Monday August 20, 2018

“Vaginal Rejuvenation” is Dangerous, Says The FDA

Women considering treatment for vaginal symptoms should speak to their doctor about the potential and known benefits and risks of all available treatment options

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The procedures use lasers and other energy-based devices to destroy or reshape vaginal tissue. Pixabay
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The US Food and Drug Administration (FDA) has slammed all those devices being marketed for medical procedures like vaginal rejuvenation as “egregious” and causing “harm”, a statement said.

The regulatory body has found that a growing number of manufacturers were marketing such devices to women, claiming to treat conditions and symptoms related to menopause, urinary incontinence or sexual malfunction.

The procedures use lasers and other energy-based devices to destroy or reshape vaginal tissue.

However, “these products have serious risks and don’t have adequate evidence to support their use for these purposes. We are deeply concerned women are being harmed”, said FDA Commissioner Scott Gottlieb.

The FDA found that the use of these devices caused numerous cases of vaginal burns, scarring, pain during sexual intercourse and recurring or chronic pain.

Countering an earlier clearance on laser and energy-based devices for treating serious conditions, including pre-cancerous cervical or vaginal tissue, as well as condylomas (genital warts), the FDA said at that time its safety and effectiveness had not been evaluated or confirmed for vaginal rejuvenation, the statement said.

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The FDA found that the use of these devices caused numerous cases of vaginal burns, scarring, pain during sexual intercourse and recurring or chronic pain. Pixabay

Moreover, these devices are also being marketed to women who have completed treatment for breast cancer and are experiencing symptoms caused by early menopause, the regulatory body found.

“The deceptive marketing of a dangerous procedure with no proven benefit, including to women who’ve been treated for cancer, is egregious,” Gottlieb said.

“Today, we’re warning women and their healthcare providers that the FDA has serious concerns about the use of these devices to treat gynecological conditions beyond those for which the devices have been approved or cleared,” Gottlieb said.

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The deceptive marketing of unproven treatments may not only cause injuries but may also keep some patients from accessing appropriate, recognized therapies to treat severe medical conditions.

“Women considering treatment for vaginal symptoms should speak to their doctor about the potential and known benefits and risks of all available treatment options,” Gottlieb noted. (IANS)

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FDA Approves the New Generic EpiPen

Teva’s generic shot will be the first version that pharmacists can substitute even when doctors prescribe the original EpiPen

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A pharmacist holds a package of EpiPens epinephrine auto-injector, a Mylan product, in Sacramento, Calif., July 8, 2016. Mylan has a generic version of its emergency allergy treatment and a new competitor has been given FDA approval. (VOA)

U.S. health officials Thursday approved a new generic version of EpiPen, the emergency allergy medication that triggered a public backlash because of its rising price tag.

The new version from Teva Pharmaceuticals is the first that will be interchangeable with the original penlike injector sold by Mylan. The Food and Drug Administration announced the approval in a statement.

EpiPen injections are stocked by schools and parents nationwide to treat children with severe allergies. They are used in emergencies to stop potentially fatal allergic reactions to insect bites and stings and foods like nuts and eggs.

EpiPen maker Mylan has dominated the $1 billion market for the shots for two decades. Several other companies sell competing shots containing the drug epinephrine, but they aren’t heavily marketed or prescribed by doctors.

In 2016, Congress blasted Mylan in letters and hearings for raising EpiPen’s to $600 for a two-pack, a five-fold increase over nearly a decade. The company responded by launching its own lower-cost generic version for $300.

Mylan CEO
Mylan CEO Heather Bresch testifies, Sept. 16, 2016, before Congress over the cost of her company’s EpiPens. Lawmakers are outraged at high prescription drug costs, without acknowledging the role Congress may have played. (VOA)

Mylan continues to sell both versions at those prices, according to data from Elsevier’s Gold Standard Drug Database.

Teva’s generic shot will be the first version that pharmacists can substitute even when doctors prescribe the original EpiPen.

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A Teva spokeswoman declined to comment on the drug’s price but said it would launch “in the coming months.” Generic drugs can be priced as much as 80 percent lower than the original product. But those price cuts usually appear after several companies have launched competing versions.

Teva’s bid to sell a generic EpiPen faced multiple setbacks at the FDA, which rejected the company’s initial application in 2016. While epinephrine is a decades-old generic drug, Teva and other would-be competitors struggled to replicate the EpiPen’s auto-injector device. (VOA)