Early last week (January 4, 2016), the FDA issued two final orders that reclassified mesh products designed and marketed for transvaginal treatment of pelvic organ prolapse (POP) as “High Risk Devices.” In addition, the FDA will require the manufacturers of these medical devices to undergo its difficult Premarket Approval (PMA) procedure. The PMA process will require manufacturers of transvaginally placed POP mesh to prove their products are both safe and effective for use in the public.
As such, the FDA classified transvaginal mesh products as class III high risk products, rather than their former class II moderate risk rating. This can been seen as a reaction to thousands of received reports of complication involving the use of mesh for transvaginal POP repair. The most common problems reported include severe pelvic pain, pain during intercourse, infection, bleeding, organ perforation and urinary problems from mesh eroding into surrounding tissues. After 100,000 lawsuits, the FDA has finally cracked down on transvaginal mesh .
Made of polypropylene plastic and originally developed to repair hernias, pharmaceutical companies now market pelvic mesh to women who experience an array of issues concerning their vaginal area. These women may experience SUI, involuntary urine leakage, and POP. Out of all the issues, pelvic organ prolapse is certainly the most disruptive in a woman’s life—if severe enough—whereby the organs are no longer supported by the tissue in the region and therefore the organs fall into and sometimes out of the vagina. The mesh was a fix to make the body strong enough to sustain these organs.
Pelvic Organ Prolapse
When pelvic organs bulge out of the body or cause such pain, it’s called prolapse. Medical studies have revealed that about half of women who deliver one or more babies through vaginal childbirth will experience prolapse. On that notion, after two vaginal births, a woman is eight times more at risk of prolapse than a woman who hasn’t given birth vaginally. In addition, after four vaginal births, a woman is 12 times more likely to suffer from prolapse. Babies who are heavier than 9 pounds during delivery are also causes for POP in women.
POP can also occur in women after going through menopause. This is due to the fact that their collagen levels are lower and this naturally occurring protein that helps the connective tissue repair itself after stretching or tearing is no longer effective. While prolapse isn’t always painful or in need of surgical repair, some women experience symptoms that range from uterus pressure to painful intercourse and all of the aforementioned problems already reported .
There is also a set of five stages that POP goes through called Pelvic Organ Prolapse Quantification system (POPQ). These stages start at stage 0, where the organs are in their normal position and end at stage IV, where organs protrude out of the body. When the organs start to protrude, the doctor will measure the length of extension. From there, the treatment will depend on how far the protrusion is at the time in question. If left untreated, organs will eventually bulge into the vagina or possibly hang out of the body when standing or walking.
The mesh is mostly made from synthetic material such as polyester or plastic or polypropylene. The term transvaginal refers to the type of technique used to implant the mesh through the vagina and into the area needed. It is thought to be quicker and less invasive. As such, manufacturers have come up with four separate groups of mesh products, formulated by the FDA, that are aimed in preventing POP or SUI. These categories include, non-absorbable synthetic, which is considered a permanent implant and is the most popular; absorbable synthetic mesh, which loses its strength over time and is not intended as a long-term treatment; biologic products are natural and derived from animal tissue that has be disinfected for implanting in the human body; and composite mesh, which is made from a combination of any of the aforementioned categories .
However, while the device was made to help women who suffer from these conditions, transvaginal mesh has become an unreliable product. Countless women who have had complications ranging from erosion and organ perforation to infections and urinary problems and have stories that when complied, make a massive horror story filled with individual accounts of obstacles. The physical and emotional harm from reoccurring surgeries and corrective measures can affect women’s work, relationships and daily activity. Intrinsically, there has been numerous lawsuits and massive payouts to women who pursued legal action against the pharma giants.
To address public concern, the FDA issued a statement in regarding their stronger requirements for device approval.
“These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse,” said William Maisel, M.D., M.P.H., deputy director of science and chief scientist for the FDA’s Center for Devices and Radiological Health. “We intend to continue monitoring how women with this device are faring months are years after surgery though continued postmarket surveillance measures.”
Continually, to warn doctors and patients about the use of surgical mesh for transvaginal POP repair, the FDA has:
- Issued safety communications in 2009 and in 2011 warning doctors and consumers about an increase in adverse event reports related to mesh used for urogynecological procedures;
- Convened an advisory panel in September of 2011 to solicit recommendations on actions to take regarding urogynecologic surgical mesh for transvaginal POP repair;
- Issued orders to manufacturers in January 2012 to conduct postmarket surveillance studies to address specific safety and effectiveness concerns related to surgical mesh sued for transvaginal repair POP; and
- Issue two proposed orders in Mary 2014 to reclassify the devices from class II to class III and to require manufacturers to submit a PMA application .
Dolman Law Group
While the FDA is finally putting their foot down on defective transvaginal devices, for some women, it’s too little too late. If you have suffered an injury or injuries due to the use of transvaginal mesh, you deserve full and fair compensation for your losses, including medical bills, lost income, pain and suffering, emotional trauma, and more.
Additionally, even with the FDA’s warnings, punitive damages may be available to deter companies from such negligent marketing and manufacturing. The experienced attorneys at the Dolman Law Group are here to offer free consultation to people who have suffered transvaginal mesh-related injuries. Additionally, we collect no fees unless you recover your losses. Please call us today at (727) 451-6900.
Dolman Law Group
800 North Belcher Road
Clearwater, FL 33765