Here’s yet another example of how a product snuck through the system, and has caused so much damage in women that there now exist hundreds of medical product liability lawsuits aimed at its manufacturer.
Surgical mesh has been used in surgery for awhile. So when a new type of plastic mesh needed to be approved by the Food and Drug Administration, it apparently got fast-track approval, without the tests that the FDA typically requires for first-of-its-kind devices. The upshot? Johnson & Johnson, the manufacturer of the plastic surgical mesh, now plans to stop selling its surgical mesh implants that are used to treat women, because the mesh implants have been linked not only to injuries, but hundreds of lawsuits. So, this past Monday, J&J said that it plans to phase out four mesh products over the course of the next three to nine months.
The plastic mesh implants were used to strengthen a woman’s pelvic wall in cases of pelvic organ prolapse – a condition that happens when the bladder or other reproductive organs slip down into the vagina. Last year, it is estimated that about 75,000 women had received the mesh implants, although there is another type of surgery that can correct this problem, using a simple incision in the abdomen. Last year the FDA reported that these mesh implants were associated with higher rates of pain, bleeding, and infection than the traditional surgery that simply used stitches. One Miami woman, Lana Keeton, who had the plastic mesh implanted back in 2001, has undergone 17 – that’s correct – 17 surgeries to remove the implanted mesh. She even founded a group called Truth in Medicine, which has lobbied the FDA about the harmfulness of mesh. She has described the synthetic mesh as resembling “the cut edges of a window screen,” to show how harmful and sharp the mesh is, and to demonstrate how painful it makes sexual intercourse.
The FDA reported that at least 10% of women have experienced erosion of the mesh within one year of having the mesh implanted. More than half required follow-up surgery to remove the mesh, and some women required two or three surgeries.
As a Boston-Dedham product liability attorney, I am happy that these defective products are going to be removed from the marketplace. This is a victory for consumers, and it will be interesting to see the outcome of these product liability lawsuits.
Practicing for years as a Boston injury lawyer I can assure readers that the laws that govern the rights of people who have been injured due to defective products is very complicated. Dangerously product defects are more common than a lot of people realize, and can cause very serious consumer injuries, even death. These defects can originate in the design, manufacturing, distributing, advertising or even marketing of a product. Pharmaceutical and medical companies, like other industries, should be held legally accountable for their products, and several have been the target of class-action lawsuits. For example, witness the famous class-action lawsuit over Fen-Phen, the two diet drugs manufactured by American Home Products, later known as Wyeth, which were linked to heart disease. Wyeth, the manufacturer, now a part of Pfizer, was successfully sued for upwards of $14 billion – that’s billion.
In Massachusetts, manufacturers are legally obligated to make sure that their products are not harmful to consumers when they are used in the correct, instructed manner. Far too frequently, manufacturers overspend on advertising and marketing, and underspend their time and money, and do not ensure that their product will be safe for all consumers.