The Food and Drug Administration has ordered a ban on the sale and distribution of pelvic mesh products following claims of injuries inflicted to women.
Doctors use surgical mesh to help women suffering from incontinence and a condition known as pelvic organ prolapse or POP. However, several reports have surfaced regarding patients developing side effects such as severe discomfort, permanent incontinence, and an inability to engage in sex.
The states of California, Kentucky, Mississippi, and Washington have filed lawsuits against manufacturers on behalf of victims of pelvic mesh complications. They claim that makers did not fully disclose the health risks associated with their products.
This led to the FDA putting a hold on the marketing of surgical mesh.
"In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP," the agency said.
"That evidence was lacking in these premarket applications, and we couldn't assure women that these devices were safe and effective long term."
What Is Pelvic Organ Prolapse?
Pelvic floor disorders continue to be a major concern for many women. In fact, one in every five develops conditions such as fecal incontinence, urinary incontinence, and pelvic organ prolapse, according to Women's Health.
Patients who develop POP experience a weakening of the muscles and ligaments supporting their pelvic organs. This causes the organs to drop lower in their pelvis, resulting in a bulge in their vagina (prolapse).
The condition commonly occurs in women years after they have given birth. It can also happen following a hysterectomy or after patients enter their menopause stage.
While POP develops less frequently compared to urinary or fecal incontinence, the condition does affect as much as three percent of American women.
Older women have been shown to be more susceptible to POP compared to younger women. It is also more common among whites and Hispanics than members of other race or ethnic groups.
There are also instances where women develop more than one disorder, such as urinary incontinence with POP.
Several treatments are available to address pelvic organ prolapse. Patients are recommended a particular procedure, depending on the type of POP they have, their symptoms, their age, and other health issues. Doctors also factor in whether the patient is sexually active.
POP sufferers may undergo the following procedures:
Pessary Insertion
Pelvic floor muscle therapy
Changing eating habits
Colpocleisis (surgery to close the vagina)
Surgery to support the uterus or vagina
For sexually active women, doctors recommend undergoing surgery to address pelvic organ prolapse. The procedure sometimes involves using the patient's own body tissue or a surgical mesh to repair POP. The FDA has enforced strict safety guidelines regarding the use of such devices.
Issues With Pelvic Mesh Products
Some POP patients who received pelvic mesh surgery reported of developing complications, such as pain in pelvis or groin, pain during sex, and persistent vaginal bleeding or discharge.
Several consumer protection groups, including Public Citizen, called for a ban against the use of such devices as early as 2011. They believe pelvic mesh products are only injuring many women.
Dr. Michael Carome, director of Public Citizen's Health Research Group, welcomed the FDA's decision to stop the sale and distribution of surgical mesh.
However, he said the move may have come too late for the thousands of POP sufferers, who were left with irreparable damages because of the devices.
In its ban announcement, the FDA said pelvic mesh makers Coloplast and Boston Scientific failed to provide a reasonable assurance that their products are safe and effective to use.
