Ethicon, a Johnson & Johnson subsidiary, might be a company much better known for controversy than the “history of advancing surgery” it claims to sustain. But as the biggest manufacturer of some of the medical industry’s most prominent products and brands, Ethicon would do well to keep its word.
It seems, however, that 1 product has done enough damage to ruin any positive reputation Ethicon might hope to build: Physiomesh™ Flexible Composite Mesh. The problems this product has caused are not only life-altering but far-reaching, affecting thousands of consumers in major pharmaceutical markets worldwide.
Physiomesh Danger Knows No Bounds
In the United Kingdom, for example, where 1 in 10 people will develop a hernia in their lifetime, the National Health Service (NHS) has been recommending surgical mesh treatment on tens of thousands of patients every year for decades. After 800 of these patients sued the NHS and Johnson & Johnson over the use of J&J’s vaginal mesh implants – which has cost the company $120 Million so far – concerns grew about the company’s other hernia mesh devices.
One woman, who underwent an umbilical hernia mesh repair in 2013, was rushed to hospital 2 years later for revision surgery after “agonizing” pain left her “screaming on all fours.” Experts are concerned about similar cases, citing “thousands of hernia mesh patients who are living with chronic pain.”
But this is only in the United Kingdom. In Canada, where Physiomesh was recalled in June 2016 after use by an estimated 30,000 Canadians, class action lawsuits are finding Ethicon accountable for alleged perforations, infections, hernia mesh pain, and 3 deaths. In the states, similar cases are mounting; the latest in Texas, where a couple filed a hernia mesh lawsuit after difficult revision surgery.
Injured and Maimed
On numerous occasions, the device has been associated with side effects such as bowel obstruction, nerve damage, improper would healing, and excessive inflammation, as well as chronic pain and mesh migration.
These are ironically the very side effects hernia mesh is designed to avoid. The implant procedure involves “patching” over weakened or town muscles or tissue with multiple layers of netting material. This multi-layer structure promises to be more effective in preventing inflammation and facilitating the mesh’s seamless integration with the body.
Plaintiffs argue that, instead, Ethicon has created an unsafe, ineffective product that causes far worse health concerns than hernias themselves – and worse, the company has failed to provide warnings of these risks.
Isn’t This Obvious to the FDA?
As it always has, Ethicon continues to deny any deliberate secrecy and to support the safety of its products. In a 2016 voluntary recall notice, the company even tried to blame complications on doctors and patient conditions.
However, tens of thousands of lawsuits are queueing up to tell the same story of pain and distress with clear evidence to the contrary: that fault lies solely with the product. So how can Physiomesh still be a readily available treatment option?
Indeed, the NHS is now rolling out a mesh-free alternative for the U.K. called the Shouldice hernia repair, a technique developed at the Shouldice Hernia Center in Toronto. Canada has already withdrawn the product from its market. But in the U.S.? While the Food and Drug Administration (FDA) has acknowledged adverse hernia repair events, the agency is notorious for approving Ethicon’s products without adequate testing and is slow to respond to urgent patient needs. Physiomesh, therefore, remains as marketable as ever.
For the moment, multimillion-dollar lawsuits against Ethicon continue. It’s been a long journey since the product was first introduced in 2010, and for many, the greatest remaining hope is that this journey comes to an end sooner rather than later.