FDA Bans Sales of Surgical Pelvic Mesh
May 9, 2019
Over the past several years, the safety of surgical mesh devices has sparked widespread controversy and more than 100,000 lawsuits. Manufacturers have paid out close to $8 billion to women asserting they were seriously harmed by pelvic mesh products in particular. Last month, the FDA banned two surgical mesh companies, Boston Scientific and Coloplast, from selling their products in the U.S.
The FDA ordered the two companies to stop sales and distribution of surgical pelvic mesh products used to treat pelvic organ prolapse (POP). This is one of the strictest steps the FDA has taken to date regarding the use of these widely-disputed devices.
The FDA ban does not apply to transvaginal mesh devices used to treat stress urinary incontinence (SUI).
What is Pelvic Organ Prolapse (POP)?
Women may develop pelvic organ prolapse (POP) after pregnancy, childbirth, a hysterectomy, menopause or as a result of age. As the supporting muscles and ligaments weaken, the pelvic organs drop from their normal position (prolapse).
When this happens, women may feel pressure in the pelvic area or experience other symptoms. The bladder is the organ most commonly affected by pelvic organ prolapse.
What is Surgical Mesh?
Doctors use surgical mesh, a screen-like material, to repair weakened or damaged tissue associated with pelvic organ prolapse. The surgical mesh is implanted in the vaginal wall to provide support.
These devices are made from non-absorbable or absorbable synthetic polymers, animal tissue or a composite. Non-absorbable synthetic polypropylene devices are the kind most commonly used in pelvic reconstructive surgery.
Surgical mesh is also used to treat other conditions such as stress urinary incontinence (SUI). However, statistics show women who were treated for pelvic organ prolapse have a much higher incidence of severe complications.
When physicians began using surgical mesh in the 1990s, it was considered a moderate-risk product. Over time, FDA officials became increasingly worried as more and more women reported experiencing serious complications.
Some manufacturers, including Johnson & Johnson, voluntarily took their mesh products off the market as a result of the rising number of lawsuits and patient complaints.
In 2016, the FDA reclassified surgical mesh as high-risk, a classification requiring manufacturers to apply for “premarket approval.” This meant manufacturers had to provide documentation supporting the safety and benefits of surgical mesh for patients with POP. The FDA asked the companies to establish that surgical mesh was a better option than surgical tissue repair without pelvic mesh. FDA officials ordered the recent ban after concluding the manufacturers’ premarket applications failed to prove their products were safe and beneficial.
Complications Associated With Surgical Mesh
Thousands of women have suffered serious complications from surgical pelvic mesh implants. Often, these women continue to experience symptoms even after undergoing surgery to have the devices removed. In addition, many women suffer from lifelong and irreversible damage, including chronic pain and sexual dysfunction. Approximately 80 women have died from untreatable infections and other conditions resulting from surgical mesh devices.
Here are some of the most common complications:
- Organ perforation
- Urinary problems such as incontinence or difficulty urinating
- Persistent bleeding
- Chronic pain
- Impaired sexual ability
- Vaginal mesh erosion or contraction, resulting in pain and/or additional surgery
- Recurring pelvic organ prolapse after surgery
- Lupus-type symptoms such as muscle pain, confusion and lethargy
- Depression and other mental health issues
If you or a loved one has suffered harm from a surgical pelvic mesh implant, or any other medical device, contact us immediately. Our experienced and compassionate lawyers will help you receive the compensation you and your family deserve.
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