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What are the side effects of poise Impressa?

5 min read

Affecting an estimated 1 in 3 women at some point in their lives, Stress Urinary Incontinence (SUI) is a common condition. While exploring solutions, it's crucial to ask: What are the side effects of Poise Impressa? [1.2.3]

Quick Summary

Poise Impressa is an over-the-counter vaginal device designed to manage stress urinary incontinence. Potential side effects range from mild, temporary discomfort and spotting to rare but serious infections.

Key Points

  • Not a Medication: Poise Impressa is a non-absorbent medical device, not a drug, that mechanically supports the urethra to prevent SUI leaks [1.6.1].

  • Common Side Effects: The most common side effects are typically mild and temporary, including discomfort, vaginal soreness, and minor spotting [1.4.2].

  • Infection Risk: Use of the device may increase the risk of developing urinary tract infections (UTIs) or vaginal infections [1.4.2].

  • Serious Risks: Rare but serious adverse events have been reported to the FDA, including sepsis and complications from unintended long-term retention of the device [1.4.3, 1.3.3].

  • Contraindications Exist: The product is not for everyone; it should not be used by those who are pregnant, under 21, or have certain vaginal or urinary conditions [1.5.2].

  • Specific Use: Impressa is designed only for Stress Urinary Incontinence (SUI) and is not effective for Urge Urinary Incontinence (UUI) [1.5.2].

  • TSS Risk Not Established: While TSS is a known risk for intravaginal products, a direct link between Impressa and TSS has not been established by the manufacturer [1.3.1].

In This Article

Understanding Poise Impressa and How It Works

Poise Impressa is not a medication or a pad; it is a non-absorbent, internal medical device available over-the-counter for the temporary management of Stress Urinary Incontinence (SUI) [1.4.2, 1.6.1]. SUI is bladder leakage that occurs during physical activities like coughing, sneezing, laughing, or exercising [1.6.2]. The device is inserted into the vagina much like a tampon and works by gently lifting and supporting the urethra, the tube through which urine passes [1.6.1, 1.6.2]. This added support helps to stop leaks before they happen [1.2.2].

Made with a flexible, soft core, Impressa is designed to fit comfortably and move with the body [1.2.2]. It is disposable and can be worn for up to 12 hours within a 24-hour period, though it should not be worn during menstruation [1.2.1, 1.5.5]. It is crucial to note that Impressa is only designed for SUI and is not intended for women who experience Urge Urinary Incontinence (a sudden, intense urge to urinate) or Mixed Incontinence [1.5.2].

Common and Temporary Side Effects

According to the manufacturer and clinical research, most side effects associated with Poise Impressa are mild and temporary, typically resolving within the first 14 days of use as the body adjusts [1.3.1, 1.4.2]. If these symptoms persist, it is recommended to stop using the product and consult a healthcare provider [1.3.1].

Potential mild side effects include:

  • Mild Discomfort: Some users may feel the device, especially initially. Proper insertion and finding the right size are key to comfort, and any discomfort should fade with use [1.3.1, 1.5.6].
  • Vaginal Soreness: Tenderness or soreness in the vaginal area can occur, particularly during the initial adjustment period [1.4.2].
  • Small Blood Spots: Finding small spots of blood on the device after removal can happen, especially in the first few weeks of use [1.4.2].
  • Increased Bladder Leakage: Paradoxically, some women may experience an increase in leakage. This could be a sign of improper fit or that the device is not suitable for their specific condition [1.4.2].

More Serious Potential Side Effects and User-Reported Issues

While the manufacturer highlights temporary issues, user reviews and FDA adverse event reports point to other potential concerns that can be more significant. It is important to consider these when evaluating the product.

  • Urinary Tract Infections (UTIs): The presence of a foreign device in the vaginal area can potentially increase the risk of developing a UTI [1.4.2]. Symptoms include a burning sensation during urination or a frequent urge to urinate [1.5.2].
  • Vaginal Infections: Similarly, the risk of vaginal infections (like yeast infections or bacterial vaginosis) may increase [1.4.2]. Symptoms can include itching, irritation, soreness, or a bad-smelling discharge [1.5.2].
  • Pain and Bleeding: Some users have reported significant pain that led them to stop using the product, as well as bleeding upon removal [1.3.6]. One doctor suggested that the device's rigid design could cause tearing in the sensitive vaginal tissue of post-menopausal women who may have less natural lubrication [1.3.6, 1.5.1].
  • Device Retention: The FDA's MAUDE (Manufacturer and User Facility Device Experience) database includes a report of a user who inadvertently retained the device for over a year, leading to infections and pain until it was discovered and removed by a doctor [1.3.3, 1.5.4].
  • Sepsis: In rare and severe cases reported to the FDA, use of the product has been associated with hospitalization for sepsis and septic shock, which are life-threatening conditions [1.4.3].

The Risk of Toxic Shock Syndrome (TSS)

Toxic Shock Syndrome (TSS) is a rare but very serious disease caused by toxins from bacteria [1.8.3]. The risk is known to be associated with products worn in the vagina, such as tampons and contraceptive diaphragms [1.8.1, 1.8.2]. While this risk exists for many intravaginal products, the manufacturer of Poise Impressa states that an association between their bladder supports and TSS has not been established [1.3.1].

Who Should Not Use Poise Impressa?

There are specific contraindications for this product. You should NOT use Poise Impressa if you [1.5.2]:

  • Are under the age of 21.
  • Are pregnant, might become pregnant, or have given birth within the last 3 months.
  • Have had unusual or unexpected vaginal bleeding in the last 6 months.
  • Currently have a urinary tract or vaginal infection.
  • Have had vaginal surgery within the past 3 months.
  • Have been diagnosed with a severely dry (atrophic) vagina.

It is also recommended to consult a doctor before use if you have pain during intercourse, difficulty retaining a tampon (which could indicate pelvic organ prolapse), or other underlying health concerns [1.5.2].

Comparison of SUI Management Options

Method Type How It Works Key Considerations
Poise Impressa Internal Support (Disposable) Lifts and supports the urethra from inside the vagina to prevent leaks [1.6.1]. Over-the-counter, must find the right size, can be worn up to 12 hours [1.2.1]. Potential side effects include discomfort, soreness, and risk of infection [1.4.2].
Pads & Liners External Absorption Absorb urine after a leak occurs [1.7.1]. Widely available, but can be bulky, cause skin irritation, and do not prevent leaks [1.6.2].
Reusable Pessaries Internal Support (Reusable) A silicone device inserted into the vagina to support pelvic organs and/or the urethra [1.5.3]. Another brand, Revive, is reusable for up to 30 wears [1.7.2]. Often requires fitting by a doctor [1.5.3]. Can be a long-term, cost-effective solution. Requires cleaning and maintenance.
Tampons Internal Absorption/Support While designed for menstruation, some studies and users note they can provide enough urethral support to reduce SUI leaks [1.7.4]. Not designed or FDA-cleared for SUI. Absorbent nature may lead to dryness or irritation if used for incontinence alone.
Pelvic Floor Exercises Physical Therapy Strengthens the pelvic floor muscles to provide natural support to the urethra and bladder. Non-invasive and can resolve the root cause. Requires consistency and proper technique, often guided by a physical therapist.
Surgery Surgical Intervention Procedures like a 'sling' are used to create permanent support for the urethra. Most invasive option, reserved for more severe cases. Carries surgical risks but can be a permanent solution.

Conclusion

Poise Impressa offers a unique, over-the-counter approach to managing Stress Urinary Incontinence by physically preventing leaks. For many, it can be a discreet and effective alternative to pads [1.2.1]. However, it is not a medication but a medical device with a specific mechanical function, and it is not without risks. While common side effects are often mild and temporary, users should be aware of the potential for more serious issues like infections, pain, and in very rare instances, life-threatening complications [1.4.2, 1.4.3]. Understanding the contraindications and consulting a healthcare provider, especially if you have pre-existing conditions or experience persistent side effects, is essential for safe use.


For more information from the manufacturer, you can visit the official product website: Poise® Impressa® Bladder Supports

Frequently Asked Questions

No, Poise Impressa is not a medication or a drug. It is an over-the-counter, non-absorbent medical device that is inserted into the vagina to physically support the urethra and prevent leaks [1.6.1].

According to clinical studies, the most common side effects are mild and temporary, usually lasting less than 14 days. They include small blood spots on the product, mild discomfort, and vaginal soreness [1.4.2].

Yes, developing a urinary tract infection (UTI) is listed as a potential side effect of using Poise Impressa [1.4.2]. If you experience pain or burning during urination, you should stop using the product and see a doctor.

You can wear a Poise Impressa bladder support for up to 12 hours in a 24-hour period [1.2.1]. It should be removed after 12 hours and should not be worn during your menstrual period [1.5.5].

Toxic Shock Syndrome (TSS) is a rare but serious condition associated with products worn in the vagina. However, the manufacturer states that an association between the use of Impressa Bladder Supports and TSS has not been established [1.3.1].

You should not use Impressa if you are under 21, pregnant or recently gave birth, have had recent vaginal surgery, have current vaginal or urinary infections, or have unexplained vaginal bleeding [1.5.2].

Using the wrong size may result in continued leakage or discomfort. The sizing kit is designed to help you find the best fit. If discomfort persists even after trying different sizes, you should stop using the product and consult your doctor [1.3.1].

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.