payments they received from companies in their industry. The three doctors, Joseph Biederman, Thomas Spencer, and Timothy Wilens received $4.2 million from drug companies for psychiatric research performed between 2002 and 2007. The income was never reported to either medical institution or the federal government.
It’s hard to fathom why doctors would continue to hide payments in such conflict of interest cases especially when the federal government has demonstrated a heightened concern over the issue as well as a willingness to investigate such matters.
The three doctors will be prohibited from receiving any payments for such research for one year as well as undergo conflict of interest training. In light of the potential harm such conflicts can generate, the penalty seems to be no more than a light slap on the wrist especially given some of the research they were doing.
According to National Public Radio, “The accusation carried more weight because Biederman is a leading proponent of the off-label use of antipsychotic drugs to treat bipolar illness in children. His work is widely seen as contributing to an explosive growth in such prescriptions, and much of his support came from companies that benefited from his research.
Biederman and the other two psychiatrists have also published extensively on the treatment of attention deficit hyperactivity disorder.”