A Medical Device Daily
The FDA late last week reported that it will hold a public meeting in the fall to gather information about current developments in uses of nanotechnology materials in FDA-regulated products. In a Federal Register notice displayed today announcing the meeting, FDA asks that those interested in presenting at or attending the meeting inform the agency of their interest.
Nanotechnology is described by the National Nanotechnology Initiative (Washington) as the understanding and control of matter at dimensions of roughly one to 100 nanometers, where unique phenomena enable novel applications. Essentially, nanotechnology is a branch of science devoted to the design and production of extremely small matter.
Due to the small size and special properties of nanotechnology materials, they have great potential for use in a vast array of FDA-regulated products. These small materials often have physical or chemical properties that are different than those of their larger counterparts. These differences include altered magnetic properties, altered electrical or optical activity, increased structural integrity, and enhanced chemical and biological properties.
These differences have the potential to lead to scientific advances. For example, this technology could be used to create new drug formulations and routes of delivery to previously inaccessible sites in the body.
The FDA said the meeting will hear about:
• new types of nanotechnology products under development in the areas of foods and dietary supplements, food and color additives, animal feeds, cosmetics, human and animal drugs and human biologics and medical devices;
• specific scientific issues related to the development of these products relevant to FDA's regulation of them;
• other issues about which regulated industry, academia and the interested public may wish to inform FDA concerning the use of nanotechnology in FDA-regulated products;
• and any opportunities for the agency to address hurdles that may be inhibiting the use of nanotechnology in medical product development.
The agency said it is not accepting registration at this time but "would appreciate" expressions of interest from those intending to attend or present at the meeting to help in meeting preparation and planning. Information can be provided to Poppy Kendall at Poppy.Kendall@fda.hhs.gov, or 301-827-3360. Details about the venue, specific date, time, and registration will be provided in a Federal Register notice closer to the meeting.
Pelvic organ prolapse reduction via 2 surgeries
By performing two surgical procedures during the same operation, researchers in a National Institutes of Health (NIH) network reported reducing by half the incidence of urinary incontinence in women with a condition known as pelvic organ prolapse. Ordinarily, a single surgery is performed to correct pelvic organ prolapse, and a second surgery is performed only if incontinence develops.
"This is an important advance in treatment for a large number of women," said Duane Alexander, MD, director of NIH's National Institute of Child Health and Human Development (NICHD). "More than 200,000 women have prolapse surgery every year, and these research findings could prevent incontinence in many of them."
These findings, reported by NICHD's Pelvic Floor Disorders Research Network, appear in the April 13 issue of the New England Journal of Medicine.
Pelvic organ prolapse occurs when the pelvic muscles and connective tissue within the pelvic cavity weaken or are injured, said Anne Weber, MD, of the Institute's Contraception and Reproductive Health Branch, NICHD author and program officer of the study. The tissue ordinarily supports the vagina and holds it in place within the pelvis. Without normal support, however, the uterus, bladder, and bowel press down on the vagina, causing it to invert and, in some women, these organs eventually protrude through the vaginal opening.
With advanced pelvic organ prolapse, the vaginal protrusion may cause a kinking of the urethra, blocking the flow of urine and preventing the bladder from emptying completely (called partial retention). This retention, in turn, may lead to frequent or persistent urinary tract infections. In other cases, depending on the individual, pelvic organ prolapse may occur along with stress incontinence - urine leakage from the bladder during a cough or a sneeze.
To treat pelvic organ prolapse, gynecologists may recommend that patients have a surgical procedure known as sacrocolpopexy, Weber said. In this procedure, surgical mesh and sutures are used to anchor the vagina to the sacrum.
However, after sacrocolpopexy, many women experience incontinence, which makes them candidates for a second surgical procedure, the Burch colposuspension. With Burch colposuspension, Weber said, additional sutures are sewn through the wall of the vagina and anchored to ligaments inside the pelvic cavity, near the pubic bone.
The Network investigators undertook the current study to determine if proactively performing the Burch colposuspension at the same time as sacrocolpopexy might prove effective at preventing incontinence in women with prolapse who did not have symptoms of stress incontinence before surgery.
For their study, the researchers randomly assigned women who were undergoing sacrocolpopexy to receive either Burch colposuspension or no additional surgery. Of 322 women, 157 received Burch colposuspension and sacrocolpopexy, and 165 received only sacrocolpopexy.
Three months after their surgery, the women were evaluated according to standardized criteria for urinary stress incontinence. These criteria measured incontinence that occurred in response to such activities as coughing, sneezing, laughing, physical exercise, lifting, or bending over. Of the Burch group, 23.8% met one or more criteria for stress incontinence. In comparison, of the group that underwent sacrocolpopexy alone, 44.1% met one or more criteria for stress incontinence.
Three months after the surgery, 24.5% in the control group reported bothersome symptoms of incontinence, compared to 6.1% of women in the Burch colposuspension group.
"In women without stress incontinence who are undergoing abdominal sacrocolpopexy for prolapse, Burch colposuspension significantly reduced postoperative symptoms of stress incontinence without increasing other urinary tract symptoms," study authors wrote.
In addition to the NICHD, other member institutions of the Pelvic Floor Disorders Research Network that participated in this study were the Loyola University Medical Center (Maywood, Illinois); the Johns Hopkins University (Baltimore); Baylor College of Medicine (Houston); the University of Iowa (Iowa City); the University of Alabama at Birmingham ; the University of North Carolina (Chapel Hill); the University of Pittsburgh ; and the University of Michigan (Ann Arbor).