When medical devices for women intended for better health outcomes prove to be fatal, it is disappointing. Recently, the FDA stopped all sales of surgical mesh devices that have been used for transvaginal repair of POP (pelvic organ prolapse).
POP is a condition where the tissues and muscles supporting the bladder, uterus, and rectum loosen or weaken, resulting in them pressing in or out of the vagina. The primary symptom of this is a vaginal bulge. However, it might lead to other conditions, like issues with bowel movements and urine leakage, which makes it challenging for a woman to lead a normal life.
According to the FDA, the manufacturers of vaginal mesh ensured effectiveness and safety based on the agency’s deadline. However, several women noticed various complications that led to rising lawsuits against the manufacturers. It also resulted in a settlement of close to $8 billion for 100,000 women who faced infections, inflammation, pain, and bleeding due to this device.
In this article, we will shed light on the issues linked with the vaginal mesh device, what made the FDA halt sales, and alternatives that women can resort to.
Why Did FDA Stop Sales of Vaginal Mesh?
The FDA didn’t impose any restrictions on mesh usage when prolapse surgery is conducted through one’s abdomen. It doesn’t impact the transvaginal mesh used for treating SUI (stress urinary incontinence), which is known as a sling procedure. It is a urine leakage that takes place when a woman exercises, sneezes, coughs, or lifts any heavy object.
The condition affects one out of every three women on average and results from a weak bladder sphincter muscle, sometimes because of aging and childbirth. Here, the urologists and obstetrician-gynecologists at Yale Medicine state that they worry women might incorrectly think that FDA sanction includes all pelvic floor surgeries, including mesh use.
According to Leslie M. Rickey, a reconstructive and female pelvic medicine surgeon, women are confusing the use of transvaginal mesh for prolapse with mesh slings used for treating laparoscopic procedures and stress incontinence for POP.
Now that this process is off the table, women might think about what can be used instead of mesh for prolapse. Here, Leslie asserts that there are various other treatment options and safe alternatives that women should search and opt for to stay away from physical hazards.
Health Hazards of Vaginal Mesh and Alternative Treatment Options
Even if not for the reason mentioned by the FDA, there are other factors that make the vaginal mesh risky. Women often face infections after mesh surgery. It can either be a standalone complication or result in damage to the pelvic organs and pain at the time of intercourse.
TruLaw states that mesh erosion is a common issue that most women complain of. It results in adverse symptoms like unusual discharge, bowel and bladder issues, irregular bleeding, and pain. In certain situations, there is a need for added treatment to correct this side effect, which can lead to emotional trauma.
Hence, it’s a wise decision for women to speak with their gynecologist and use other treatments to remedy vaginal prolapse. Some of the useful ones include:
Kegel’s Exercise
It is an effective treatment, and you need to talk to your GP about this before starting the exercise. Here, one needs to pull their pelvic floor for about three seconds and then relax. It is recommended that women do a minimum of 24 contractions per day for six weeks to witness visible results.
Vaginal Cone
It is a medical device that has been designed in the form of a tampon with a string attached to it. It ensures that the pelvic floor muscles are engaged so that the cone doesn’t fall out. As a result, it strengthens vaginal walls.
Native Tissue Repair
Here, the body’s tissues get used instead of a synthetic mesh for repairing loose vaginal walls.
Estrogen Creams
Medical experts believe that topical estrogen creams can improve SUI in women. Hence, estrogen in the form of an insert or cream can help to firm the vaginal walls.
Vaginal Ring
This ensures that the vaginal wall is in the right place. Vaginal ring pessaries can be looked upon as an option when vaginal prolapse is severe. However, it is necessary to not opt for surgery. Furthermore, the ring should be replaced after four months.
Lifestyle Changes
It can range from weight management to dietary changes, and not lifting heavy objects, which will ultimately help to strengthen a woman’s pelvic floor muscles.
Summing up, women must get their routine medical check-ups and pelvic examinations annually. When diagnosed with POP, it is recommended that women don’t readily opt for a vaginal mesh implant without confirming if that is the only treatment they require. It is necessary to ask about alternative treatments from the healthcare provider and follow them diligently to notice visible differences.
The alternative treatment options for vaginal mesh surgery discussed above can be of help to many women. Women should consult their gynecologists and select the ones that seem beneficial to them.
