Democratic lawmakers are calling for congressional hearings on
medical device safety in the United States, highlighting recent problems
with transvaginal mesh products and Lap-Band weight loss implants.
Congressman
Henry Waxman (D-CA) and other House Democrats have urged Republicans in
control of the House Energy and Commerce Committee to hold a hearing
over growing concerns that FDA approved medical devices are causing
individuals throughout the country to suffer debilitating and
potentially life-threatening complications.
The lawmakers want
congress to look into the activities of the manufacturers, seek records
regarding the safety record and design of the devices, and called for
hearings in a January 20
letter (PDF) to their Republican colleagues.
The
Lap-Band, or laparoscopic adjustable gastric banding, is a band placed
around the upper part of the stomach that creates a small pouch which
quickly fills with food. The band causes the person to feel full
quickly, which may result in weight loss. However, the Lap-Band is
linked to a number of complications, including erosion of the band
through the stomach wall, the band moving out of position, nausea,
vomiting, difficulty swallowing, gastroesophageal reflux disease (GERD),
abdominal pain, and leaking of the gastric band. In addition,
recipients must change their eating habits, as they are unable to eat
large meals and must eat a series of smaller meals throughout the day
for the rest of their lives or until they have the band removed.
Recent
studies found that 40% of patients who were implanted with Allergan’s
Lap-Band weight loss device suffered serious complications. In
addition, the FDA raised concerns in December that many clinics were
not fully disclosing the risks associated with Lap-Band procedures in advertisements.
Earlier this month, the FDA also
called for more studies into the safety of vaginal mesh products
used to treat pelvic organ prolapse (POP) and stress urinary
incontinence (SUI) in women, following growing reports of problems, and
the agency’s own analysis which brought into question whether they
provide any health benefits.
The Democrats point out that the
vaginal mesh products were approved through the FDA’s controversial
510(k) process, which only required that the devices be substantially
equivalent to products already on the market. That means they were not
required to provide extensive clinical studies before doctors began
inserting them into U.S. women.
The FDA is now requiring 99 new
postmarket studies, with 88 of those focused on surgical mesh for pelvic
organ prolapse and 11 targeting single-incision mini-slings used to
treat stress urinary incontinence. Manufacturers will have to submit
study plans to the FDA showing how the studies will address the agency’s
safety concerns.
An estimated 300,000 synthetic transvaginal meshes were implanted in women in the U.S. in 2010.
Last summer, the FDA issued a
warning about the risks of problems when vaginal mesh products are used,
especially for repair of pelvic organ prolapse. The federal health
regulatory agency indicated that it could find no benefit in using
transvaginal mesh to treat POP when compared to older, safer
alternatives.
Between 2008 and 2010, the FDA received more than
1,500 reports of transvaginal mesh complications, including erosion of
the mesh into the vagina, contraction or shrinkage of the mesh,
infections, pelvic pain, urinary problems, vaginal scarring and other
complications.
A growing number of
transvaginal mesh lawsuits
have been filed in courts across the country by women who say that
vaginal sling manufacturers created defective products and failed to
warn doctors or patients adequately about the risk of complications.
Democratic lawmakers sent a similar letter to Committee Chair Fred Upton and other Republicans on the committee in October to
ask for a hearing on brain stents and metal-on-metal hip implants, but Republicans have refused to respond.
I only hope that some how , some way , this helps at some point so many of us get our bands removed that need it !
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