Vaginal Mesh Effectiveness Target of New Boston Scientific Study
By: Austin Kirk | Published: June 10th, 2013 (FiDA highlight)
Boston Scientific announced last week that it is
working with the Pelvic Floor Disorders Network (PFDN) to study the effectiveness
of treating uterine prolapse with vaginal mesh compared to traditional surgery.
The company is contributing more than $1 million
to the study, which will look at one form of pelvic organ prolapse (POP) and
the available treatment options.
The announcement
comes two years after the FDA found that there was no evidence that
transvaginal mesh provides any additional benefits when compared to traditional
surgery, yet it appears to carry a risk of serious complications.
Concerns about the safety of surgical mesh for
treatment of pelvic organ prolapse and female stress urinary incontinence
gained widespread attention in July 2011, when the FDA indicated that nearly 3,000 reports of problems with
vaginal mesh were received by the agency between January 2008
and December 2010, including cases where the mesh eroded through the vagina,
caused infections and other debilitating injuries.
In early 2012, the FDA sent a letter to several
manufacturers of these products, ordering that they conduct additional studies and trials
to evaluate the safety of transvaginal mesh products, looking
for additional information to establish whether they pose an unreasonable risk
of injury for women.
Concerns Over Safety and
Effectiveness of Vaginal Mesh
The main
manufacturers of vaginal mesh products sold in the United States are Boston
Scientific, American Medical Systems (AMS), C.R. Bard, Johnson & Johnson’s
Ethicon and Gynecare subsidiaries, Coloplast Corp. and Cook Medical.
Many of
these products were approved through the FDA’s controversial 510(k) system,
which allowed the manufacturers to begin selling the devices without conducting
rigorous pre-market studies. Products were approved by the agency as long as
the manufacturer could indicate that it was “substantially equivalent” to other
products on the market.
As concerns have surfaced over the safety and
effectiveness of vaginal mesh, many of the manufacturers have elected to cease marketing
their products in an effort to avoid conducting the required
studies.
The new study announced last week by Boston
Scientific, the SUPeR clinical trial, is expected to enroll 180 women considering surgery
to treat uterine prolapse who do not plan to have any more children. The women
will either be implanted with the Boston Scientific Uphold LITE Vaginal Support
System or they will be treated with more traditional surgery, including a
vaginal hysterectomy.
The test
subjects will be evaluated every six months for up to five years. Researchers
will look at the safety, success, cost-effectiveness and other factors
resulting from the surgery. The final results are expected in 2018.
Vaginal Mesh Lawsuits
About
20,000 women throughout the U.S. are currently pursuing a vaginal mesh lawsuit against
the makers of these products, alleging that transvaginal surgical mesh is
unreasonably dangerous and defective, carrying a severe risk of painful and
debilitating health problems for women that outweighs any potential benefits.
The U.S. Judicial Panel on Multidistrict
Litigation (JPML) has established separate consolidated proceedings in the
federal court system for cases involving different manufacturers, with five
Multidistrict Litigations (MDLs) centralized before U.S. District Judge Joseph
Goodwin in the Southern
District of West Virginia.
According to an updated case
list (PDF) released on May 15, Judge Goodwin is currently
presiding over at least 2,938 Bard Avaulta lawsuits,
6,028 AMS vaginal mesh
lawsuits, 3,557 Boston
Scientific pelvic mesh lawsuits, 5,763 Ethicon Gynecare
mesh lawsuits and 320 Coloplast bladder slings
lawsuits.
Several cases pending in state courts throughout
the country have already gone to trial, with a California court awarding $5.5 million in damages to a
woman who experienced complications
with a Bard Avaulta mesh in July 2012, and a New Jersey
state court jury awarded $11.1
million in damages in February, including both compensatory and punitive
damages for problems with
Ethicon’s Gynecare Prolift mesh.
In the federal court system, the first vaginal
mesh trials are scheduled to begin next month, with a series of
lawsuits involving the Bard Avaulta mesh set to begin on July 6. Later this
year and early next year, a series of at least three additional trials will be
held involving AMS mesh, Boston Scientific mesh and Ethicon mesh.
These early trial dates are designed to help the
parties gauge how juries are likely to respond to certain evidence and
testimony that may be offered throughout the vaginal mesh litigation. The
preparation and any outcomes may help facilitate negotiations to reach vaginal mesh
settlements in other cases.
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