The process of regulating medical devices seems to be a tricky balance to get right. The FDA is under a lot of pressure from industry lobbyists to ease up on its requirements, and it is true that it is far more stringent than the regime in Europe.
That said, Johnson & Johnson’s decision to stop selling its power morcellators – devices used to break up uterine fibroid tissue for removal via keyhole surgery – owing to a cancer risk suggests that their evaluation has been inadequate. And the FDA is to convene a panel to re-evaluate morcellators, and is also considering moving another allegedly unsafe type of gynaecological device, vaginal surgical meshes, to a higher risk category. Perhaps the FDA is not too strict, but too lax.
J&J’s move came two weeks after the FDA posted a safety advisory about morcellators, saying that it “discouraged” their use in hysterectomy or the removal of uterine fibroids, based on data indicating that the process carries a risk of spreading unsuspected cancerous tissue, particularly uterine sarcomas, beyond the uterus.
According to the FDA, around one in 350 women who are undergoing hysterectomy or myomectomy for fibroids have undiagnosed uterine sarcoma, and there is no reliable way to determine whether a fibroid is malignant prior to surgery. Morcellators are thought to be used in around 50,000 fibroid removal procedures each year in the US.
Nonetheless the agency has stopped short of ordering a recall of those morcellators that J&J has already sold – the company has merely halted sales of new ones. The FDA said that it will convene the obstetrics and gynecological medical devices panel to discuss laparoscopic power morcellation. No date has yet been set for this meeting.
J&J’s Ethicon subsidiary started selling morcellators in 1998 and currently has three products. J&J said the suspension will affect all of its morcellator products, which go by the names Gynecare Morcellex, Morcellex Sigma and Gynecare X-Tract. It does not disclose sales figures for the devices, but its women’s health division had worldwide sales of $523m in 2012, around 32% of the obstetrics and gynaecology market. This figure is forecast to rise to $585m in 2020, according to EvaluateMedTech.
The FDA’s obstetrics and gynecological panel has already met to discuss the safety of vaginal meshes, meanwhile. These meshes are used to provide support when repairing weakened or damaged tissue, in this case usually vaginal prolapse. The devices have been the subject of much controversy and litigation, with J&J, C. R. Bard and Endo Health Solutions facing multimillion-dollar lawsuits over their alleged misuse (Bard’s investors shrug off use of potentially dangerous plastic in implants, June 26, 2013).
The panel recommended that they ought to be moved from class II – moderate risk – to class III. Class III devices are generally those which sustain life or present a potential risk of illness or injury. All class III devices must be granted premarket approval (PMA) before going on sale in the US, whereas lower risk devices are merely compared with an already-approved predicate.
The FDA never put into force the panel’s recommendation, which was made in 2011.
This week Endo managed to settle around 20,000 claims relating to its vaginal mesh products with a payment of around $830m. Analysts painted this as a positive for the company, with UBS saying that any settlement under $1bn “will be considered good news” and Leerink saying that, had a settlement not been reached, damages could have hit the firm for $2bn.
Last February, Ethicon had to pay $3.35m in compensation to a single patient misled about the risks of its Prolift vaginal mesh (J&J’s hip problems worsen with US government probe, February 26, 2013). The pattern here is alarming: just as with its morcellators, Ethicon took the mesh off sale but did not recall it.
Expensive, protracted lawsuits are hardly the ideal outcomes for patients or companies – although a cynic might point out that companies probably make more money from sales of these products than they lose through the courts. More exacting regulation of potentially dangerous products would seem like a better idea.