FDA Issues a Ban on Pelvic Mesh
There has been increasing concern over the use of surgical mesh in treating conditions such as hernias and other abdominal or pelvic issues. Numerous patients have reported adverse reactions, leading government officials to issue warnings concerning the safety of these products. Adverse effects can have lingering health impacts on patients and in some cases, have proven to be life threatening. As a result, there has been a surge in medical malpractice claims against surgical mesh manufacturers. Recently, the government took the dramatic step of issuing a ban against future sales.
Sale of Pelvic Mesh Prohibited
Surgical mesh is often used on both men and women to hold body organs and tissues in place. While proving helpful for some patients, others suffered serious complications from the implanted mesh, prompting warnings from the U.S. Food and Drug Administration in 2016. At the time, surgical mesh was manufactured by a number of providers, including nationally recognized companies such as Johnson & Johnson. After the FDA classified pelvic mesh in particular as being a ‘high risk’ medical device due to safety concerns, many of these companies either merged with other brands or stopped manufacturer pelvic mesh completely.
On April 16, 2019, the FDA took the dramatic action of prohibiting the two remaining manufacturers of pelvic mesh, Boston Scientific and Coloplast, from selling the product. The FDA states that there are reasonable concerns about patient safety which neither company has adequately addressed. With the announcement, the FDA gave both companies ten days to withdraw their product from the market.
Patients Who May Be Affected
One of the main concerns the FDA has with pelvic is its use in treating pelvic organ prolapse (POP), a common condition suffered by women. According to the U.S. Office on Women’s Health, POP occurs when the muscles and tissues supporting the uterus, bladder, rectum or other pelvic organs become loose or weakened. This can cause the organs to drop, creating bulges and discomfort in the pelvic region.
While lifestyle changes, good posture, and exercise can help address minor instances of POP, more serious conditions generally required transvaginal insertion of pelvic mesh for support. However, the mesh has been found to cause serious symptoms among patients, including:
- Chronic and severe pain;
- Vaginal bleeding or discharge;
- Fever and infections;
- Painful intercourse;
- Urinary or fecal incontinence;
- Loosening and bulging of the mesh, to the point that it may be visible outside the body.
The FDA warns women to check with their medical providers if they have had surgery involving pelvic mesh, especially if they are experiencing any of the above symptoms.
Reach Out to Us Today for Help
At the Law Firm of William E. Raikes, III, we help hold reckless and negligent medical device manufacturers accountable for the pain you suffer and for the medical expenses or lost wages you incur. If you are experiencing problems as the result of pelvic mesh or after other surgical procedures, reach out and contact our Fort Pierce medical malpractice attorney to request a consultation today.